The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
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.
Publication of He Jiankui's work on gene-edited infants would raise ethical concerns for journals, Wired and others report.
The New York Times reports that evidence linking trauma in one generation to epigenetic effects that influence subsequent generations may be overstated.
ScienceInsider reports that US National Institutes of Health researchers were told in the fall they could not obtain new human fetal tissue.
In PNAS this week: skin pigmentation evolution among KhoeSan, biomarkers for dengue virus progression, and more.