Top of the News

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...]

Top of the News

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...]

Top of the News

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...]

Coronavirus

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...]

FDA Watch

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...]

Industry Buzz

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...]

INDUSTRY TRENDS

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...]

PUBLIC HEALTH

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...]

INNOVATION

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...]

INDUSTRY TRENDS

Consumers Interested in Raw Genetic Data, Third Party Interpretation Tools

Consumers of direct-to-consumer (DTC) genetic testing download raw data at high rates and frequently use third-party interpretation (TPI) tools, according to a study published June 13 in the American … [Read more...]


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