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...]
NPR Report
CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis
November 24, 2020
Top of the News
CDC Withdraws Recommendation of Testing for Asymptomatic Individuals After Close Exposure to COVID-19
September 22, 2020
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...]
Top of the News
Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing
September 3, 2020
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...]
Top of the News
Quest Test Gets First FDA Green Light for Sample Pooling to Detect SARS-CoV-2
August 4, 2020
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...]
Coronavirus
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
March 4, 2020
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...]
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
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...]
Industry Buzz
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
January 30, 2020
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...]
INDUSTRY TRENDS
Adoption Quickening for Genomic Cancer Testing in Community Settings
September 16, 2019
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...]
PUBLIC HEALTH
CDC Announces Shortage of TB Skin Test Antigen, New TB Testing Guidelines
August 12, 2019
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...]
INNOVATION
Multi-Cancer Screening Tests Are Getting Closer to Reality
July 15, 2019
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...]
