FDA Watch

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 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


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:


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


Other international clearances announced during the period:

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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