CLIA

The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.

The firm will scale US-based testing capacity for its LiquidHallmark liquid biopsy assay, which uses amplicon-based technology to detect cancer-related mutations.

The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.

The joint venture will establish CLIA labs within SG Blocks' shipping container-based structures, with an initial focus on SARS-CoV-2 testing.

The California-based genetic testing firm said its new lab will be able to process 20,000 tests per day and will initially focus on COVID-19 testing.

Under the clearance, capillary whole blood is no longer an acceptable sample type for the company's Blue i-Stat CG4+ cartridge.

The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.

The University of Utah spinout said it will use the funding to enhance and expand its NGS-based Explify microbe identification platform and support its lab.

The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.