Respiratory Syncytial Virus Infections

The year started well for the biotechnology industry. Steady dealmaking coupled with a rebound in initial public offerings helped lift investor confidence and, with it, drugmaker stocks.While that optimism has moderated somewhat since, a series of decisions by the Food and Drug Administration over the next three months could help the sector sustain its upturn. The agency may expand approvals for two cancer cell therapies and clear a third vaccine for respiratory syncytial virus. Sanofi and Regeneron await a decision on a lucrative new use for their top-selling Dupixent, while Geron could see decades of drug research finally pay off.Here are five FDA decisions to watch in the second quarter.CAR-T therapies for early multiple myeloma treatmentThe FDA this quarter could broaden the use of two cell therapies for multiple myeloma in decisions potentially worth billions of dollars to their respective developers.By April 5, the agency will decide whether to clear Johnson & Johnson and Legend Biotechs Carvykti for use in myeloma patients as early as after one relapse. That decision could be accompanied by a similar OK for Bristol Myers Squibbs Abecma and open up use of the therapies, which are currently only available in the U.S. for people with more advanced disease.European regulators have already endorsed earlier use of Abecma and Carvykti based on trial data showing they help people live longer without their disease progressing. But the FDA has appeared less supportive. The agency delayed a decision on Abecma last year and held a March advisory meeting to more closely scrutinize the data for it and Carvykti. In briefing documents, staff scientists flagged an apparent increase in the risk of death early on in the clinical trials of both therapies.The companies attributed that finding to limitations in the bridging therapies study participants could receive while waiting for CAR-T treatment. Panelists were convinced and backed both, agreeing that those issues likely wouldnt occur as frequently in practice.Nonetheless, the regulatory scrutiny suggests that the FDA might put new safety restrictions on Carvykti and Abecma if it chooses to clear them for earlier use. Jonathan GardnerModernas vaccine for RSVCOVID-19 vaccine makers Pfizer and Moderna have been facing the downside of their pandemic success, as falling sales have brought tough questions from investors.Moderna, for its part, aims to follow its COVID shot with several other messenger RNA-based vaccines, including one for respiratory syncytial virus thats now under FDA review.Respiratory syncytial virus, or RSV, can cause severe illnessin infants, older adults and people with compromised immune systems. Two vaccines, from GSK and Pfizer, are already approved to prevent RSV-related disease in adults over the age of 60. Sales of each have been strong, although GSK has established a clear edge.Moderna argues its vaccine, dubbed mRNA-1345, can compete. The shot is a pre-filled, single-dose vaccine, potentially offering more convenient administration.In Phase 3 testing, the vaccine was 84% effective at preventing infection with two or more symptoms in older adults. That efficacy does appear to wane over time, however.At a recent meeting, Centers for Disease Control and Prevention advisers reviewed known safety risks for GSKs and Pfizers shots, both of which were associated in very rare cases with Guillain-Barr syndrome, or GBS, a neurological condition affecting the nerves. Moderna has not reported any cases of GBS in Phase 3 testing of its shot.An FDA decision on mRNA-1345 is set for May 12. Delilah AlvaradoGerons imetelstat for myelodysplastic syndromesDrug development is a time-consuming, expensive process. Geron, a biotech founded 34 years ago to pursue stem cell research, knows this well.The companys long journey may finally reach an end by June 16, when the FDA will decide whether to approve a bone marrow disease drug Geron has been developing for nearly two decades. Called imetelstat, the drug treats myelodysplastic syndromes and some analysts believe it has blockbuster potential.Over the many years of Gerons research, imetelstat failed studies in multiple cancer types, and the company lost Johnson & Johnson as a partner along the way. But the drug finally succeeded in Phase 3 testing for myelodysplastic syndromes last year. And in March, it secured the endorsement of an FDA advisory panel despite skepticism from agency reviewers.Geron aims to challenge Bristol Myers Squibbs Reblozyl, first with a clearance in people with lower-risk disease and then in more people who have the