The agency accused the Germany-based firm of selling multiple saliva-based ELISAs without appropriate marketing authorizations, among other violations.

The deals cover development and commercialization of next-generation sequencing and digital PCR assays for minimal residual disease detection.

The BLIPI test device was used to monitor babies' immune status from a drop of whole blood and detected sepsis within 15 minutes, enabling incubator-side testing.

Of the 30 companies included in the list, 15 saw their stock prices decline, while 15 saw their share prices rise.

Northwestern Medical will begin using PathAI's AISight digital pathology image management system as part of the deal.

Last week, readers were most interested in a story about what's up Roche's sleeve as it talked about its plans during its investor day.

The RiskReveal assay was used to determine which early-stage non-squamous NSCLC patients should undergo adjuvant chemotherapy.

The team developed a tumor-independent test that is used to evaluate genome-wide cell-free DNA fragmentation profiles and repeat landscapes.

The company's flagship assay uses whole-genome sequencing to identify patients with high-risk multiple myeloma and determine which patients won't respond to therapies.

The envisioned flow cytometry test will help to predict patient response to immunotherapies for five cancer indications.

NEW YORK — Genedrive said Friday that it has received CE marking under the EU's In Vitro Diagnostic Medical Device Regulation (IVDR) for its point-of-care CYP2C19 ID Kit genotyping platform, which is ...