Hemato-Oncology Testing Market will value USD 8.56 billion







Pune India, Jan. 28, 2023 (GLOBE NEWSWIRE) — The market has been studied for the below mentioned-segmentation and regional analysis for North America, Europe, Asia, South America, and the Middle East and Africa. These are the key regions where the hemato-oncology testing market is operating and is predicted to expand soon. The manufacturers and suppliers involved in the hemato-oncology testing market are present across various countries in the above-mentioned regions.

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The report provides a detailed understanding of the market segments which have been formed by combining different prospects such as cancer type, product, technology, end-user,  and regions. The key driving factors, restraints, potential growth opportunities and market challenges are also discussed in the paragraphs below.
The significant players operating in the global hemato-oncology testing market are F. Hoffman-La Roche Ltd, Thermo Fisher Scientific, Inc., EntroGen, Inc., Abbott Laboratories, Qiagen N.V., Cepheid, Bio-Rad Laboratories, Inc, Illumina, Inc. among others. To achieve a substantial market share in the worldwide hemato-oncology testing market and strengthen their position, manufacturers are pursuing expansion methods such as current developments, mergers and acquisitions, product innovations, collaborations, and partnerships, joint ventures.
The purpose of hemato oncology testing is to diagnose, treat, and study blood cell, bone marrow, and related tissue cancers. These tests are used to diagnose diseases like sickle cell disease, haemophilia, thalassemia, iron deficiencies, leukemia, and other organ cancers. Sales of assay kits and reagents are driven by the demand for drug discoveries, biotechnology research, and the prevalence of infectious diseases. Assay kits reduce ambiguity by providing accurate diagnostic results, which is boosting sales of market. Another major factor contributing to the growth of the market for hemato oncology testing is the availability of advanced molecular techniques for the diagnosis of hemato oncology. The introduction of advanced molecular techniques has been critical in addressing concerns pertaining to blood cancer prognosis, treatment course, and diagnosis. The government, however, has imposed strict rules and is delaying clearance of experimental molecular diagnostic tests, which may adversely affect market growth during the forecast period. Furthermore, in the near future, artificial intelligence (AI) may become more prevalent in cancer diagnosis, resulting in faster market growth. A number of cancer types are being screened using artificial intelligence. AI-based computer algorithms have helped clinicians interpret mammograms for more than 20 years, and this field is rapidly developing and will create more growth opportunities for the market.

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Scope of Hemato-Oncology Testing Market Report:

Report Metric Information
Study Period 2022-2030
Base Year              2022
Forecast Period 2023-2030
Market Share Unit USD Billion
Segments Covered Cancer Type, Product, Technology, End-User, and Regions.

 

Regions Covered North America, Europe, Asia-Pacific, South America, and Middle-East and Africa
Major Players F. Hoffman-La Roche Ltd, Thermo Fisher Scientific, Inc., EntroGen, Inc., Abbott Laboratories, Qiagen N.V., Cepheid, Bio-Rad Laboratories, Inc, Illumina, Inc. among others

Segmentation Analysis

Lymphoma is expected to be the fastest-growing segment in 2022. 

The cancer type segment includes myeloproliferative neoplasms, leukemia, lymphoma, and others. The lymphoma segment is expected to witness the highest growth rate during the forecast period. A growing awareness of personalized medications and other treatment options is predicted to spur segment growth during the forecast period. As non-Hodgkin and Hodgkin’s lymphomas become more prevalent in the U.S, NHL accounts for 4.2% of all cancer cases. NHL is the seventh most common cancer in the U.S., according to the National Institutes of Health (NIH) in 2019.

Services are expected to be the fastest-growing segment in 2022. 

The product segment is services and assay kits & reagents. The services segment is expected to witness the highest growth rate during the forecast period. As a result of increasing awareness of advanced therapies such as personalized medicine and the rise in leukemia and myeloma cancers, the services segment is expected to dominate the global hemato-oncology test market over the forecast period. The segment is also growing as awareness of advanced treatment therapies such as personalized medicine becomes more prevalent.

Services are expected to be the fastest-growing segment in 2022. 

The technology segment is Cytogenetics, PCR, NGS, IHC, and Others. The PCR segment is expected to witness the highest growth rate during the forecast period. This is due to the fact that it is easy to use, affordable, provides accuracy and efficiency, and is widely accessible. The Diagnostic Laboratories of the BloodCenter of Wisconsin debuted the Abbott RealTime IDH1 assay in July 2018. This PCR test can be performed to find genetic variations in the IDH1 gene from patient bone marrow and blood samples. As a result, it is predicted that an increase in the quantity of PCR-based test launches will promote market expansion at the period of forecasting. In a similar vein, Cepheid’s Xpert BCR-ABL Ultra received FDA approval in October 2019 to monitor a person’s risk of developing chronic myeloid leukaemia. With the use of this in-vitro diagnostic process, complete blood samples taken within three hours might yield precise results.

Services are expected to be the fastest-growing segment in 2022. 

The end-user segment is Academic & Research Institutes, Hospitals, and Others. The hospitals segment is expected to witness the highest growth rate during the forecast period. The availability of specialised laboratory settings, the rise in the incidence rate of blood cancers, the wide range of diagnostic tests available, and the prevalence of healthcare professionals who can conduct diagnostic tests and monitor the disease are all factors contributing to the growth that has been seen.

Regional Analysis           

The regional analysis provides a detailed perception of the key regions and the countries. Some of the key countries analyzed for the hemato-oncology testing market include the US, Canada, Mexico, Germany, France, the U.K., Italy, Spain, Russia, China, Japan, India, Brazil, Peru, UAE, South Africa, and Saudi Arabia.

The North American region witnessed a major share. As a major revenue contributor in the region, North America is also a leading contributor globally. The large share of this segment can primarily be attributed to the high incidences of hematologic cancer, the aging population, awareness of advanced treatment methods, and strong presence of industry players in the region. During the forecast period, these trends are likely to drive market growth.

