The Rural Health Transformation Program may be an unprecedented boon for healthcare, but diagnostics developers are running the risk of missing out.

NEW YORK – Roche announced on Wednesday that it has received US Food and Drug Administration approval for the expanded use of two companion diagnostic tests with Jazz Pharmaceuticals' Ziihera ...

The firm currently offers a multi-cancer detection test as an opt-in for patients receiving its Shield colorectal cancer screening assay.

The firms will integrate their technologies into a single workflow and jointly engage in initiatives to raise awareness of AI-based precision oncology testing.

The test is intended to support rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.

Last week, readers were most interested in a story about OraSure's withdrawal of an FDA submission and the cancellation of a milestone payment to Sherlock Biosciences.

The aim of the competition is to accelerate the creation of tests that enable early detection and diagnosis, particularly in less common cancers ...

NEW YORK – C2N Diagnostics said Thursday that its PrecivityAD2 Alzheimer's test has received 510(k) clearance from the US Food and Drug Administration. The mass spectrometry-based blood test is ...

NEW YORK – Avricore Health subsidiary HealthTab announced on Thursday that it has signed an agreement with Abbott to supply and distribute the firm's point-of-care testing products in the UK.

The firm recently raised $15 million in seed financing to further validate and commercialize its pathogen detection and antimicrobial resistance profiling platform.

There was a noticeable uptick in digital pathology devices and software clearances among more than a dozen 510(k)s granted by the agency last month.