condition. Stifel analyst Stephen Wiley estimated the drug could generate $2 billion in peak yearly sales, as it could be helpful in people who dont respond well to Reblozyl.Geron could be a buyout target, too, according to Wiley, though the company has said it plans to sell the drug on its own. Ben FidlerSanofi and Regenerons Dupixent for COPDDupixent is one of the pharmaceutical industrys most widely used and lucrative products. Approved for asthma, eczema and three other inflammatory conditions, the drug earned the companies more than $11 billion in sales last year.By June 27, the FDA could add another major indication to Dupixents list of approved uses. The regulator is currently reviewing the injectable medicine as a treatment for a type of chronic obstructive pulmonary disease, or COPD.If cleared by the FDA, Dupixent would be the first biologic drug for people with moderate-to-severe COPD who also have evidence of whats called Type 2 inflammation. A pair of late-stage studies, which enrolled nearly 1,900 people, showed Dupixent could cut the rate of COPD attacks by about one-third. Analysts therefore expect the FDA to issue an approval and forecast billions of dollars in additional yearly sales. Ned PagliaruloPfizers gene therapy for hemophilia BSome time during the second quarter, the FDA will decide whether to clear a gene therapy from Pfizer for hemophilia B, the less common form of the blood clotting disorder.Reaching this point has been a long time coming for Pfizer, which licensed the therapy from Spark Therapeutics a decade ago. In subsequent testing, treatmentlowered bleeding rates and reduced the need for regular blood transfusions powerful benefits meant to last many years with a single infusion.But its unclear whether Pfizer will find a market if the FDA chooses to approve its therapy. A rival genetic medicine, from CSL Behring and UniQure, won U.S. approval for hemophilia B in November 2022. However, few patients have been treated to date, sluggish uptake that could reflect the breadth of effective options available.The story is similar with Roctavian, a gene therapy BioMarin Pharmaceutical sells for the more common A form of hemophilia. Only three patients received Roctavian last year: two in Germany and one in the U.S.Pfizers therapy, which in January won Canadian approval, could provide another data point. But the company seems to be downplaying its potential. In recent presentations for investors, a once-weekly shot called marstacimab has gotten higher billing. Ned Pagliarulo '

Given that Medicaid and CHIP cover a significant portion of all pregnancies in America—especially for historically disadvantaged groups—policy actions could play a key role in supporting vaccine access and health equity. As public health officials nationwide sound the alarm on a “tripledemic”—the emergence of the respiratory syncytial virus (RSV), the influenza virus and the COVID-19 virus simultaneously—pregnant women should take steps to protect themselves and their infants against infection. While cases of RSV in particular continue to climb, a new prenatal vaccine can reduce the risk of RSV-caused hospitalization by 60% if taken during the third trimester of pregnancy. However, during the 2022 flu season, only one out of four pregnant women received the prenatal vaccines recommended by the Centers for Disease Control and Prevention.   There are also troubling disparities in vaccination rates. Pregnant women with private health insurance are 74% more likely to receive recommended prenatal vaccines than pregnant women covered by Medicaid and the Children’s Health Insurance Program (CHIP), which provide healthcare coverage for low- and middle-income populations. This is a significant health equity issue: Medicaid and CHIP cover more than four out of 10 of all births in America (PDF), and approximately seven out of 10 births for pregnant women who are Black, American Indian, or Alaska Native—groups that experience severe and persistent disparities in maternal and infant outcomes. Improving vaccination rates in Medicaid will help improve vaccination rates for historically underrepresented groups. Making it easier for pregnant women to access vaccines—such as during a regular prenatal visit or at a community pharmacy—is one way to enhance vaccine uptake. Below, we recommend changes states can make to their Medicaid and CHIP policies to support access to prenatal vaccines in these settings. Our recommendations are informed by a recent study of Medicaid and CHIP policies in all 50 states, plus Washington, D.C., and Puerto Rico. The study was conducted by Manatt Health and supported by Pfizer, which manufactures prenatal and other vaccines (Editor’s note: Pfister and Polaris are co-authors of the white paper study.) Ensure adequate reimbursement for administering prenatal vaccines   First, states should ensure that physicians and other providers who administer prenatal vaccines receive adequate reimbursement. Providers incur a range of costs to acquire, store and administer vaccines, but state Medicaid programs don’t always adequately reimburse for these costs. The Manatt study found that many state Medicaid programs pay physicians less for the vaccines themselves than Medicare does.  