The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.

The US Food and Drug Administration granted clearances for PCR-based infectious disease tests from multiple companies as well as other in vitro diagnostic tests.

InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.

The company beat analysts' average estimates on the top and bottom lines and guided to $7.3 billion to $7.4 billion in revenues for fiscal 2026.

The test is expected to be used by payors and healthcare systems to identify people most likely to respond to the weight-loss drugs.

Last week, readers were most interested in a story about a proposed acquisition by Abbott of Exact Sciences that would launch Abbott into the cancer testing space.

NEW YORK – Alzheimer's testing firm C2N Diagnostics said Monday that it has received a laboratory permit from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP).

PrognomiQ announced the initial launch of its ProVue blood test while Mercy presented new data detailing the performance of its Halo lung cancer test.

The firm's new strategy revolves around adding to its test menu in an impactful way and expanding its installed base of instruments.