FDA Watch

SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals

Key new U.S. Food and Drug Administration product approvals announced from mid-February 2020 through March 20, 2020 include emergency use authorization (EUA) for eight different commercial tests for qualitative detection of the SARS-CoV-2 virus in patients showing symptoms of or suspected of having coronavirus:

NEW FDA APPROVALS

Manufacturer(s) Product(s)
Roche EUA for Cobas SARS-CoV-2 Test for qualitative detection
Thermo Fisher Scientific EUA for TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid
Hologic EUA for Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion system
Quidel EUA for Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2
Abbott EUA for Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System
Quest Diagnostics EUA for SARS-CoV-2 rRT PCR test
GenMark Diagnostics EUA for ePlex SARS-CoV-2 Test run on firm’s sample-to-answer ePlex system
DiaSorin Molecular EUA for Simplexa COVID-19 Direct assay run on firm’s sample-to-answer Liason MDX real-time PCR instrument
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, potassium, chloride and blood urea nitrogen
Siemens Healthineers Clearance for Advia Centaur BR assay to measure cancer antigen CA 27.29 using the Advia Centaur systems
BioMérieux Clearance for marketing Vitek 2 AST-GN Polymyxin B quantitative assay for antimicrobial susceptibility testing of Gram-negative bacilli
ARK Diagnostics Clearance for ARK Fentanyl II immunoassay to measure fentanyl in human urine at a cutoff concentration of 1.0 ng/mL on automated clinical chemistry lab analyzers
Ortho Clinical Diagnostics 510(k) clearance for Vitros BRAHMS procalcitonin assay to identify bacterial infections
Kurin Clearance for novel push-button needle
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