The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.

The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.

The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.

A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.

The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.

An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”

Systematic detection of cancer at earlier stages at a population level could remodel how the medical profession approaches cancer treatment, establishing the potential to reduce cancer mortality by almost one-quarter. That’s according to an analysis based on the latest data from Grail Inc.'s Circulating Cell-free Genome Atlas (CCGA) study.

The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.

The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.