Country Analysis

Germany’s hemato-oncology testing market size was valued at USD 0.21 billion in 2022 and is expected to reach USD 0.62 billion by 2030, at a CAGR of 14.6% from 2023 to 2030.
Heavy smoking and binge drinking are most likely to contribute to the rise in cancer rates across the nation. It is significant that strong institutional frameworks, like the German Cancer Consortium and significant University Medical Center-based Comprehensive Cancer Centers, contribute to the advancement of cancer research in all parts of the country (CCCs).

China’s hemato-oncology testing market size was valued at USD 0.22 billion in 2022 and is expected to reach USD 0.66 billion by 2030, at a CAGR of 14.8% from 2023 to 2030.
There is a strong possibility that the rapid growth of medical tourism in the country will lead to a greater demand for cancer treatment and diagnostic procedures. Furthermore, the rise in cancer cases is encouraging hemato-oncology testing, which is boosting the market growth.

India’s hemato-oncology testing market size was valued at USD 0.17 billion in 2022 and is expected to reach USD 0.50 billion by 2030, at a CAGR of 14.7% from 2023 to 2030.
There is a growing prevalence of blood cancer, and a growing number of academic research institutes actively conducting research. This is expected to lead to the highest growth rate in the market.
Covid-19 Impact
Covid-19 had a major impact on almost all industries, such as electronics, semiconductors, manufacturing, automobile, etc. However, several companies operating in the technology sector have seen increased revenue due to significant changes in consumer preferences toward technological services. In addition, the pandemic has led to significant growth in technology across developing and developed countries.

Furthermore, the growth of this market is mainly driven owing to the rising cases of cancer.

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FDA-Approved Antibiotic Regimen for Multidrug-Resistant TB May Not Work for TB Meningitis


Tuberculosis bacteria, illustration
Credit: KATERYNA KON/SCIENCE PHOTO LIBRARY/Getty Images

An animal model study by investigators at Johns Hopkins Children’s Center demonstrates that an FDA-approved drug regimen for multidrug-resistant (MDR) tuberculosis (TB) may not work against TB meningitis. Their studies in a small cohort of patients provides evidence that a new drug combination is needed to thwart MDR strains in TB meningitis.

The study, published in Nature Genetics showed that the currently approved three-drug combination of bedaquiline, pretomanid, and linezolid (BPaL) that is currently used for TB of the lungs for infected by MDR strains won’t work on TB meningitis due to problems bedaquiline and linezolid have crossing the blood-brain barrier. TB meningitis is considered the worst form of TB and results in an infection of the brain leading to increased fluid and inflammation. Between one and two percent of all TB cases progress to this form of the disease.

“Most treatments for TB meningitis are based on studies of treatments for pulmonary TB, so we don’t have good treatment options for TB meningitis,” said Sanjay Jain, MD, senior author of the study and director of the Johns Hopkins Medicine Center for Infection and Inflammation Imaging Research.

The FDA approved the BPaL antibiotic drug combination to treat MDR strains of TB, especially those the manifest pulmonary TB in 2019. The Hopkins team noted, however, that there is very little data detailing how well the drugs cross the blood-brain barrier. For their research, the investigators created a chemically identical version of pretomanid that would be visible via positron emission tomography (PET) imaging in mouse models. This non-invasive technique allowed the team to measure the drug’s penetration into the central nervous system as well using direct drug measurements in the mouse brains.

In both models PET imaging demonstrated excellent penetration of pretomanid into the brain or the central nervous system. However, the pretomanid levels in the cerebrospinal fluid (CSF) that bathes the brain were several-fold lower than in the brains of mice.

“When we have measured drug concentrations in the spinal fluid, we have found that many times they have no relation to what’s happening in the brain,” said Elizabeth Tucker, MD, a first author and an assistant professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. “This finding will change how we interpret data from clinical trials and, ultimately, treat infections in the brain.”

The researchers then compared the BPaL MDR regimen against the standard treatment for TB, a combination of the antibiotics rifampin, isoniazid, and pyrazinamide, which are used again drug-susceptible forms of TB. The BPaL regimen performed very poorly, killing bacteria at a rate that was 50 times lower after six weeks of treatment compared with the standard TB regimen. The researchers attributed this as likely due to the poor penetration into the brain of both bedaquiline and linezolid.

A small in-human study of six healthy adults, three men and three women aged 20 to 53 used PET imaging show pretomanid distribution to major organs. Results from this study provided similar results compared with the mouse study showing a high penetration of pretomanid into the brain or CNS with cerebrospinal fluid levels lower than those seen in the brain.

“Our findings suggest pretomanid-based regimens, in combination with other antibiotics active against MDR strains with high brain penetration, should be tested for treating MDR-TB meningitis,” concluded Xueyi Chen, MD, a pediatric infectious diseases fellow, who is now studying combinations of such therapies.



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UT Southwestern biochemist, molecular biologist awarded HHMI Emerging Pathogens grants: Newsroom






HHMI Investigator Benjamin Tu, Ph.D., Professor of Biochemistry, holds the Martha Steiner Professorship in Medical Research and is a W.W. Caruth, Jr. Scholar in Biomedical Research and UT Southwestern Presidential Scholar.

HHMI Investigator Kim Orth, Ph.D., Professor of Molecular Biology and Biochemistry, is a W.W. Caruth, Jr. Scholar in Biomedical Research, holds the Earl A. Forsythe Chair in Biomedical Science and is a National Academy of Sciences member.

DALLAS – Jan. 26, 2023 – Two of UT Southwestern’s Howard Hughes Medical Institute researchers in biochemistry and molecular biology will lead separate teams as part of HHMI’s Emerging Pathogens Initiative (EPI) targeting infectious diseases that pose a threat to human health.

A team of six scientists led by Kim Orth, Ph.D., Professor of Molecular Biology and Biochemistry, and a four-university consortium led by Benjamin Tu, Ph.D., Professor of Biochemistry, will receive two of 13 EPI awards. Drs. Orth and Tu are HHMI Investigators.

“HHMI has been extremely insightful in the face of the COVID-19 pandemic to invest in the future,” said Dr. Orth. “If we are going to make headway to prepare for future pandemics, we need to understand emerging pathogens now.”