In addition, most state Medicaid programs pay less than half the Medicare rate for adult vaccine administration, including nine that don’t pay a vaccine administration fee at all. As a result, in some states, Medicaid providers lose money (PDF) with every shot they administer. Evidence (PDF) shows that vaccine access for Medicaid beneficiaries improves when states close the reimbursement gap between Medicaid and other payers. Ensure pharmacies are properly incentivized to offer prenatal vaccines   Second, states should ensure that their Medicaid policies encourage pharmacies to offer prenatal vaccines.  As compared to physician offices, community pharmacies are located in more places and are more likely to be open outside regular business hours.  In addition, unlike most physician offices, community pharmacies generally offer vaccines on a walk-in basis. Unfortunately, the Manatt study found that in some states, pharmacists aren’t eligible to bill Medicaid for certain vaccines. And even when they are, states vary widely in their payment rates for pharmacist vaccinations. Ensuring that pharmacists are eligible to bill Medicaid for vaccines and that they are adequately reimbursed for doing so would help increase vaccine access. Ensure that the Vaccines for Children (VFC) program does not create barriers to vaccinations for pregnant youth   Third, states should make it easier to access vaccines through the federal VFC program. The VFC program distributes vaccines free of charge to state-certified providers for administration to youth enrolled in Medicaid (among others). In some states, only VFC providers are eligible to bill Medicaid for administering pediatric vaccines. However, compared to pediatricians, OB-GYNs and pharmacies are less likely to participate in VFC because of the administrative costs of participation, their relatively low volume of pediatric vaccines and states’ relatively low reimbursement for vaccinations. Given that four out of five (PDF) pregnant adolescents are covered by Medicaid, states should consider allowing OB-GYNs and pharmacies to bill for prenatal vaccines without enrolling in the VFC program, thereby enabling pregnant adolescents convenient access to those vaccines during their prenatal visits or at a pharmacy. Leverage managed care organizations   Fourth, states should consider opportunities to leverage managed care organizations—private health plans that contract with states to administer coverage and that now cover the vast majority of non-elderly Medicaid and CHIP enrollees. States can direct managed care plans to provide appropriate reimbursement for both vaccines and vaccine administration, as described above. In addition, states can require managed care plans to conduct member outreach and education on prenatal vaccines as part of care coordination for pregnant enrollees and can also define quality measures and financial incentives for their plans related to prenatal vaccination outreach and uptake. Address vaccine hesitancy   Finally, although we focus here on vaccine access, we should also be mindful that some individuals have concerns or uncertainty about receiving vaccines (prenatal or otherwise). Research shows that prenatal vaccine hesitancy reflects a combination of factors such as lack of healthcare access, cultural attitudes and beliefs, health literacy, trust in healthcare providers and racial discrimination. Thus, states should pair the access-focused strategies above with strategies to support public awareness and education regarding prenatal vaccinations, including local public service announcements as well as targeted and culturally competent outreach. Prenatal vaccines play a vital role in promoting healthy pregnancies and healthy babies. Given that Medicaid and CHIP cover a significant portion of all pregnancies in America—especially for historically disadvantaged groups—the policy actions described above could play a key role in supporting vaccine access and health equity. Elizabeth Cherot, M.D. is president and CEO of March of Dimes. Helen Pfister and Julian Polaris are partners in Manatt Health, the legal and consulting healthcare group of professional services firm Manatt, Phelps & Phillips, LLP. 

