Dozens of New COVID-19 Tests Get Emergency Clearance in April
As of April 30, 69 COVID-19 assays have received Emergency Use Authorization (EUA) from the FDA, including seven serology tests, one saliva-based test and an at-home testing kit. What began as a trickle in February and March became a stream in April, with 50 approvals for COVID-19 approvals. The chart below lists just the commercial test products that got the green light during the month. Of course, there were also some significant new approvals for non-COVID-19 products. Here’s a summary of key new FDA and CE European clearances in April 2020. New FDA Emergency Use Authorizations (EUAs) & Approvals Manufacturer(s) Product Quidel Expanded EUA for Lyra SARS-CoV-2 assay BGI Americas (BGI Genomics US sub) EUA for BGI Real-Time Fluorescent RT-PCR Kit Luminex EUA for NxTag CoV Extended Panel Thermo Fisher Scientific Clearance for ImmunoCAP Specific IgE Stinging Insect Allergen Components for identifying insect sting sensitivity Roche Clearance for Cobas HPV test for human papillomavirus for use with its high-throughput Cobas 6800/8800 systems Qiagen EUA for QiaStat-Dx Respiratory SARS-CoV-2 Panel, first “syndromic” testing product to be deployed in US NeuMoDx EUA for NeuMoDx SARS-CoV-2 Test Strip for use on NeuMoDx 288 Molecular + NeuMoDx 96 Molecular systems Cellex EUA for qSARS-CoV-2 […]
As of April 30, 69 COVID-19 assays have received Emergency Use Authorization (EUA) from the FDA, including seven serology tests, one saliva-based test and an at-home testing kit. What began as a trickle in February and March became a stream in April, with 50 approvals for COVID-19 approvals. The chart below lists just the commercial test products that got the green light during the month.
Of course, there were also some significant new approvals for non-COVID-19 products. Here’s a summary of key new FDA and CE European clearances in April 2020.
New FDA Emergency Use Authorizations (EUAs) & Approvals
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE
Other international clearances announced during the period:
| Manufacturer(s) | Product |
| Quidel | Expanded EUA for Lyra SARS-CoV-2 assay |
| BGI Americas (BGI Genomics US sub) | EUA for BGI Real-Time Fluorescent RT-PCR Kit |
| Luminex | EUA for NxTag CoV Extended Panel |
| Thermo Fisher Scientific | Clearance for ImmunoCAP Specific IgE Stinging Insect Allergen Components for identifying insect sting sensitivity |
| Roche | Clearance for Cobas HPV test for human papillomavirus for use with its high-throughput Cobas 6800/8800 systems |
| Qiagen | EUA for QiaStat-Dx Respiratory SARS-CoV-2 Panel, first “syndromic” testing product to be deployed in US |
| NeuMoDx | EUA for NeuMoDx SARS-CoV-2 Test Strip for use on NeuMoDx 288 Molecular + NeuMoDx 96 Molecular systems |
| Cellex | EUA for qSARS-CoV-2 IgG/IgM Rapid Test, first coronavirus serology test to get EUA clearance |
| Ipsum Diagnostics | EUA for COV-19 IDx, an RT-PCR-based SARS-CoV-2 test |
| Sectra | 510(k) clearance for Sectra Digital Pathology Module for use in primary diagnostics |
| Becton Dickinson + BioGX | EUA for Sample-Ready hospital SARS-CoV-2 assay for use on BD Max system |
| Co-Diagnostics | EUA for Logix Smart Coronavirus COVID-19 Test |
| Luminex | EUA for Aries SARS-CoV-2 Assay |
| Gnomegen | EUA for COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2 |
| Becton Dickinson | EUA for BD MAX ExK TNA-3 kit run on BD Max system |
| InBios International | EUA for Smart Detect SARS-CoV-2 rRT-PCR Kit |