Dr. Orth and her team will receive $7 million over three years to investigate virulence factors, cellular structures, molecules, and regulatory systems that microbial invaders use to sicken human hosts. The research team includes Josephine Ni, M.D., Assistant Professor of Internal Medicine and Microbiology; Tamia Harris-Tryon, M.D., Ph.D., Assistant Professor of Dermatology and Immunology; Qian Cong, Ph.D., Assistant Professor of Biophysics and in the McDermott Center for Human Growth and Development; Kevin Forsberg, Ph.D., Assistant Professor of Microbiology; and Lisa Kinch, Ph.D., bioinformatics specialist in the Orth lab.

“We put together a ‘dream team’ of investigators to answer fundamental questions about how pathogenic bacteria might evolve from benign strains, and we are incredibly lucky that HHMI decided to fund our ambitious project,” Dr. Orth said.

Dr. Cong is a Southwestern Medical Foundation Scholar in Biomedical Research, and Dr. Forsberg is a W.W. Caruth, Jr. Scholar in Biomedical Research.

Dr. Tu and colleagues at UCLA, California Institute of Technology, and the University of Wisconsin-Madison will receive $9.5 million over three years to search for natural products that could be used to fight emerging pathogens.

“Our consortium is excited to be awarded this opportunity to utilize an integrated approach to discover natural products with novel modes of action for development of next-generation anti-infectives,” said Dr. Tu.

Dr. Tu’s lab is investigating how fundamental cellular processes such as cell growth and division, transcription, translation, mitochondrial homeostasis, and autophagy are coordinated with the metabolic state of the cell. Dr. Tu, UT Southwestern Presidential Scholar and W.W. Caruth, Jr. Scholar in Biomedical Research who holds the Martha Steiner Professorship in Medical Research, is recipient of the 2014 Norman Hackerman Award in Chemical Research and the 2021 Edith and Peter O’Donnell Award in Science from TAMEST (The Academy of Medicine, Engineering and Science of Texas), among others.

Dr. Orth’s lab has advanced the understanding of the basic biochemical mechanisms underlying many bacterial infections by identifying new ways that invading bacteria hijack and deregulate a cell’s signaling systems. Dr. Orth, who is a W.W. Caruth, Jr. Scholar in Biomedical Research and holds the Earl A. Forsythe Chair in Biomedical Science, is one of 24 members of the National Academy of Sciences at UT Southwestern and is one of 12 members of the American Association for the Advancement of Science at UT Southwestern. She is a recipient of the 2010 Norman Hackerman Award in Chemical Research and the 2011 Edith and Peter O’Donnell Award in Science from TAMEST.

About UT Southwestern Medical Center

UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes, and includes 24 members of the National Academy of Sciences, 18 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,900 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 4 million outpatient visits a year.





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Argonne researchers share in Chicago Innovation Award for COVID wastewater testing


Newswise — Argonne’s collaboration with the Discovery Partners Institute helps public health officials track COVID variants and infectious diseases across Illinois. The system was honored among the most innovative new products or services brought to market in 2022.

The U.S. Department of Energy’s Argonne National Laboratory is among the winners of a 2022 Chicago Innovation Award for its work on a COVID wastewater surveillance system. In collaboration with the Discovery Partners Institute, Argonne researchers assembled one of the first teams in the nation to reliably analyze samples of raw sewage for evidence of SARS-CoV-2 RNA in 2021, providing real-time information to help both the Chicago Department of Public Health and the Illinois Department of Public Health through the pandemic.

In some ways, sewers are the birthplace of epidemiology — the study of disease distribution and patterns in a population. In 1854, John Snow studied a deadly outbreak of cholera in London. He discovered that victims of the outbreak had all consumed water from the Broad Street pump. The water was contaminated with sewage from the River Thames, which contained high concentrations of cholera bacteria. Snow convinced officials to remove the handle from the Broad Street pump, saving countless lives.

“Because of our biosafety expertise, we knew the samples would be safe, but we also knew the researchers would be safe.” — Sarah Owens, sequencing laboratory manager in Argonne’s division of Biological Sciences

But John Snow was only equipped with a map and a primitive microscope. Today, epidemiologists can employ a variety of high-tech tools to take the guesswork out of disease tracking. What’s truly innovative about Argonne’s research is the way researchers can accurately pinpoint specific segments of a virus’s genetic material from a complex sample: sewage.

Argonne’s expertise lies in sequencing the virus’s RNA to track which variants are present in Illinois and to monitor for strains that the Centers for Disease Control and Prevention and World Health Organization have designated as variants of concern. But unlike clinical samples and the at-home tests we’re familiar with, wastewater is more complex. It contains a mixture of several different types of microorganisms.

Sarah Owens, sequencing laboratory manager in Argonne’s division of Biological Sciences, is among the honorees for the Chicago Innovation Award. According to Owens, “We knew that this was going to be a challenge to sequence from wastewater because of the complexity of the community and the nature of the matrix itself. You know it’s dirty. It’s chunky, it has all of these different qualities.”

Think of it as looking for a needle in a haystack made of human waste. Researchers don’t just need to know whether SARS-CoV-2 RNA is present, they need to know which variants are circulating and where.

The success of the project also relies on the network of collaborators across the state, from water treatment plant workers who collect the samples to experts at the University of Illinois Chicago who isolate the genetic material so that Argonne can sequence. Argonne was also ready to support the project because the lab was already equipped with a Biosafety Level 2 laboratory.

“We had a lot of experience working with samples that are potentially infectious in the past. Because of our biosafety expertise, we knew the samples would be safe, but we also knew the researchers would be safe,” said Owens.

Argonne’s work of monitoring wastewater for infectious diseases will continue to be an important and essential tool for public health, not just during the ongoing COVID pandemic, but also as communities prepare for possible outbreaks of everything from flu and RSV to polio and mpox to other emerging diseases. Knowing what diseases are present in the population can help health officials and healthcare providers understand what vaccines, medicines and supplies they might need to treat people and what precautions they should take to keep people safe.

This information can also help public health officials understand the true scope of an outbreak in areas that might not have access to accurate testing data from other sources. Wastewater monitoring during COVID has helped doctors determine if people are infected in a particular area, which strains of the virus are circulating in the area, and even which types of monoclonal antibody treatments would be most effective in treating patients. All of this information translates into lives saved from dangerous and potentially deadly health conditions.

