Roche test gains FDA emergency approval to identify COVID-19 patients at high risk of severe inflammatory response

Roche announced Thursday that the FDA issued emergency-use authorisation to its Elecsys IL-6 in vitro diagnostic test, with the immunoassay available on the company's cobas e analysers and able to provide results in around 18 minutes. Roche noted that the test measures levels of the biomarker interleukin 6 (IL-6) in serum or plasma and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of severe inflammatory response.

Thomas Schinecker, CEO of Roche's diagnostics unit, remarked "in the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus." The company added that the test, in combination with other examinations and vital signs, can help physicians decide early on if a patient with COVID-19 requires mechanical ventilation.

According to Roche, the IL-6 immunoassay is also used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation. Last month, Roche announced that the FDA authorised its Elecsys anti-SARS-CoV-2 antibody test for emergency use to help determine if a patient has been exposed to the virus that causes COVID-19 disease. The test also runs on the company's cobas e analysers.

Here is a non-exhaustive list of the regulatory status of some COVID-19 tests:

Company Test Status
Roche Diagnostics Elecsys IL-6 FDA EAU
Gravity Diagnostics Gravity Diagnostics COVID-19 Assay FDA EAU
Healgen Scientific COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) FDA EAU
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T) FDA EAU, CE mark
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T) FDA EAU, CE mark
PrivaPath Diagnostics LetsGetChecked Coronavirus (COVID-19) Test FDA EAU
dba SpectronRx Hymon SARS-CoV-2 Test Kit FDA EAU
BioCore BioCore 2019-nCoV Real Time PCR Kit FDA EAU
SolGent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit FDA EAU
Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit FDA EAU
P23 Labs P23 Labs TaqPath SARS-CoV-2 Assay FDA EAU
Everlywell Everlywell COVID-19 Test Home Collection Kit FDA EAU
Fulgent Therapeutics, Fulgent COVID-19 by RT-PCR Test FDA EAU
Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel FDA EAU
GeneMatrix NeoPlex COVID-19 Detection Kit FDA EAU
Applied DNA Sciences Linea COVID-19 Assay Kit FDA EAU
Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total FDA EAU, CE mark
1drop 1copy COVID-19 qPCR Multi Kit FDAEAU
Quidel Sofia 2 SARS Antigen FIA FDA EAU
Gnomegen Gnomegen COVID-19-RT-qPCR Detection Kit FDA EAU
Rutgers Clinical Genomics Lab Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay FDA EAU
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit FDA EAU
OPTI Medical Systems OPTI SARS-CoV-2 RT PCR Test FDA EAU
Sherlock BioSciences Sherlock CRISPR SARS-CoV-2 Kit FDA EAU
Biomerica COVID-19 IgG/IgM rapid test CE mark
Roche Diagnostics Elecsys Anti-SARS-CoV-2 FDA EAU
BioFire Diagnostics BioFire Respiratory Panel 2.1 (RP2.1) FDA EAU
Wadsworth Center, NYSDOH New York SARS-CoV Microsphere Immunoassay for Antibody Detection FDA EAU
QuantuMDX SARS-CoV-2 assay Launching in US; awaiting CE mark
LabGenomics LabGun COVID-10 RT-PCR kit FDA EUA
Rheonix Rheonix COVID-19 MDx assay FDA EUA
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab assay FDA EUA, CE mark
SEASUN Biomaterials U-TOP COVID-19 detection kit FDA EUA
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack FDA EAU
Autobio Diagnostics Anti-SARS-CoV-2 Rapid Test FDA EAU
Abbott SARS-CoV-2 IgG assay FDA EAU
SD Biosensor STANDARD M nCoV Real-Time Detection Kit FDA EUA
Zeus Scientific Lateral flow SARS-COV-2 IgG IgM test Launched in US
Trividia Health SARS-CoV-2 Antibody Test Kit Launched in US
Beckman Coulter Access SARS-CoV-2 IgG test In development
Gold Standard Diagnostics COVID-19 IgA, IgG, and IgM assays Launched in US
ThermoGenesis SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit Launched in US
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test Provisional Singapore HSA approval
