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 […]
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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