The PD-L1 IHC 22C3 PharmDx (Code SK006) assay is now certified for use to aid treatment decisions for patients with gastric or gastroesophageal junction adenocarcinoma.

The blood test detects a protein biomarker to aid in the diagnosis of axial spondyloarthritis, which is often mistaken for lower back pain.

The aggregate repurchase authorization program now totals $200 million, which the firm will fund with cash and cash equivalents.

VIENNA – Irish researchers presented data Saturday at the European Society of Clinical Microbiology and Infectious Diseases ...

The US Food and Drug Administration granted clearances for testing instruments, a blood clot drug companion diagnostic test, and infectious disease tests, among other devices.

NEW YORK — Abbott on Wednesday announced that its Q1 2025 Diagnostics revenues declined 7 percent year over year, while its total revenues grew 4 percent. For the three months ended March 31, Abbott ...

NanoSpeed Diagnostics announced Tuesday that it has obtained regulatory approval in Canada for a qualitative test to assess vitamin D in a fingertip blood sample at the point of care. The Test4D Serum ...

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

The firm is developing a kitted version of the four-biomarker combination test, and it plans to commercialize them in the EU and US markets.

Last week, readers were most interested in a story about Roche ramping up the commercialization of its sample self-collection devices for HPV.

The firm raised the money last week in a public offering of 14,375,000 common shares, and it will use the money for working capital and general corporate purposes.