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

NEW YORK – NanoSpeed Diagnostics announced on 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 firm is developing a kitted version of the four-biomarker combination test, and it plans to commercialize them in the EU and US markets.

VIENNA – Irish researchers presented data Saturday at the European Society of Clinical Microbiology and Infectious Diseases global congress validating interleukin-6 as an early detection biomarker for ...

The purchase includes the manufacturing process of four ELISA kits, two of which are in vitro diagnostic products for specialty diagnostics and disease monitoring.

The Switzerland-based firm's MosaiQ AiPlex Connective Tissue Diseases (CTDplus) assay is used to aid the diagnosis of autoimmune diseases.

NEW YORK — ABL Diagnostics said on Wednesday that it has signed an agreement for the distribution of its infectious disease molecular assays in India with Genient Tech Private.

The firm's next-generation sequencing-based test detects single nucleotide variants, insertions, and deletions in 22 genes.

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

The firm said that it has received approval for a test that combines the Allsheng-developed Auto-Pure 2400 liquid handling platform with Revvity's T-SPOT.TB test.

VIENNA – Irish researchers presented data Saturday at the European Society of Clinical Microbiology and Infectious Diseases global congress validating interleukin-6 as an early detection biomarker for ...

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