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

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.

The firm reported on Tuesday that its diagnostics revenues rose 6 percent from a year ago while its biopharma lab services revenues rose almost 2 percent.

With the certification from the NYS Clinical Laboratory Evaluation Program, the company said the test is now available throughout the US.

The firm said that its overall revenues rose 2 percent year over year and 4 percent on an organic basis with a smaller increase in its life sciences revenues.

The real-time PCR-based companion diagnostic test identifies patients eligible for treatment with Amgen's Vectibix (panitumumab).

The first $25 million tranche was funded at close and used to retire Exagen's existing term debt facility with Innovatus Capital Partners.

NEW YORK — Digital pathology firm Gestalt Diagnostics said on Monday that it has raised $7.5 million through a Series A financing round. The round was led by Cowles Ventures, TVF Funds, Inland Imaging ...

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.

SSID Group said that the assets acquired in the deal will complement its gastric health portfolio and let it offer a broader range of tests to US labs.

NEW YORK – Impacts from China's volume-based procurement program and other healthcare pricing reforms led to flat Q1 diagnostics revenues year over year for Roche, company executives said Thursday.