FDA finalizes guidance for validating in vitro diagnostic tests for emerging pathogens during declared public health ...

GeneDx plans to launch long-read whole genome sequencing for rare disease testing, with an early access program expected by ...

Ultima Genomics introduces paired-end sequencing and Solaris 2.0 Max consumables, enabling $60 genome and doubling output.

CDC reports early-season influenza activity is above average for November, with H1N1 dominating lab detections.

FDA clears bioMérieux’s VITEK PRO system for microbial identification and susceptibility testing, replacing VITEK 2 and XL.

Hoag researchers report a blood-based RNA marker that detects serous tubal intraepithelial carcinoma, a precursor to ovarian ...

Bio-Rad adds new ddPCR assays, reagents and technologies for QX700 systems, expanding multiplex cancer mutation and biomarker ...

FDA clears bioMérieux’s updated GI panels with redesigned norovirus assay and improved Campylobacter detection.

Labcorp has completed its acquisition of Millennium Health, expanding its national toxicology testing network.

FDA grants Breakthrough Device Designation to Primaa’s Cleo Skin AI pathology tool, which now has both CE-IVDR and FDA status ...

BillionToOne will launch Northstar Clear, a tissue-free MRD test for all solid tumors, on Dec 15, 2026, according to a ...

Hepta reports its AI-based blood test matched MRE in identifying treatment-eligible MASH fibrosis in an independent Madrigal ...