Sometime next month, FDA will publish a framework for the regulation of laboratory-developed tests, bringing an end to the agency’s long-held policy of “enforcement discretion.”
This issue’s Product Spotlight includes the CLC6410 analyzer from Carolina Liquid Chemistries, the Cobas 8000 analyzer series from Roche Diagnostics, and the Stat Profile Prime from Nova Biomedical.
A comprehensive NGS target enrichment solution offers simple and rapid workflow for detecting gene fusion events in oncology research and clinical testing.
A blood test for the early detection of lung cancer will soon be offered through standard clinical channels as well as directly to consumers.
Available for licensing, new patents further develop IP related to CD81 and human glucokinase.
The QK30 barcode scanner from Denso ADC is the only scanner in its class to offer programmable multicolored LEDs, play audio files, and enable remote device management via Denso’s interleaving media scanning technology.
AdvantaPure’s BioClosure container closures are manufactured from biopharmaceutical grade thermoplastic elastomer, providing weldability and helping eliminate the need for aseptic connectors.
The PD-L1 (SP142) rabbit monoclonal immunohistochemistry antibody from Spring Bioscience offers a sensitive and specific method to stain and analyze both tumor and immune cells.
The ESR-Auto Plus automated sed-rate analyzer from Streck measures the sedimentation rate of erythrocytes with a greater than 98% correlation to the Modified Westergren method.
New CE mark in the European Union extends application of Ventana system to routine pathology, including primary diagnosis with human tissue specimens.