The annual Chicago Innovation Awards is the Chicago region’s foremost recognition of the most innovative new products or services brought to market each year. 

The research pilot was funded by the Walder Foundation, and this full-scale project is now being funded by the Illinois Department of Public Health and the Chicago Department of Public Health.  It is being led by the University of Illinois-directed Discovery Partners Institute and includes researchers from Argonne, the University of Illinois Chicago, and Northwestern University.





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Immunoassay Market Size to Worth Around USD 51.33 Bn by


Ottawa, Jan. 24, 2023 (GLOBE NEWSWIRE) — The global immunoassay market size was accounted at USD 32.46 billion in 2022. The rising prevalence of infectious & chronic diseases, increasing awareness for early diagnosis, technological development in immunoassays, and growing usage of immunoassays in drug & alcohol testing are the key factors driving the immunoassay industry growth. Furthermore, incorporating microfluidics & biochemicals in immunoassays and increasing healthcare investments in emerging economies present significant growth opportunities for market participants.

COVID-19 and immunoassay Market:

The emergence of the COVID-19 pandemic positively impacted the immunoassay market in 2020-2021 with an increase in diagnostic activities & treatment procedures. Moreover, a rise in R&D activities to develop diagnostics such as molecular tests, immunoassay reagents, and devices also drove the market growth. COVID-19 diagnostic procedures and products have created immense opportunities in the healthcare industry.

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The only effective strategy for limiting and managing the spread of illnesses and potential causalities in the absence of a vaccine or medication is to diagnose them through immunoassay reagents and instruments. Rapid testing has proven to be an effective, quick, and simple molecular test for broad-scale COVID-19 surveillance. Moreover, diagnostic manufacturers such as Thermo Fisher Scientific, Abbot, Roche, and Bio-Red have developed various technologies to improve the detection and treatment of COVID-19.

Key Takeaways:

  • North America market has accounted revenue share of 36% in 2022. 
  • Asia Pacific market is poised to grow at a fastest rate from 2023 to 2032. 
  • By product, kit and reagent segment has accounted revenue share of 61% in 2022. 
  • By product, the software and services segment is poised to grow at a CAGR of 5.68%.
  • By technology, the ELISA segment has accounted revenue share of 61% in 2022.
  • By application, the infectious disease segment has accounted revenue share of 31% in 2022.
  • By end user, the hospital & clinical segment has generated revenue share of 31% in 2022. 

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Scope of the Report

Report Attributes Details
Revenue Forecast by 2030 USD 51.33 Billion
CAGR 4.68% from 2023 to 2032
North America Revenue Share 36% in 2022
Infectious Disease Revenue Share 32% in 2022
Base Year 2022
Forecast Year 2023 to 2032
Key Players Demant A/S, Starkey Laboratories, Inc., Cochlear Ltd., RION Co., Ltd, Microson, GN Store Nord A/S, Sonova Group

Market Drivers:

Infectious diseases boosting the market growth 

Globally, there has been an increase in infectious diseases due to rapid urbanization and climate change. According to the CDC, in 2018, the number of patient visits to ER for infectious or parasitic diseases was 3.2 million. In the same year, the number of patients visiting the physicians’ office was 7.2. According to the WHO, contagious diseases kill over 17 million people yearly. Due to the increasing number of infectious disease cases, the market for immunoassays will rapidly grow and expand into more developing countries due to poor lifestyles, low health knowledge, and environmental factors.

Automated immunoassay booming the market

Many manufacturing processes are being automated nowadays, particularly in the medical field. Automating immunoassays is convenient, cost-effective, reduce variability, and, most importantly, eliminates the possibility of human error. The rapid increase of automation for immunoassays in labs and clinics worldwide provides more accurate test results. As a result of process automation, the market would continue to grow at a rapid pace. Automated immunoassay shows several benefits, such as avoiding time-consuming, easy washing steps, reducing reagent consumption, providing greater sensitivity, and facilitating improved performance.

Restrains:  

The uncertain regulatory environment hinders the market growth

Regulatory authorities provide regulatory guidelines for the manufacturing and commercialization of immunoassays. However, the time required to receive regulatory approval for immunoassays is still being determined, and investment in R&D may only succeed if the regulatory authority gives permission. 

On the other hand, stringent demands for the approval of immunoassay instruments and consumables, as well as technical challenges with immunoassay kits, are expected to impede the growth of the immunoassay reagents and devices market during the forecast period. Additionally, a lack of skilled professionals and an unsuitable reimbursement scenario may pose additional challenges to the market growth in the forecast period.

Opportunities:  

Microfluidics technology integration in immunoassays provides attractive growth opportunities.

Immunoassays are used in various applications, including pharmaceutical analysis, medical diagnostics, food testing environmental, and scientific investigations, due to their specificity and sensitivity. However, many immunoassays involve a series of labor-intensive and time-consuming washing, mixing, and incubation steps.

Immunoassay immune agents are more expensive, and the usage of immune agents can be reduced if the system is miniaturized. As a result, microfluidic systems, called lab chips or total micro analysis-system, have received attention due to advantages like integration, miniaturization, and automation.

Microfluidics is a new and diverse technology that uses fluids in microenvironments in a standardized manner, making them distinct from traditional nitrocellulose tests. They are the ultimate solution for miniaturizing biomarker immunoassays because they combine the benefits of simplified fluidics, fewer reagents, and much shorter assay times. These devices used various methods for antibody immobilization, including passive adsorption, which is familiar with plastic surfaces, and covalent binding, where salinization appears to be the foundation of most covalent binding techniques. And a combination of the two approaches, as well as some antibody-oriented methods, still need to be used.

Market Segmentation: 

By Product: 

Based on the product, the immunoassay market is categorized into kits, reagents, and analyzers. The reagents and kits segment dominated the immunoassay market with an 61% market share in 2022. The high demand for kits and reagents increases due to the growing number of home pregnancy tests and increased blood testing due to a rise in infectious diseases. 

