The test measures a protein biomarker and can be used to diagnose and manage patients with the progressive autoimmune disorder.

NEW YORK – Former Magellan Diagnostics CEO Amy Winslow pleaded guilty to violating the Food, Drug and Cosmetic Act in a case related to the malfunctioning of Magellan's lead-testing devices.

NEW YORK – Danaher subsidiary Beckman Coulter Diagnostics announced on Monday that its integrated clinical chemistry and immunoassay analyzer has received 510 (k) clearance from the US Food and Drug ...

Founded in 2009, CLIA-certified Pathline, which also holds College of American Pathologists and New York State Department of Health certifications, provides a range of lab services, including ...

Such tests are increasingly moving beyond their origins in cutting-edge research and into the laboratory and diagnostic ...

Last week, readers were most interested in a story about a lawsuit brought forth by Qiagen against BioMérieux in Germany.

According to the government, lab marketing firms arranged with healthcare providers to steer test referrals to a South Carolina lab in exchange for kickbacks.

The firm laid off all of its employees last month and inked agreements with top executives for part-time consulting work.

Angsana specializes in molecular diagnostics and Pathnova specializes in serology and artificial intelligence.

Qiagen alleges that BioMérieux infringes a European patent that protects the company's QuantiFeron interferon-gamma release assay technology for latent TB detection.

NEW YORK – With the launch of a multi-center clinical trial, Canadian biotech firm Breathe BioMedical said that it is developing a breath-based test to help identify breast cancer in patients whose ...