FDA Issues First EUA for At-Home, Non-Prescription Molecular COVID-19 Test

In a new first, molecular testing for COVID-19 can now be performed at home without a prescription, changing the COVID-19 testing market.
FDA Issues Alert for Clinical Laboratory Staff for Potential False Results with Roche COVID-19 Test

This alert identifies two issues and issues three recommendations.
Research Shows That Decoys Can be Effective in Neutralizing SARS-CoV-2

Use of this technology could be preventive, administered to people before they have an infection, says Rensselaer professor.
CMS Issues Guidance to Reduce Commercial Payer Denials for COVID-19 Testing

Centers for Medicare and Medicaid Services (CMS) makes at least eight key points about commercial payer coverage related to COVID-19 testing and vaccination.
Revenue Experts Give Insights Into How Clinical Laboratories Should Plan for the Future

A sustained drop in COVID-19 diagnostic testing could present the clinical laboratory industry with opportunities, but it could also lead to potential damages if not handled proactively and correctly.
Life After COVID: Positioning Your Lab for Success in a Post-Pandemic World

Now available for streaming: How does your lab begin to prepare itself to succeed in a post-pandemic world? Start your plan now to navigate the transition. Attend this complimentary webinar and hear the ways in which your lab’s current testing can create assets for the future, and how you can best position your lab for success in a post-pandemic environment by leveraging your diagnostic data as a strategic asset.
FDA Issues EUA for NGS Test to Identify T Cell Immunity for COVID-19

While T-cell immunity is still a very active field of COVID-19 study, this new test now allows clinicians to offer T-cell COVID-19 testing for their patients.
FDA Changes Storage Requirements for Pfizer COVID-19 Vaccine, Facilitating Faster and More Widespread Use

New storage requirement for Pfizer vaccine makes it easier for clinical laboratory personnel to access vaccine.
FDA Issues New Guidance for Test Developers on How to Plan for Genetic Variants

Toward the performance of diagnostic tests, three main components are addressed by this new guidance.
Over $23 Million of COVID-19 Tests May Go to Waste in Hawaii as Large Volumes of Tests are Set to Expire

How the state plans to address potential waste of COVID-19 tests.