The firm has closed its CLIA lab in Minnesota and all functional operations of the former facility have been taken over by the new lab.
The firm's Dunedin, New Zealand lab can now process the Cxbladder Triage test on samples originating in the US. Pacific Edge also has a lab in Pennsylvania.
The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.
The test is the second to be waived for use on the Alere i isothermal nucleic acid amplification platform, and detects Group A Strep DNA in eight minutes or less.
With the certification, Resolution can offer its test to researchers and clinicians to help guide personalized therapies and direct patients into clinical trials.
The point-of-care Roche cobas Liat Strep A assay can now be run in physician's offices and pharmacy clinics.
The firm now has a license to perform clinical laboratory services.
The microbiome sequencing firm has analyzed millions of data points from a citizen science project to develop clinical assays.
The StrandAdvantage test currently analyzes 48 cancer-related genes on one of the laboratory's three Illumina MiSeq instruments.
The accreditation will help the company's facility move research findings more quickly into the clinical sphere.
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.