NEW YORK – Eight German associations are calling for changes to be made to the European In Vitro Diagnostics Regulation (IVDR ...

The proceeds will be used to launch a new diagnostic instrument, a breast cancer monitoring assay, and proprietary multiplex immunofluorescence reagent kits.

The company said that its test could overcome sensitivity issues with ultrasound and serum alpha-fetoprotein assays that are used to monitor at-risk patients.

The former True Health Diagnostics executives were accused of participating in a scheme that paid Texas physicians for blood test referrals.

Of the 30 companies on the list, 17 saw their stock prices decrease, 11 saw their share prices increase, and two had their stock prices remain flat.

NEW YORK – Uppsala University spinout Readily Diagnostics is using technology built off 30 years of research as the basis of a point-of-care, instrument-free test that would detect and differentiate ...

In one case, a firm is alleged to have improperly billed the COVID-19 Uninsured Program while in the other, a firm paid and received kickbacks for unnecessary genetic testing.

The firm raised a total of $13.5 million in its Series A equity financing round, which will go toward growing and advancing its neurodegenerative disease testing business.

The firm said that it slashed its GAAP EPS guidance and made a smaller cut to its non-GAAP EPS guidance in response to US tariffs and other geopolitical conditions.

NEW YORK — Octave Bioscience said on Tuesday that its Multiple Sclerosis Disease Activity (MSDA) test has received certification from the New York State Clinical Laboratory Evaluation Program. The ...