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 […]
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 |