The agency takes other steps to make COVID-19 tests more available.
FDA cleared two new coronavirus disease (COVID-19) tests via Emergency Use Authorization.
FDA Commissioner Stephen M. Hahn, MD, also outlined other ways the agency is working to get more tests available.
Related: Top 3 Things to Know About Coronavirus Treatments
The agency expedited approval of Panther Fusion SARS-COV-2 Assay (Hologic), and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
“Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency,” Hahn says in a press release. “Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January -- providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus.”
More than 40 labs have notified FDA that they are testing or intend to begin testing COVID-19 assays, Hahn added.
Related: FDA, FTC warn suppliers of fraudulent COVID-19 products
In addition, FDA’s new policy will allow states to take responsibility for tests developed and used by laboratories in their states.
“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” Hahn says in a separate press release.
FDA’s updated policy also provides recommendations for test developers that may wish to develop serological tests for use during the coronavirus outbreak.
“Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection. We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests…” Hahn says.
FDA has engaged with more than 100 test developers since the end of January, providing templates and advice about the Emergency Use Authorization process.
“More than 80 developers have sought our assistance with development and validation of tests they plan to bring through the EUA process. We’ve granted multiple diagnostic EUAs during this outbreak,” he says said.
Read more: More Ranitidine Recalled, Plus Another Big Drug Recall
In this second part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein spoke with Ceci Connolly and Margaret "Meg" Murray about Medicare Advantage utilization and challenges, highlighting proposed CMS payment cuts and prior authorization issues.
Listen
The Departments of Health and Human Services (HHS), Labor, and the Treasury, released final rules on short-term, limited-duration insurance (STLDI) and independent, non-coordinated excepted benefits coverage, addressing issues related to the low-quality insurance, or "junk insurance" plans.
Read More
In this first part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein kicks off our new podcast series "DC Roundtable," with guests Margaret "Meg" Murray, CEO of the Association of Community Affiliated Plans, and member of MHE's Editorial Advisory Board, and Ceci Connolly, president and CEO of the Alliance of Community Health Plans, for a discussion on healthcare policy issues.
Listen
2024 Emerging Leaders in Healthcare — Submit For a Chance to Be Featured in MHE's August Issue
March 28th 2024MHE Editors are seeking diverse healthcare professionals from different backgrounds and healthcare sectors, with individual interests. Eligible candidates are early or mid-career leaders with less than 10 years of experience. Award winners will enjoy complimentary passes to the PBMI Annual National Meeting in Orlando, Florida, from Sept. 4-6. Additional perks include a feature in our August issue, a subscription to MHE and more!
Read More
Muthiah “Muthu” Vaduganathan Discusses the Role of SGLT2 Inhibitors in Heart Failure Treatment
March 27th 2024Editors of Managed Healthcare Executive spoke with Muthiah “Muthu” Vaduganathan MD, MPH, consultant cardiologist at Brigham and Women's Hospital and a member of faculty at Harvard Medical School, about the evolving treatment landscape for heart failure, emphasizing the use of SGLT2 inhibitors alongside other foundational therapies.
Read More
In this second part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein spoke with Ceci Connolly and Margaret "Meg" Murray about Medicare Advantage utilization and challenges, highlighting proposed CMS payment cuts and prior authorization issues.
Listen
The Departments of Health and Human Services (HHS), Labor, and the Treasury, released final rules on short-term, limited-duration insurance (STLDI) and independent, non-coordinated excepted benefits coverage, addressing issues related to the low-quality insurance, or "junk insurance" plans.
Read More
In this first part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein kicks off our new podcast series "DC Roundtable," with guests Margaret "Meg" Murray, CEO of the Association of Community Affiliated Plans, and member of MHE's Editorial Advisory Board, and Ceci Connolly, president and CEO of the Alliance of Community Health Plans, for a discussion on healthcare policy issues.
Listen
2024 Emerging Leaders in Healthcare — Submit For a Chance to Be Featured in MHE's August Issue
March 28th 2024MHE Editors are seeking diverse healthcare professionals from different backgrounds and healthcare sectors, with individual interests. Eligible candidates are early or mid-career leaders with less than 10 years of experience. Award winners will enjoy complimentary passes to the PBMI Annual National Meeting in Orlando, Florida, from Sept. 4-6. Additional perks include a feature in our August issue, a subscription to MHE and more!
Read More
Muthiah “Muthu” Vaduganathan Discusses the Role of SGLT2 Inhibitors in Heart Failure Treatment
March 27th 2024Editors of Managed Healthcare Executive spoke with Muthiah “Muthu” Vaduganathan MD, MPH, consultant cardiologist at Brigham and Women's Hospital and a member of faculty at Harvard Medical School, about the evolving treatment landscape for heart failure, emphasizing the use of SGLT2 inhibitors alongside other foundational therapies.
Read More
2 Commerce Drive
Cranbury, NJ 08512