By Technology: 

Rapid tests, ELISA, ELISpot, western blotting, and radioimmunoassay are the most commonly used technologies in the immunoassay market. Rapid tests dominated the market in 2022 with highest market share. Rapid tests detect HCV, HIV HBV, and HCG antibodies in donated blood. Rapid tests are preferred in point-of-care diagnosis in emergencies and during primary care. Rapid test use has increased since the pandemic as they are contactless and give almost immediate results.

By Specimen: 

The immunoassay market is classified into saliva, blood, urine, and other niche specimens. The blood specimens segment is expected to grow at the fastest rate in the forecast period, owing to an increase in infectious and chronic diseases. 

By Application: The global immunoassay market, based on the application, is categorized into infectious diseases, oncology, endocrinology, cardiology, and blood screening. The infectious diseases segment dominated the market with an 31% market share in 2022, whereas infectious diseases are expected to grow at a healthy CAGR of during the projected period. 

Additionally, the high share of infectious diseases can be attributed to rising rates of HIV, influenza, malaria, and new COVID-19 variants. New product launches in infectious disease testing are propelling the market forward.

By End-User: 

The global immunoassay market, based on end-users, is categorized into hospitals, pharmaceutical & biotech companies, clinical laboratories, and blood banks. The hospital segment dominated the market in 2022 with an 31% market share due to the increasing number of hospitals. With the ongoing changes in the healthcare industry, there is a greater need for hospitals with advanced facilities.

Blood banks are expected to expand during the forecast period due to an increase in the number of infectious diseases tested in these laboratories during the screening and processing of donated blood. Furthermore, because ELISA is simple to perform and requires few specialized instruments and equipment, it is widely used in blood banks.

Regional Landscape: 

Europe has held largest market share in 2022 due to the massive burden of COVID-19 cases in most countries and the emphasis on tests for controlling the spread of the infection. For Instance, according to (WHO), 15.2 million patients were registered in France as of 8th January 2022. 

Moreover, key players are working on research and development, and new product launches in the Europe region’s significant players propelled the market’s growth. For Instance, In Nov 2022, Getein Biotech Inc. introduced new POC solutions, including analyzers and rapid tests. Getein will debut the MAGICL 6000 at MEDICA 2022, a compact and innovative chemiluminescence immunoassay analyzer ideal for mid to high-workflow laboratories that requires a one-step chemiluminescence solution.

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Recent Developments in the Immunoassay market:

  • In 2021, Thermo Fisher Scientific inc. launched its fully automated analyzers, Thermo Scientific gallery enzyme master and thermos scientific gallery plus enzyme master, specially designed for enzyme assay applications.
  • In 2021, Beckman Coulter launched its fully automated and qualitative Covid 19 immunoassay, Access SARS-COV-2 lgG. The immunoassay is a fully quantitative lab-based immunoglobulin G (lgG) serology test intended to measure the number of antibodies against the virus that causes COVID -19 
  • 2021, F. Hoffmann -LA Roche launched the SARS-Cov-2 Rapid Antigen test Nasal with the patient collection.

The key players operating in the immunoassay market

  • Abbott Laboratories
  • Danaher Corporation (Beckman Coulter)
  • Quidel Corporation
  • Ortho Clinical Diagnostics
  • Sysmex Corporation
  • Bio-Rad Laboratories, Inc.
  • Becton, Dickinson, and Company
  • F. Hoffmann-La Roche AG
  • Thermo Fisher Scientific, Inc.
  • Siemens Healthinners

Segments covered in the global immunoassay market:

By Product

  • Reagents & Kits
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  • Analyzer
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    • By Purchased Mode
      • Rental Purchased
      • Outright Purchased

By Technology

  • ELISA
    • By generation
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      • Second-generation & Below
  • Rapid Tests
  • ELISpot
  • Western Blotting
  • Radioimmunoassay
  • Other technologies

By Specimen

  • Blood
  • Saliva
  • Urine
  • Other Specimen

Immunoassay Market by Application

  • Infectious diseases
  • Endocrinology
  • Oncology
  • Bone and mineral disorders
  • Cardiology
  • Blood screening
  • Autoimmune Disorders
  • Allergy Diagnostics
  • Toxicology
  • Newborn Screening
  • Other Application

By End User:

  • Hospitals & Clinics
  • Clinical laboratories
  • Pharmaceutical & Biotechnology Companies and CRO
  • Blood Banks
  • Research & Academic Laboratories
  • Home care setting

By Region:

  • North America
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia Pacific
  • LAMAEA

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An Inconvenient Truth of Inadequate Global Response to Antimicrobial Resistance


In a recent analysis of countries’ efforts to combat the development of antimicrobial resistance, investigators offer an understated conclusion, that “international response might not be commensurate with (its) scale and severity.”

Jay Patel, Global Health Governance Programme, Usher Institute, University of Edinburgh, Edinburgh, UK and colleagues found that their evidence “suggests that simply developing a NAP (national action plan) might not necessarily make a country prepared to respond to the threat of antimicrobial resistance.”

In accompanying commentary in The Lancet Infectious Diseases, Alessandro Cassini, MD, MSc, Cantonal Doctor Office, Canton of Vaud, Lausanne, Switzerland, and Evelina Tacconelli, MD, PhD, Infection Prevention and Control Unit, Infectious Diseases Service, Lausanne University Hospital, Switzerland, point out that there were more than 1.2 million deaths directly attributable to infections with resistant bacteria in 2019, and find that the analysis by Patel and colleagues yields a “generally bleak overview of the commitment of various countries to effectively overcome antimicrobial resistance.”

In the analysis of global response in 2020-21, which Patel and colleagues characterize as the first to comprehensively examine the international response to antimicrobial resistance, 114 countries are ranked on having and implementing a governance framework covering 18 domains and including over 50 indicators in 3 integral areas: policy design, implementation tools, and monitoring and evaluation.

Overall country scores were derived from the mean average of all governance areas; and composite scores for each area from the mean value of each domain. Aggregated indicator scores for domains and governance areas were transformed into a scale from 0 (worst) to 100 (best) by 3 of the investigators, who were blinded to the respective countries; and who then met unblinded to resolve any disagreements in scoring and to reach consensus agreement.

