The Florida company's Kiffik K-Exp platform enables continuous access to interstitial fluid for longitudinal molecular diagnostic testing.

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.

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 assay is the first to receive FDA 510(k) clearance and CLIA waiver for use with Diasorin's Liaison Nes platform.