DUBLIN, March 29, 2024 /PRNewswire/ -- The "Syndromic Multiplex Panels Markets. Strategies and Trends. Forecasts by Syndrome (Respiratory, Sepsis, GI etc.) by Place, by Product and by Country. With Market Analysis and Executive Guides. 2024 to 2028" report has been added to ResearchAndMarkets.com's offering. Infectious disease Dx is changing and will change more in the future. Can a rapidly growing market expand even faster? Find out all about it in this comprehensive report on Syndromic Multiplex Diagnostics. Are targeted tests for specific pathogens going to be obsolete? Will diagnostics replace physicians? Will Infectious Disease testing move into the Physician's Office or even the Home? Learn about this market including the issues and outlooks. The two key trends of Point of Care Testing and Molecular Diagnostics are merging with spectacular success. It could possibly displace most frontline test protocols AND save money at the same time. The report forecasts the market size for five years and even further with a later updated report with next years numbers. Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 1.2 Guide for Executives and Marketing Staff 1.3 Guide for Investment Analysts and Management Consultants 2 Introduction and Market Definition 2.1 What are Syndromic Multiplex Tests? 2.2 Syndromic Testing - the quiet revolution in diagnostics 2.2.1 Syndromic Testing - more than Panels. 2.3 Market Definition 2.4 Methodology 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 3 Infectious Disease 3.1 Infections - The Big Picture 3.2 The Pathogens 3.2.1 Bacteria 3.2.2 Fungi and Protozoa 3.2.3 Viruses 3.2.4 Prions 3.3 Symptoms and Syndromes 3.3.1 Bacterial or viral 3.3.2 Typical Viral Symptoms 3.3.3 Typical Bacterial Symptoms 3.4 Disease 3.5 Transmission 3.6 Infectious Disease Diagnostics 3.6.1 Microbial culture 3.6.2 Microscopy 3.6.3 Biochemical tests 3.6.4 PCR-based diagnostics 3.6.5 Metagenomic sequencing 3.7 Defining Infections 3.8 Syndromic Infection 4 Industry Overview 4.1 Players in a Dynamic Market 4.1.1 Academic Research Lab 4.1.2 Diagnostic Test Developer 4.1.3 Instrumentation Supplier 4.1.4 Chemical/Reagent Supplier 4.1.5 Pathology Supplier 4.1.6 Independent Clinical Laboratory 4.1.7 Public National/regional Laboratory 4.1.8 Hospital Laboratory 4.1.9 Physicians Office Lab (POLS) 4.1.10 Audit Body 4.1.11 Certification Body 4.2 The Clinical Laboratory Market Segments 4.2.1 Traditional Market Segmentation 4.2.2 Laboratory Focus and Segmentation 4.2.3 Segmenting the Syndromic Testing Market 4.3 Industry Structure 4.3.1 Hospital Testing Share 4.3.2 Economies of Scale 4.3.2.1 Hospital vs. Central Lab 4.3.3 Physician Office Lab's 4.3.4 Physician's and POCT 5 Market Trends 5.1 Factors Driving Growth 5.1.1 Speed of Diagnosis. 5.1.2 Effect of Syndromic Testing on Costs. 5.1.3 Point of Care Advantage. 5.1.4 Accuracy and Diagnostic Risk. 5.1.5 Single Visits. 5.1.6 Improvement in Outcomes. 5.1.7 Impact of the Pandemic. 5.2 Factors Limiting Growth 5.2.1 Lower Prices. 5.2.2 Administration/reimbursement. 5.2.3 Infectious Disease is Declining But.. 5.2.4 Wellness Hurts. 5.2.5 Economic Growth improves Living Standards. 5.2.6 Impact of the Pandemic 5.3 Instrumentation, Automation and Diagnostic Trends 5.3.1 Traditional Automation and Centralization 5.3.2 The New Automation, Decentralization and Point of Care 5.3.3 Instruments Key to Market Share 5.3.4 Bioinformatics Plays a Role 5.3.5 PCR Takes Command 5.3.6 Next Generation Sequencing Fuels a Revolution 5.3.7 NGS Impact on Pricing 5.3.8 Whole Genome Sequencing, A Brave New World 5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 5.3.10 Comparing Syndrome and Targeted Testing 5.3.11 The Multiplex Paradigm Shift 5.3.12 The Sepsis Testing Market - Bellwether for Syndromics 5.3.13 The Single Visit and AntiMicrobial Resistance 5.3.14 Syndromics drives POCT adoption. 