The test, which received FDA clearance in late 2017, runs in as little as 18 minutes.
The lab is located within Novogene's sequencing center at the Sacramento campus of the University of California, Davis.
The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.
The firm's Group A Strep test for use on its Sofia2 analyzer also received CLIA waiver from the agency.
The firm has secured NYS approval for its sequencing-based 32-gene Fertilome assay, which it originally launched in January.
Buzzfeed News reports that some of Orig3n's athletic ability tests are subject to US Clinical Laboratory Improvement Amendments rules.
The company's Hong Kong laboratory was established in 2010 and was accredited by the College of American Pathologists in 2013.
The firm plans to launch its first test from the lab, a mRNA-based noninvasive confirmatory lung diagnostic, by the end of this year.
The company combines screening of live, patient-derived tumor cells with DNA sequencing and data analysis to match individuals with optimal drug therapies.
With the new certification in hand, the company plans to expand its business in the US through its Pennsylvania-based subsidiary, B. Braun CeGaT.
23andMe is offering early customers re-testing on newer chips for a fee, Wired reports.
He Jiankui is no longer affiliated with Direct Genomics Biotechnology, the single molecule sequencing company he founded, Nikkei Asian Review reports.
Newsweek writes about the hopes for precision medicine in cancer, but also challenges getting it to patients.
In Genome Research this week: genomic architecture of glioblastoma, predictive computational approach to estimate SNP fitness, and more.