The Month in Global New Diagnostic Test Approvals

In addition to Emergency Use Authorization clearances for 15 COVID-19 tests, the FDA cleared a number of other non-coronavirus tests via its standard pathways. Here’s the rundown of key new approvals announced during March 2020. NEW FDA APPROVALS Manufacturer(s) Product(s) Life Technologies (Thermo Fisher Scientific) Clearance for Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer Magnolia Medical Technologies Clearance for expanded Steripath Gen2 Initial Specimen Diversion Device line of blood contamination reduction products Meridian Bioscience Clearance for Curian analyzer and Curian HpSA assay using immunofluorescent technology to detect Helicobacter pylori antigens in stool samples Roche Clearance for CINtec Plus Cytology test to assess risk of cervical cancer in women with HPV infections Roche Breakthrough device designation for Elecsys Galad score to diagnose early-stage hepatocellular carcinoma Roche Clearance for Cobas Influenza A/B and RSV nucleic acid test running on firm’s Cobas Liat Roche Clearance for Tina-quant C-Reactive Protein IV test for measuring C-reactive protein in serum and plasma on firm’s Cobas c systems MFB Fertility Clearance for Proov at-home progesterone ovulation test Abbott Clearances for i-Stat Chem8+ cartridge running on iStat 1 system for measuring: *Glucose and creatinine *Hematocrit (for determining total red cell volumes) *Sodium, […]