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

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

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.

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.

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.

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

With the permit, St. Louis-based C2N can offer its PrecivityAD2 and PrecivityAD Alzheimer's blood tests to patients in New York state.

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

The company presented data at last week's AMP annual meeting proving the concept of its platform's applications in infectious disease and cancer. The company's Protein Sciences segment saw revenues ...