The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
A Bloomberg reporter tried to get her genetic data deleted, but found it's not so simple to do.
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.
The New York Times and ProPublica look into the close relationship between a startup and Memorial Sloan Kettering Cancer Center.
Yahoo News reports millions of dollars are being transferred from NIH, CDC, and other programs to pay for the housing of detained undocumented immigrant children.
In Science this week: in vitro generation of human reproductive cells, and more.
Researchers gave a handful of octopuses MDMA to find that they too act more social on the drug, Gizmodo reports.