The firm will enter studies this month aimed at obtaining CLIA waiver for its FDA-cleared FebriDx assay to distinguish bacterial from non-bacterial infections.

Jeffrey Madison had been accused of participation in a scheme to pay kickbacks to physicians for testing referrals and billing healthcare programs for the tests.

The stool-based test is the next-generation version of Exact's existing Cologuard test for colorectal cancer screening.

The Alinity M MPXV test is a real-time PCR assay that detects monkeypox virus DNA from human skin lesion swabs.

The firm raised $7.5 million in its financing round and plans to use the money for further development of its platform and regulatory milestones.

The BARDA funding will support studies to validate the Melbourne, Australia-headquartered firm's flagship FebriDx rapid host-response respiratory infection test in low complexity settings and ...

The company was accused of billing the federal government for medically unnecessary urine drug tests and providing kickbacks to physicians.

The methods use heat to create bubbles that collect target particles. The bubbles leave behind concentrated deposits as they cool and shrink.

The solution will use Owkin's data network and artificial intelligence to prescreen for gBRCA mutations in breast cancer directly from digital pathology slides.

The company aims to streamline its own lab operations while also enabling distribution of its Alzheimer's tests to outside ...

Abionic received CE marking for the IVD Capsule PSP test in early 2017 and EU IVDR certification in mid-2022. The test is being developed for the Chinese market by Fapon under an exclusive license ...

Quanterix has launched its Simoa p-Tau 217 Planar Kit for measuring levels of the Alzheimer's biomarker ptau-217 in plasma. The RUO kit uses antibodies licensed from Eli Lilly and runs on Quanterix's ...