The investigators indicated that their “grading” criteria were drawn, in part, from the countries’ NAPS, and their entries in the WHO Tripartite Antimicrobial resistance Country Self-Assessment Survey (TrACSS), the Global Antimicrobial Resistance and Use Surveillance System GLASS), the Global Antimicrobial Resistance Research and Development Hub, the WHO 2018 South-East Asia Region Situational Analysis, and the WHO 2020 Immunization Dashboard.

Perhaps not unexpectedly, the investigators found lower scores (46-48) in the countries that also ranked in the low- and middle-World Bank income groups. Norway ranked highest, mean 85 (SD 32) and the Federated States of Micronesia lowest (28 [37]).The highest scoring domain was participation (83 [16]) and the lowest scoring domains were accountability (30 [18]) and feedback mechanism (30 [25]).

“Education was the lowest scoring domain of all implementation tools,” Patel and colleagues observed, “highlighting that basic and continuous education for healthcare workers has not been robustly established inmost countries.”

Sustainability, which considered whether countries had assessed the budget requirements of their NAPS, was the lowest scored indicator. Only Austria receiving a positive score for sustainability.

Cassini and Tacconelli welcomed the approach taken by the investigators, indicating that their assessment tool, “should be considered an essential component of, and integrated into the multifaceted country approach to antimicrobial resistance.”

The next step, recommended Cassini and Tacconelli, is to develop appropriate and easily measurable outcome indicators, which should be regularly and independently measured at the country level and used as a baseline for further comparisons.



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Lassa fever: Edo, Ondo, Bauchi states account for 84% of cases, says NCDC | The Guardian Nigeria News


The Nigeria Centre for Disease Control and Prevention (NCDC) has said that Edo, Ondo, and Bauchi states account for 84 per cent of Lassa fever infection in the country.

The Director-General, NCDC, Dr Ifedayo Adetifa, said this in an Interview with the News Agency of Nigeria(NAN) on Sunday in Abuja.

Adetifa said that between Jan. 2 and Jan. 15, the country recorded 369 suspected cases of Lassa fever. He said out of which 105 were confirmed positive from 30 LGAs in 10 states.

The NCDC said that the 10 states were Ondo, Edo, Ebonyi, Bauchi, Benue, Kogi, Imo, Oyo, Plateau and Nasarawa States

He said that there had been seven deaths with a Case Fatality Rate (CFR) of 6.7 per cent in the country.He said that since 2017, the NCDC through the Lassa Fever Technical Working Group (TWG) had been been offering support to all states and responding to Lassa fever especially the high-burden states of Edo, Ebonyi and Ondo.

”Support offered includes capacity building and training healthcare workers on infection prevention and control, clinician training on Lassa fever case management (including the provision of Ribavirin, consumables such as intravenous fluids, antibiotics, personal protective equipment (PPE), body bags, etc.),

“The development and dissemination of protocols and guidelines, the set up and maintenance of a network of laboratories for Lassa fever diagnosis (including training, maintaining quality management systems, provision of all consumables required for testing).

”As well as risk communication and community engagement activities to raise awareness,” he said.

According to Adetifa, at the end of November 2022 and ahead of the projected rise of Lassa fever cases, the NCDC prepositioned supplies for case management, infection prevention and control and laboratory diagnosis, among others in all historical Lassa fever hotspots including Edo.

He said that in December 2022, the agency in collaboration with partners, Federal and state-level stakeholders successfully conducted the finalisation and validation of a five-year strategic plan to reduce the Lassa fever fatality ratio in Nigeria to less than 10 per cent.

The NCDC boss said that in the last six years of the Lassa fever response in the country, there had been an establishment of Public Health Emergency Operations Centres (PHEOC) to ensure effective multi-sectoral coordination for early containment of outbreaks.

“Timely deployment of multi-sectoral National Rapid Response Teams (NRRT) on request. Yearly distribution of response commodities medicines (Ribavirin) and personal protective equipment (PPE), social behaviour change communication (SBCC) materials, thermometers, tents, to Epidemiology Departments of State Ministries of Health and treatment centres.

“Routine support of testing state laboratories with testing kits, reagents and consumables. Support for engagement of contact tracers and supervisors for enhanced surveillance and active case search.

“Support designated treatment centres with equipment such as ambulances, dialysis machines, medicines, PPE, generating sets, etc. Deployment of surge staff (healthcare workers) to support overwhelmed treatment centres,” he said.

According to him, there has been training and retraining of healthcare workers on Lassa fever response, case management and IPC as well as development and dissemination of Lassa fever guidelines on case management, Infection Prevention and Control (IPC), preparedness and response.

“Implementation of targeted rodent control measures in high-burden LGAs in collaboration with the World Health Organization and Federal Ministry of Environment. Dissemination of alert and advisory letters to Commissioners of Health to institute appropriate response and preparedness measures.

“Deployment of Surveillance Outbreak Response Management and Analysis System (SORMAS). State presence of NCDC liaison officers in high-burden states.

“High-level advocacy visits to the Governor and Commissioner of Health in high-burden states. Implementation of Nigeria Lassa Fever Epidemiological Study and other research activities in high burden states,” he said.

Adetifa, therefore, advised Nigerians to reduce the risk of Lassa fever infection and keep their environment clean always.

“Block all holes in your house to prevent rats from entering. Cover your dustbins and dispose of refuse properly.

“Communities should set up dump sites very far from their homes to reduce the chances of having rodents within their homes. Store foodstuff like rice, garri, (cassava flakes) beans, corn/maize etc. in containers that are well covered with tight-fitting lids,” he said.

He said that Nigerians should avoid drying foodstuff outside on the ground or roadside where it would be at risk for contamination and also avoid bush burning which could lead to the displacement of rats from bushes to human dwellings.

“Eliminate rats in homes and communities by setting rat traps and other available means. Practice good personal and hand hygiene by frequently washing hands with soap under running water /or use of hand sanitisers when appropriate,” he explained.

He also advised Nigerians to visit the nearest health facility if they notice any of the signs and symptoms associated with Lassa fever as mentioned earlier.

“Avoid self-medication,” he said.

He called on healthcare workers to always practice standard precautions.

“Wear gloves and other appropriate personal protective equipment while handling patients or providing care to an ill patient/relative.

“Healthcare workers should maintain a high index of suspicion for Lassa fever.

