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.

NEW YORK – Diagnostic companies saw their stock prices continue to decline in April, falling 4 percent after a 5 percent decline in March, and dipping even deeper than the broader market. The Top 30 ...

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.

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.

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 ...

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.

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.

Last week, readers were most interested in a story about Akoya's collaboration to identify markers predictive of response to checkpoint inhibitor therapy.

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