FYR Diagnostics ALRT rapid COVID-19 test In development
Quidel Lyra DIRECT SARS-CoV-2 assay FDA EAU, CE mark
Biocartis Idylla SARS-CoV-2 test In development
MedMira Reveal COVID-10 total antibody test Launched in US
Seegene Allplex 2019-nCoV Assay FDA EUA
altona Diagnostics RealStar SARS-CoV02 RT-PCR Kits US FDA EUA
MobiDiag Novodiag COVID-19 assay Finland EUA, CE mark
LabCorp Pixel by LabCorp COVID-19 Test FDA EUA
Trax Management Services PhoenixDx 2019-CoV FDA EAU
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit FDA EAU
Fosun Pharma Fosun COVID-19 RT-PCR Detection Kit FDA EAU
KorvaLabs Curative-Korva SARS-Cov-2 Assay FDA EAU
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit FDA EAU
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test FDA EAU
Abbott SARS-CoV-2 IgG test FDA EAU
Chembio Diagnostic System DPP COVID-19 IgM/IgG System CE mark, FDA EUA
MobiDiag AmpliDiag COVID-19 test Finland EUA, CE mark
Atila Biosystesm iAMP COVID-19 Detection kit FDA EUA
DiaCarta QuantiVirus SARS-CoV-2 test kit FDA EUA
Becton Dickinson BD SARS-COv-2 reagents for BD MAX system FDA EUA
Biodesix SARS-CoV-2 Droplet Digital PCR Launched in US
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit FDA EUA
Gnomegen Gnomegen COVID-19 RT-Digital PCR Detection Kit FDA EUA
Biolidics Novel Coronavirus 2019 IgG/IgM test CE mark
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. FDA EUA
Menarini VitaPCR SARS-CoV-2 assay kit CE marked
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit FDA EUA
Co Diagnostics Logix Smart COVID-19 test FDA EUA, CE marked
BD, BioGX BioGX SARS-CoV-2 Reagents FDA EAU
Cellex qSARS-CoV-2 IgG/IgM Rapid Test FDA EUA
BD, BioMedomics COVID-19 antibody test Launched in US
Chembio DPP COVID-19 IgM/IgG System Launched in US
Bodysphere COVID-19 IgG/IgM Rapid Test Cassette Launched in US
Molecule Holding COVID Care COVID-19 IgG and IgM Rapid Test Launched in US
NeuMoDx Molecular, Inc. euMoDx SARS-CoV-2 Assay FDA EUA
Qiagen QIAstat-Dx Respiratory 2019-nCoV Panel FDA EUA, CE marked
Siemens Healthineers Fast Track Diagnostics SARS-CoV-2 test kit FDA EAU, CE mark
Luminex NxTAG CoV Extended Panel Assay FDA EUA
Sysmex 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit (BGI Genomics' test) Approved in Japan
Avellino AvellinoCoV2 test FDA EAU
Perkin Elmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit FDA EUA
Mesa Biotech Accula SARS-CoV-2 test FDA EAU
BioFire Defense (bioMerieux) BioFire COVID-19 test FDA EAU
Abbott RealTime SARS-CoV-2 assay FDA EUA
Quest Diagnostics Quest SARS-CoV-2 rRT-PCR FDA EUA
Quidel Lyra SARS-CoV-2 Assay FDA EUA
LabCorp COVID-19 T-PCR test FDA EAU
Hologic Panther Fusion SARS-COV-2 Assay FDA EUA
Centers for Disease Control and Prevention 2019-nCoV RT-PCR Diagnostic Panel FDA EUA
Wadsworth Center, NYSDOH New York SARS-CoV-2 RT-PCR Diagnostic Panel FDA EUA
Roche cobas SARS-CoV-2 FDA EUA
Thermo Fisher TaqPath COVID-19 Combo Kit FDA EUA
Fulgent/MedScan COVID-19 NGS Test Awaiting EUA
Diatherix Eurofins COVID-19 Panel Awaiting EUA
Stanford Medicine COVID-19 RT-PCR test In-house LDT
UC San Diego Health System COVID-19 Test In-house LDT
Diasorin Simplexa COVID-19 Direct Assay FDA EUA
Opko Health COVID-19 test In development
CerTest Biotec Viasure COVID-19 test CE marked
Genomica CLART COVID-19 test CE marked
Novacyt COVID-19 test FDA EUA, CE marked
BGI Genomics RT-PCR test CE marked, FDA EUA, Chinese NMPA approval
GenMark ePlex SARS_CoV-2 test FDA EUA
Cepheid Xpert Xpress SARS-CoV-2 FDA EUA
Aytu Biosciences COVID-19 IgG/IgM Rapid Test Awaiting FDA approval, CE marked
20/20 BioResponse CoronaCheck COVID-19 Rapid Antibody Test Kit Awaiting FDA approval
Corona Diagnostics Colloidal Gold COVID-19 POC screening test kit CE marked
Solgent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection assay CE marked/EUA in Korea, Philippines
Veredus Labs VereCoV MDx Singapore HSA provisional authorisation
CoSara Diagnostics RT-PCR COVID-19 test India CDSCO authorisation
Hologic Aptima SARS-CoV-2 FDA EUA

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