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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.
Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.
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.
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.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.
The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
Politico notes that the Biden Administration has not yet nominated a permanent Food and Drug Administration commissioner.
Anthony Fauci also informed the World Health Organization executive board that the US would be joining the COVAX initiative, according to CNBC.
A new preprint suggests some SARS-CoV-2 variants could affect the effectiveness of current vaccines, the Associated Press reports.
In Nature this week: Australian lungfish provides details on the movement of vertebrate life from water to land, and more.