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

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

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 ...

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.

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.

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.

NEW YORK – With the UK launch of its combination PCR and immunoassay testicular cancer test last week, EDX Medical said that its test could improve the detection of early-stage cancers in young men as ...

NEW YORK – A US District Court's recent decision vacating the US Food and Drug Administration's final rule on laboratory-developed tests (LDTs) made clear that the agency does not have the legal ...

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.