Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]
CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis
CDC Withdraws Recommendation of Testing for Asymptomatic Individuals After Close Exposure to COVID-19
The U.S. Centers for Disease Control and Prevention (CDC) raised eyebrows on Aug. 28 when it revised its COVID-19 testing guidance to suggest that testing is not necessarily a must for asymptomatic … [Read more...]
Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing
Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]
Quest Test Gets First FDA Green Light for Sample Pooling to Detect SARS-CoV-2
Things sure happen fast during a pandemic. While the U.S. Food and Drug Administration (FDA) has historically “encourage all test developers to reach out to [us] to discuss appropriate validation … [Read more...]
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
Adoption Quickening for Genomic Cancer Testing in Community Settings
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are lingering questions about the utility of results. These are the findings of several … [Read more...]
CDC Announces Shortage of TB Skin Test Antigen, New TB Testing Guidelines
The U.S. Centers for Disease Control and Prevention (CDC) announced a three-to 10-month national shortage of Aplisol (Par Pharmaceuticals; Chestnut Ridge, N.Y.), one of two purified-protein derivative … [Read more...]
Multi-Cancer Screening Tests Are Getting Closer to Reality
The hope of developing a single blood test capable of detecting multiple types of early-stage cancer is getting closer to becoming a reality. Two hopeful players, GRAIL (Menlo Park, Calif.) and Thrive … [Read more...]