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 […]
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, 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 |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE
| Manufacturer(s) | Product(s) |
| Euroimmun (part of PerkinElmer) | CE marking for Anti-SARS-CoV-2 ELISA tests for immunoglobulin classes A and G |
| Thermo Fisher Scientific | CE marking for COVID-19 diagnostic test |
| DiaCarta | CE marking for QuantiVirus SARS-CoV-2 test |
| AusDiagnostics | CE marking for multiplex PCR assay for SARS-CoV2, influenza and respiratory syncytial virus (RSV) |
| Vision Medicals | CE-IVD marking for SARS-CoV-2 Clinical Sequencing assay |
| 3D Medicine Science & Technology | CE marking for SARS-CoV-2 and Influenza A&B RT-qPCR detection kit |
| Qiagen | CE marking for QiaStat-Dx Respiratory SARS-CoV-2 Panel to detect and differentiate SARS-CoV-2 and 21 other respiratory pathogens |
| Credo Diagnostics Biomedical | CE marking for assay to detect SARS-CoV-2 |
| Genematrix | CE-IVD certification for Neoflex COVID-19 kit |
| CerTest BioTec | CE marking for ViaSure SARS-CoV-2 Real Time PCR Detection Kit |
| Genomica | CE marking for COVID-19 (SARS-CoV2) diagnostic kits |
| BGI | CE-IVD marking Real-Time Fluorescent RT-PCR kit for detecting SARS-CoV-2 |
| EliTech Group | CE marking for GeneFinder COVID-19 RealAmp kit |
| Snibe Diagnostic | CE marking for Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits |
| Co-Diagnostics | CE-IVD marking for Logix Smart Coronavirus COVID-19 |
| GenoScreen | CE-IVD marking for Deeplex Myc-TB kit for tuberculosis antibiotic susceptibility and resistance |
| DxTerity Diagnostics | CE marking for DxCollect at-home fingerstick blood collection device for RNA and DNA testing |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| Fosun Pharmaceutical | China | National Medical Products Administration emergency approval for SARS-CoV-2 detection kit |
| A*STAR and Tan Tock Seng Hospital | Singapore | Health Sciences Authority provisional approval for SARS-CoV-2 test |
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