“Be vigilant and consider a diagnosis of Lassa fever when seeing patients presenting with febrile illness.

“Healthcare providers should report all suspected cases of Lassa fever to their local government Disease Surveillance and Notification Officer for immediate access to healthcare,” he said.

He said this was essential because early identification and treatment of cases appear to be more effective and save lives.

According to him, any febrile illness that has not responded to 48 hours of use of anti-malaria or antibiotics should raise an index of suspicion for Lassa fever.

He said that the Federal Government and the Federal Ministry of Health through the NCDC continue to offer both technical and material support to all states when responding to infectious diseases of public health importance including Lassa fever.

Adetifa said that the agency is the country’s national public health institute, with the mandate to lead the prevention, preparedness, and response to public health emergencies caused by communicable diseases.

“The mission of the NCDC is to protect the health of Nigerians and one of the strategies in attaining national health security is the capacity building of states to have a skilled workforce to promptly respond to outbreaks of public health importance,” he said.

NAN, reports that Lassa virus is transmitted to man by infected multi-mammate rats and humans become infected from direct contact with the urine and faeces of the rat carrying the virus.

People also contract the disease by touching soiled objects, eating contaminated food, or exposure to open cuts or sores.

Secondary transmission from person to person can also occur as a result of exposure to the virus in the blood, tissue, urine, faeces or other bodily secretions of an infected patient.

Lassa fever can also be passed between patients and staff at poorly equipped hospitals where sterilisation and protective clothing are not standard.





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COVID is endemic. Here’s how we keep it that way


On Sept. 18, President Biden famously said “the pandemic is over.” He very quickly followed that up by saying: “We are doing a lot of work on it.”

These notions may sound contradictory, but they are indeed the way to approach the concept of endemicity; combating COVID-19 will take ongoing and hard work.

Saying we are exiting the emergency phase, which the World Health Organization also signaled in September, does not mean COVID is over. Unfortunately, COVID will never be over. This virus is not eradicable.

Smallpox was successfully eradicated worldwide in 1979, not only because of the vaccine but because of some unique characteristics of the virus, including its lack of an animal reservoir, pathogenic features that made it easy to quickly recognize in those who have the disease and a short period of infectiousness. Smallpox infection also conferred natural immunity for life.

SARS-CoV-2, which causes COVID-19, has none of these features. It is found in 29 species of animals, at least, which means we will always be dealing with COVID in the medical system. 

In August, the Centers for Disease Control and Prevention released its latest guidelines for COVID-19, which dramatically streamlined the approach to protecting oneself and to understanding personal risk. These guidelines acknowledged the prevalence of natural immunity and no longer distinguished between vaccinated and unvaccinated in isolation and quarantine recommendations. Asymptomatic testing was no longer recommended. Masking in health care settings was no longer recommended as of September if community transmission levels were low. 

As is always the case with new guidelines, the response from experts was mixed. Some agreed that it was time to learn to live with the virus with minimal disruptions to life while others pointed out that the daily death toll was still unacceptably high — and that public health involves sacrifices for the greater good.

It has since become clear, however, that many hospitalizations officially counted as caused by the coronavirus were actually of patients who happen to be infected but were admitted for other reasons. That almost certainly remains true with the host of highly transmissible new variants like XBB.1.5, the so-called “Kraken” variant.

Because everyone admitted to most hospitals is still routinely tested for the coronavirus (despite the main U.S. infection control organization recommending against this practice), many patients admitted for other ailments also test positive. This inflates the official number of COVID-19 hospitalizations. Miscategorized hospitalizations lead to miscategorized deaths.

An analysis of Los Angeles County + USC Medical Center data found that less than one-third of official hospitalizations attributed to COVID were meaningfully related to the coronavirus. In Massachusetts, over 70% of “COVID” hospitalizations are similarly “with” rather than “for” COVID-19. This of course is consistent with the fact that over 95% of Americans have been infected and/or vaccinated. The resulting strong population immunity coupled with the less-virulent nature of omicron strains is resulting in much less severe clinical outcomes.

Overcounting hospitalizations and deaths from COVID in the U.S. due to antiquated screening policies can sow discord and differing recommendations across the country in terms of boosters and masks. However, when public health rules differ from county to county and state to state — and more importantly when they don’t seem to make sense — trust in public health suffers.



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Study shows increase in medical encounters six months post-SARS-CoV-2 infection, with vaccination lowering persistent symptoms risk


In a recent study published in JAMA Network Open, researchers identified factors related to PCC [post-COVID-19 (coronavirus disease 2019] symptoms and assessed changes in PCC medical visits.

Study: Persistent COVID-19 Symptoms at 6 Months After Onset and the Role of Vaccination Before or After SARS-CoV-2 Infection. Image Credit: CROCOTHERY/Shutterstock
Study: Persistent COVID-19 Symptoms at 6 Months After Onset and the Role of Vaccination Before or After SARS-CoV-2 Infection. Image Credit: CROCOTHERY/Shutterstock

Background

COVID-19 patients may present with symptoms persisting for several months post-infection, referred to as ‘long COVID’. Further research conducted to improve understanding of long COVID-associated factors could aid in policy-making and the development of preventive strategies. Previous studies have documented COVID-19 vaccines to protect against COVID-19 severity outcomes such as hospitalizations and deaths; however, the association between COVID-19 vaccination and long COVID is unclear.

About the study

The present study investigated PCC-associated risk factors and changes in PCC-associated medical consultations over time.

The study utilized EPICC (epidemiology, immunology, and clinical characteristics of emerging infectious diseases with pandemic potential) study data implemented by the United States (US) MHS (military health system). Adult MHS beneficiaries testing SARS-CoV-2-positive between 28 February 2020 and 31 December 2021 were included and followed up for one year.

The study outcomes comprised survey-documented symptoms of SARS-CoV-2 infections in six months post-acute COVID-19 and the international statistical classification of diseases and related health problems, 10th revision diagnostic codes documented in medical records after six months of acute COVID-19 versus three months before acute COVID-19. 

