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.
The stool-based test is the next-generation version of Exact's existing Cologuard test for colorectal cancer screening.
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 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 company was accused of billing the federal government for medically unnecessary urine drug tests and providing kickbacks to physicians.
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 methods use heat to create bubbles that collect target particles. The bubbles leave behind concentrated deposits as they cool and shrink.
The Alinity M MPXV test is a real-time PCR assay that detects monkeypox virus DNA from human skin lesion swabs.
Less than one quarter of pathology labs have adopted whole-slide imaging so far, but pathologists and companies in the space ...
The tests will measure blood-based tau markers, offering a possible alternative to PET imaging for aiding in diagnosis and staging of Alzheimer's disease.
Within three years, the project anticipates at least one test for the early-stage detection of Alzheimer's disease could be ready for commercialization.
The solution will use Owkin's data network and artificial intelligence to prescreen for gBRCA mutations in breast cancer directly from digital pathology slides.