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The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November. 

The company has started a clinical validation study for a PSA test running on the Claros 1 platform and expects to file for a PMA later this year.

House Democrats are seeking clarification on the impact of the White House's federal hiring freeze on FDA. 

Kits with the affected products may not be able to fully extract nucleic acids from samples and detect infection or provide a correct diagnosis.

In a letter to congressional leaders, the groups said they "believe strongly" that the FDA should play a critical role in developing a modernized framework.

At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.

The test can measure lower levels of troponin, enabling doctors to more accurately identify patients who actually have an acute myocardial infarction. 

The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs. 

The agency issued 510k) clearance to several of Siemens' products for use on the Sysmex CS2100i instrument.

Commenters told the FDA that antigen-based rapid influenza diagnostic tests have performed poorly, and the reclassification will "mitigate" health risks.