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The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.
If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.
The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
The firm said its panel, which runs on its MDx-3000 system, tests nasopharyngeal swabs for the most common viruses and bacteria.
The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers.
The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.
In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.