The Simplexa COVID-19/Flu A/B  & RSV Direct Kit is used for the detection and differentiation of infections with SARS-CoV-2, flu A/B, and respiratory syncytial viruses.

The Dublin-based firm is developing an array of artificial intelligence-derived tools to improve the efficiency of its digital pathology outsourcing service.

NEW YORK — Tosoh Bioscience said on Thursday that it has received 510 (k) clearance from the US Food and Drug Administration for its automated HLC-723 GR01 glycohemoglobin A1c (HbA1c) analyzer.

Called the RESULTS Act, the bill would use a third-party database to set Medicare payment rates and would delay price cuts and data reporting scheduled for 2026.

The certification applies to Gradientech's Class B QuickMIC GN AST panel for Gram-negative bacteria, along with the entire diagnostic platform.

Medicare Part B data show that of the 20 CPT codes seeing the largest increase in payments from 2022 to 2024, all are for molecular- or sequencing-based tests.

The Netherlands-based company will develop a low-cost, rapid point-of-care test using its Visualization by Infrared PEptide Reaction (VIPER) technology.

The firm's full and mini gastrointestinal panel tests can now be used with fecal swab samples to detect pathogen nucleic acids.

The Colorado firm is expanding its partnerships, outreach efforts, technology applications, and sales force for its oncology screening and monitoring test business.

The projects include the development of rapid diagnostic tests for tuberculosis, Strongyloides stercoralis, and malaria.

The company's Dragonfly instrument uses a proprietary sample preparation method and isothermal amplification to diagnose a variety of infectious diseases.

The partners will begin with work on a cortisol biosensor that can be used for stress and metabolic health testing.