The Cologuard colorectal cancer screening test is the first product to make it through a new pilot program that offers parallel review of medical devices and diagnostics by both the Food and Drug Administration and the Centers for Medicare & Medicaid Services.
Biodesix recently announced the inclusion of its VeriStrat profiling test in updated evidence-based, consensus-driven NCCN Guidelines for managing non-small-cell lung cancer.
The Lab 7 Enterprise Sequencing Platform is a software solution that enables deep data provenance while streamlining routine operations for next-generation sequencing labs.
Under an FDA emergency use authorization, BioFire’s commercial BioThreat-E test for the ebola Zaire virus is now available to high- and moderate-complexity clinical laboratories in the United States.
The SE1-QB Bluetooth wireless 2-D barcode scanner from Denso ADC, Long Beach, Calif, is designed to serve as the front end of a mobile data-capture system consisting of a scanner and host smartphone or tablet.
BioTek has received a patent addressing the use of ultrasonic devices to check for clogged manifold tubes and to clean the manifold tubes of a microplate washer automatically. The features are available on the company’s 405 family of washers.
ARK Diagnostics and Roche have announced a partnership to integrate ARK’s methotrexate test into the Roche therapeutic drug monitoring menu for its Cobas C 501 and Cobas C 502 clinical chemistry analyzers.
A new line of analog stirring hot plates and stirrers from Torrey Pines Scientific features models with five or nine stirring positions and can support more than 50 pounds on the plate surface.
Vela Diagnostics, Singapore, has announced the availability of the Sentosa SQ Non-Small Cell Lung Cancer panel and the Sentosa Colorectal Cancer panel for next-generation sequencing-based detection of sequence variants, for research use only by early-access customers.
The DiaSpect hemoglobin analyzer from EKF Diagnostics, Boerne, Tex, is a palm-sized point-of-care analyzer suitable for use in all climate conditions. The plexiglass microcuvettes have a shelf-life of 2.5 years and can be stored from 0° to 50°C, requiring no refrigeration.