6 Syndromic Testing Recent Developments 6.1 Recent Developments - Importance and How to Use This Section 6.1.1 Importance of These Developments 6.1.2 How to Use This Section 6.2 BioMerieux Submits Application for Respiratory, Sore Throat Panel 6.3 Sensible Diagnostics Nabs Award for Respiratory Panel 6.4 Aptitude Medical Systems to Develop At-Home STI Test 6.5 Multiplex Meningitis/Encephalitis Panel Market Expanding 6.6 Burst Dx to Deliver Lab-Accurate ELISA-in-a-Cartridge 6.7 OpGen Seeking Approval for UTI Panel 6.8 Altratech to Enter MDx, POC Space by Supplanting PCR 6.9 BIOFIRE Announces New SPOTFIRE System 6.10 Cambridge Nucleomics to Develop 'Nanobait' Tech 6.11 Takara Bio Developing Multiplex Panels 6.12 Rover Diagnostics Developing Optical Multiplex PCR 6.13 Nanopath Secures Funding to Develop POC Dx 6.14 Genetic Signatures Wins Public Health Wales Contract 6.15 Qiagen Looks to Long-Term Growth 6.16 LexaGene Gets Investment 6.17 Seegene Multiplex COVID-19/Flu/RSV Test Receives Approval 6.18 BforCure to Adapt Rapid PCR Platform for Cancer 6.19 Accelerated Growth for Decentralized Testing 6.20 QuantuMDx Developing Syndromic Panels for European Launch 6.21 Quidel Gains CE Mark for Savanna Analyzer, Respiratory Panel 6.22 QuantumDx Gets CE Mark for Rapid PoC PCR System 6.23 Bio-Rad Laboratories, Seegene Partner for MDx Development 6.24 Baebies to Expand Finder Platform 6.25 With Luminex Acquisition, DiaSorin to Broaden MDx Portfolio 6.26 Binx Health Targeting Clinics, DTC & OTC With STI Tests 6.27 Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV 6.28 Molzym, Fraunhofer Developing Rapid Sepsis Diagnostic 6.29 MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test 6.30 New Approach Involves Silicon-Based Test for Infectious Disease Screening 6.31 Scanogen's Portable Battery Operated Instrument for 90 Minute Multiplex Test 6.32 Qiagen sees NeuMoDx as Growth Vehicle 6.33 Torus Biosystems Developing Syndromic Test with 30-Minute Turnaround 6.34 Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests 6.35 BioMerieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA EAU 6.36 Infectious Disease Testing Firm Curative Acquires KorvaLabs 6.37 ChromaCode Raises Additional $10M 6.38 COVID-19 Patients Need Syndromic Testing 6.39 GenMark Diagnostics - New Respiratory Panel due in June 6.40 Qiagen Respiratory Panel with Coronavirus Targets Receives CE Mark 6.41 Exact Diagnostics launches respiratory panel control 6.42 bioMerieux submits enhanced BIOFIRE BCID2 Panel to FDA 7 Profiles of Key Syndromic Testing Companies 7.1 Abacus Diagnostica 7.2 Abbott Laboratories 7.3 Accelerate Diagnostics 7.4 Ador Diagnostics 7.5 ADT Biotech 7.6 Akonni Biosystems 7.7 Alveo Technologies 7.8 Antelope Dx 7.9 Applied BioCode 7.10 Aureum Diagnostics 7.11 Aus Diagnostics 7.12 Baebies 7.13 Beckman Coulter Diagnostics 7.14 Becton, Dickinson and Company 7.15 Binx Health 7.16 Biocartis 7.17 BioFire Diagnostics (bioMerieux) 7.18 bioMerieux Diagnostics 7.19 Bio-Rad Laboratories, Inc 7.20 Bosch Healthcare Solutions GmbH 7.21 Cepheid (Danaher) 7.22 Credo Diagnostics Biomedical 7.23 Cue Health 7.24 Curetis N.V./Curetis GmbH 7.25 Detect 7.26 Diagenode Diagnostics 7.27 Diasorin S.p.A. 7.28 Domus Diagnostics 7.29 Enzo Biochem 7.30 Eurofins Scientific 7.31 Fluxergy 7.32 Fusion Genomics. 7.33 Genetic Signatures 7.34 GenMark Dx (Roche) 7.35 Grip Molecular Technologies 7.36 Hibergene Diagnostics 7.37 Hologic 7.38 Immunexpress 7.39 Inflammatix 7.40 Invetech 7.41 Janssen Diagnostics 7.42 Karius 7.43 Lexagene 7.44 LightDeck Diagnostics 7.45 Lucira Health 7.46 Luminex Corp (DiaSorin) 7.47 Maxim Biomedical 7.48 Meridian Bioscience 7.49 Mesa Biotech (Thermo Fisher) 7.50 MicroGem 7.51 Millipore Sigma 7.52 Minute Molecular 7.53 Mobidiag (Hologic) 7.54 Molbio Diagnostics 7.55 Nanomix 7.56 Novel Microdevices 7.57 OnsiteGene 7.58 Operon 7.59 Oxford Nanopore Technologies 7.60 Panagene 7.61 Perkin Elmer 7.62 Primerdesign (Novacyt) 7.63 Prominex 7.64 Proof Diagnostics 7.65 Qiagen 7.66 QuantuMDx 7.67 QuidelOrtho 7.68 Roche Molecular Diagnostics 7.69 Saw Diagnostics 7.70 Scope Fluidics 7.71 Seegene 7.72 Siemens Healthineers 7.73 Sona Nanotech 7.74 SpeeDx 7.75 T2 Biosystems 7.76 Talis Biomedical 7.77 Thermo Fisher Scientific Inc. 7.78 Vela Diagnostics 7.79 Veramarx 7.80 Visby Medical 7.81 XCR Diagnostics 8 The Global Market for Syndromic Multiplex Diagnostics 8.1 Global Market Overview by Country 8.2 Global Market by Syndrome - Overview 8.3 Global Market by Place - Overview 8.4 Global Market by Product - Overview 9 Global Syndromic Multiplex Markets - By Syndrome 9.1 Respiratory 9.2 Gastrointestinal 9.3 Blood 9.4 Meningitis/Encephalitis 9.5 Sexually Transmitted Disease 9.6 Other Syndrome 10 Global MDx Infectious Disease Markets - by Place 10.1 Hospital Lab 10.2 Outpatient Lab 10.3 Point of Care 10.4 Other Place 11 Global MDx Infectious Disease Markets - by Product 11.1 Instruments 11.2 Cartridges 11.3 Reagents 11.4 Other Product 12 Appendices 12.1 United States Medicare System: Clinical Laboratory Fees Schedule 12.2 The Most Used IVD Assays 12.3 The Highest Grossing Assays For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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