Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients

As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]


Lab industry leaders meet with White House on COVID-19 testing

The American Clinical Laboratory Association (ACLA) has issued a statement following a meeting last week with the White House's Coronavirus Task Force. Here is a statement from ACLA President Julie … [Read more...]


Two commercial labs testing now for COVID-19

Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]

CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing

On Feb. 6, CMS issued guidance to labs and other providers on how to use the newly approved Centers for Disease Control and Prevention (CDC) test for coronavirus. Here are the key takeaways. The … [Read more...]


Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests

The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a … [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...]


FDA Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

FDA Resounds the Alarm on Biotin Test Interference

In early November 2019, the FDA undated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning to lab … [Read more...]


New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]


LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]