ADLM Calls on HHS to reinstate CLIAC
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
Tag: HHS
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Affinity and Eurofins Conduct First COVID-19 Tests for Operation Expanded Testing
Eurofins Clinical Enterprise and Affinity Empowering, Inc. have conducted COVID testing for Operation Expanded Testing (OET) in Connecticut.
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TNG Dx to Develop Covid-19 Testing Protocols to Expedite Sample Processing
This new RNA extraction methodology may help clinical laboratories perform covid-19 analysis more quickly and more affordably.
HHS, DOD Invest $7.6M in Hologic to Expand Production for Covid-19 Tests
Under the contract, Hologic will expand production of custom sample collection and processing consumables for covid-19 tests.
Read MoreHHS Details New Covid-19 Testing Statistics Amid Test Volume Surge
More than 59 million covid-19 tests have now been completed nationally—averaging more 810,000 per day over the previous 7 days.
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Experts Identify Steps to Expand and Improve Antibody Tests in Covid-19 Response
The Covid-19 Serology Studies workshop has published a report of recommendations on covid-19 serology studies.
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HHS Issues Guidance on Laboratory Data Reporting for Covid-19 Testing
The guidance standardizes data reporting to ensure that public health officials have access to comprehensive and near real-time data to inform decisionmaking in their response to covid-19.
Read MoreMesa Biotech to Receive HHS Funding to Develop a 30-Minute Molecular POC SARS-CoV-2 Test
The Accula SARS-CoV-2 test will be developed for use on the company’s commercially available platform for Accula Flu A/Flu B and RSV test.
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DiaSorin Molecular Covid-19 Test Receives Emergency Use Authorization
The test is highly specific to covid-19 and targets several regions of the viral genome to minimize the impact on performance should there be possible future mutations.
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HHS Supports Development of High-Throughput Molecular Diagnostic for COVID-19
A COVID-19 diagnostic designed for use on a system that can process up to 1,000 tests in 24 hours will receive advanced development support from an HHS BARDA grant.
Read MoreHHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data
Final rules require access to health information, spur innovation, and aim to end information blocking.
Read MoreHHS Seeks Abstract Submissions for 2019-nCoV Diagnostics Development
The Biomedical Advanced Research and Development Authority will review submissions from organizations seeking to develop molecular diagnostics for 2019-nCoV.
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FDA Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic
Critical milestone reached in response to the Wuhan coronavirus outbreak.
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BARDA Funds HostDx Test Development
Inflammatix’s HostDx fever test reads the immune system to rapidly diagnose acute infections at the point of care.
Read MoreBeckman Coulter Receives BARDA Funding to Develop Early Sepsis Detection Algorithm
Beckman Coulter and Dascena will collaborate to develop and commercialize a novel machine-learning-based algorithm for the detection of sepsis.
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AAB Files Brief in Support of PAMA Lawsuit
The American Association of Bioanalysts has filed in support of the American Clinical Laboratory Association lawsuit challenging the Medicare fee schedule implemented in January under the Protecting Access to Medicare Act (PAMA).
Read MoreHHS Awards $5.1 Million to InBios to Advance Zika Diagnostic
Serological test may be able to return results in about 4 hours, and could be used in commercial and healthcare facility laboratories.
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OraSure Captures BARDA Contract for Ebola Test Development
The US Department of Health and Human Services has awarded a $10.4 million contract to OraSure Technologies for clinical development of the company’s OraQuick ebola rapid antigen test.
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