The new test will also be packaged as a kit for routine diagnosis of HDV RNA and HBV DNA.
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The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.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 US Department of Justice has proposed a rule change to enable DNA to be collected from migrants, the Associated Press reports.
Bernard Fisher, a surgeon who changed how breast cancer is treated, has died at 101, the New York Times reports.
A Washington Post columnist writes that she is skeptical about DNA-based diets.
In PNAS this week: recurrent inactivation of DEPDC5 in gastrointestinal stromal tumors, taxonomic reliability of GenBank sequences, and more.