| DiaCarta | EUA for QuantiVirus PCR diagnostic (Dx) test for COVID-19 |
| Personal Genome Diagnostics | Clearance for its PGDx Elio Tissue Complete, NGS assay for genomic profiling of cancer |
| DNAe | Breakthrough Device designation for LiDia-SEQ platform and first assay |
| Atila Biosystems | EUA for iAMP COVID-19 Detection Kit |
| Specialty Diagnostic Laboratories | EUA for test for qualitative detection of a region in SARS-CoV-2 ORF1a/b gene |
| Orig3n | EUA for Novel Coronavirus Test for qualitative detection of two regions in SARS-CoV-2 nucleocapsid gene |
| Ortho Clinical Diagnostics | EUA for Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators serology test |
| Chembio Diagnostics | EUA for DPP COVID-19 serology point-of-care test and analyzer providing numerical readings for IgM and IgG antibody levels |
| Qiagen | Clearance for use of Therascreen BRAF V600E RGQ PCR kit as companion diagnostic to BRAF inhibitor encorafenib (Pfizer/Array BioPharma's Braftovi) |
| Incyte | Clearance for pemigatinib (Pemazyre) for previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements |
| GenoSensor | EUA for GS COVID-19 RT-PCR kit |
| Exact Sciences | EUA for SARS-CoV-2 RT-PCR test |
| Shanghai Fosun Pharmaceutical | EUA for COVID-19 RT-PCR test |
| Osang Healthcare | EUA for GeneFinder COVID-19 Plus RealAmp Kit |
| Trax Management Services | EUA for PCR-based SARS-CoV-2 test |
| Mobidiag | EUA for Novodiag PCR-based COVID-19 test |
| Seegene | EUA for PCR-based Allplex 2019-nCoV Assay |
| Abbott Laboratories | EUA for SARS-CoV-2 point-of-care test |
| Abbott Laboratories | EUA for SARS-CoV-2 IgG antibody serology test qualitatively detecting IgG antibodies |
| Abbott Laboratories | 510(k) clearance for Blue i-Stat CG4+ cartridge for use with venous and arterial whole blood samples |
| Altona Diagnostics | EUA for RealStar SARS-CoV-2 RT-PCR Kit US |
| SD Biosensor | EUA for Standard M nCoV Real-Time Detection kit |
| Ortho Clinical Diagnostics | EUA for SARS-CoV-2 immunoassay |
| Autobio Diagnostics | EUA for Anti-SARS-CoV-2 Rapid Test immunoassay |
| DiaSorin | EUA for Liaison SARS-CoV-2 S1/S2 IgG serology assay detecting IgG antibodies in people who’ve been infected |
| Agilent Technologies | Clearance for PD-L1 IHC 22C3 pharmDx as companion diagnostic for Merck’s pembrolizumab (Keytruda) on Dako Omnis platform |
| Manufacturer(s) | Product(s) |
| Biocept | CE-IVD marking for Target Selector EGFR mutation detection assay |
| Erba Mannheim | CE marking for announced Monday ErbaLisa COVID-19 ELISA kits for detecting IgG and IgM antibodies |
| Vela Diagnostics | CE-IVD marking for ViroKey SARS-CoV-2 RT-PCR Test |
| JN Medsys | CE-IVD marking for ProTect COVID-19 RT-qPCR kit to detect N1, N2 and N3 regions of SARS-CoV-2 |
| Eurofins Technologies | CE-IVD marking for three different ELISA-based serology tests for SARS-CoV-2 |
| Proteomics International Laboratories | CE marking for PromarkerD Immunoassay (IA) kit |
| PathoFinder | CE marking for RealAccurate Quadruplex Corona-plus PCR kit |
| Genetron Health | CE marking for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) Detection Kit |
| Beroni | CE marking for SARS-CoV-2 IgG/IgM Antibody Detection Kit |
| Genetic Signatures | CE marking for SARS-CoV-2 detection kit |
| Manufacturer(s) | Country(ies) | Product(s) |
| Rendu Biotechnology | China | National Medical Products Administration emergency approval for SARS-CoV-2 nucleic acid detection kit |
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