The MHS beneficiaries (dependents, retirees, and active individuals) were enrolled in the EPICC trial through online and offline pathways. EPICC study eligibility included SARS-CoV-2 testing, the presence of SARS-CoV-2 infection-like disease, and/or SARS-CoV-2 exposure from known contacts, which was expanded in 2021 to include COVID-19 vaccination.

For the present study, the date of the onset of symptoms or the first SARS-CoV-2-positive result was dated before 31 December 2021. COVID-19 status was based on reports of PCR (polymerase chain reaction) analysis, documented in the healthcare records, self-reported throat or nasal swab test results indicating COVID-19, as mentioned in the survey, or specimens obtained during the study. The team excluded 549 individuals with suspected re-infections (SARS-CoV-2-positive results >3.0 months apart).

Clinical and demographic details were obtained using case report forms (CRF) from individuals recruited at military treatment facilities beginning in November 2020. All individuals filled out web-based surveys quarterly, and additionally, individuals recruited prior to November 2020 filled out catch-up surveys. Individuals who documented SARS-CoV-2 infection symptoms were queried regarding the date for onset of symptoms, COVID-19 severity, and duration.

For analyzing the probable protective effects of COVID-19 vaccines, surveys filled out on dates nearest to 1.0 months, 3.0 months, 6.0 months, 9.0 months, and 12.0 months post-onset of symptoms were retained. Individuals who had received COVID-19 vaccines two weeks before the survey were excluded from the analysis. The CCI (Charlson comorbidity index) scores were calculated for comorbid conditions documented by the MDR (military health system data repository) in the calendar year before the onset of the symptoms of COVID-19. Poisson regression modeling was performed, and risk ratios (RR) were calculated.

Results

A total of 1,832 individuals were analyzed, of which 1,226 (67%) were aged between 18 and 44. The mean participant age was 41 years, 61% (n=1,118) were men, 77% (n-1,1413) were non-vaccinated during the acute infection period, and 71% (n=1,290) had no comorbid conditions. COVID-19-associated hospitalizations were documented for 13% (n=236) of individuals. Among the participants, 40% (n=728) had an illness lasting for ≥28.0 days [28 days to 89 days of illness duration among 364 individuals (20%) and ≥90.0 days of illness in another set of 364 (20%) individuals].

The most frequently observed symptoms rated to be of moderate intensity or severe in intensity a month post-symptom onset comprised fatigue (7.0%, n=47), intolerance to exercise (6.0%, n=43), breathing difficulties (5.0%, n=34), taste and/or smell loss (5.0%, n=39), and cough (4.0%, n=28). Among individuals who completed the six-month surveys (62%, n=1,138), 111 (10%) reported experiencing a symptom associated with COVID-19.

Individuals who had not received COVID-19 vaccines before infection (RR of 1.4), documented moderate illness (RR of 1.8) or severe illness (RR of 2.3) during the initial COVID-19 period, had a longer duration of hospital admission (risk ratio of 1.1 per day in the hospital) and had CCI scores ≥5.0 (RR of 1.6) shows a greater likelihood of documenting ≥28.0 days of COVID-19 symptoms.

Among non-vaccinated individuals, post-COVID-19 vaccination was linked to a 41.0% lesser risk of experiencing symptoms at six months (risk ratio of 0.6). Individuals had a greater risk of respiratory symptoms-related medical visits (RR of 2.0), diabetes-related medical visits (RR of 1.5), neurological symptoms-related medical visits (RR of 1.3), and medical visits for mental well-being (RR of 1.3) at six months after the onset of symptoms in comparison to those before SARS-CoV-2 infection.

Overall, the study findings showed that severe COVID-19 during the initial period, greater CCI scores, and unvaccinated status were associated with an increased risk of documenting SARS-CoV-2 infection symptoms lasting ≥28.0 days. In addition, SARS-CoV-2-positive individuals showed a greater likelihood of seeking medical consultation for diabetes, neurological, mental well-being, and respiratory system-associated illness for ≥6.0 months post-onset compared to their pre-SARS-CoV-2 infection medical care utilization patterns. The findings underpin the administration of SARS-CoV-2 vaccinations.



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Trial Of J&J HIV Vaccine Halted After ‘Disappointing’ Failure


The National Institute of Allergy and Infectious Diseases said Wednesday that Johnson & Johnson’s experimental vaccine does not effectively prevent HIV infections and that the Phase 3 clinical trial was closing. This development follows the failure of a similar vaccine candidate in 2021.


Stat:
HIV Vaccine Being Developed By Johnson & Johnson Fails Trial


Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson. (Branswell, 1/18)


NBC News:
Another Major HIV Vaccine Trial Fails


“It’s obviously disappointing,” Dr. Anthony Fauci, who as the long-time head of the National Institute of Allergy and Infectious Diseases (NIAID) was an integral partner in the trial, said of the vaccine’s failure. However, he said, “there are a lot of other approaches” early in the HIV-vaccine research pipeline that he finds promising. (Ryan and Lavietas, 1/18)


Reuters:
J&J To Discontinue HIV Vaccine Trial


The trial involved administering two different types of a shot, which uses a cold-causing virus to deliver the genetic code of HIV, spread over four vaccination visits in a year. J&J used similar technology for its COVID-19 vaccine. The study, which began in 2019, was conducted at over 50 sites and included about 3,900 gay men and transgender people – groups that are considered vulnerable to the infection. (Leo, 1/18)


The New York Times:
The Only H.I.V. Vaccine In Advanced Trials Has Failed. What Now? 


The latest defeat sets progress toward a vaccine back by three to five years, experts said. … An ongoing study called PrEPVacc in Eastern and Southern Africa is evaluating a combination of experimental H.I.V. vaccines and preventive drugs. Scientists have made headway in developing powerful antibodies that can neutralize the virus. And they are testing new vaccine technologies, including mRNA, against H.I.V.(Mandavilli, 1/18)

In other news about tuberculosis vaccine development —


CIDRAP:
WHO Announces Effort To Speed Development Of TB Vaccines


The World Health Organization (WHO) announced plans yesterday to accelerate the licensing and use of effective vaccines against tuberculosis (TB). … There is currently only one licensed TB vaccine in use—the bacille Calmette-Guerin (BCG) vaccine—but it is 100 years old and only effective in children under 5. (Dall, 1/18)


This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.



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