The Florida company's Kiffik K-Exp platform enables continuous access to interstitial fluid for longitudinal molecular diagnostic testing.
Last week, readers were most interested in a story about concerns among some clinicians around BillionToOne's Unity NIPT due to false negative results.
Readers this past year were most interested in a story about the FDA abandoning its plans to regulate LDTs after a court struck down its efforts.
The SD Biosensor Standard Q COVID-19 Ag Test and Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under WHO's emergency use listing.
The assay is the first to receive FDA 510(k) clearance and CLIA waiver for use with Diasorin's Liaison Nes platform.
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