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.

Mednax Inc. has inked a definitive agreement through which Radiology Partners will acquire the former's radiology solutions group for $885 million, with an eye toward creating a provider of comprehensive radiology and teleradiology services. El Segundo, Calif.-based Radiology Partners is a physician-owned, on-site radiology practice that partners with about 1,600 radiologists providing services to nearly 1,300 hospitals, clinics and imaging centers across 26 states. When the transaction wraps up, the combined organization, operated under the Radiology Partners name, will include more than 2,400 radiology physicians who provide services in every state plus Washington.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.

A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism.

PARIS – Novacyt SA has obtained CE marking approval for its polymerase chain reaction (PCR) respiratory virus test panel, Winterplex.

Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.

The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.