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

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.

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

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 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 firm touted new assays, provided an update on its nanopore sequencer, and offered insights into upcoming pipeline ...

NEW YORK – Japan's Eiken Chemical, perhaps best known in the molecular biology space as the developer of the widely used loop-mediated isothermal nucleic acid amplification technology, has overhauled ...

NEW YORK – Molecular diagnostics firm Agendia, Knoxville Comprehensive Breast Center, and Knoxville Dermatopathology Laboratory have agreed to pay more than $3.75 million combined to resolve ...