Biodesix unveils COVID-19 test that it says will cut false negatives

Biodesix announced Wednesday that it launched its SARS-CoV-2 Droplet Digital PCR (ddPCR) test for COVID-19 and will immediately submit the product for FDA emergency-use authorisation. CEO Scott Hutton remarked that "introducing the most sensitive test possible will aid in stopping the spread of the virus as it will reduce the number of false-negative test results."

Last month, Biodesix partnered with Bio-Rad Laboratories in a bid to advance a COVID-19 ddPCR test for US emergency use. The launch follows the publication of two studies demonstrating that ddPCR testing using Bio-Rad's QX200 system had superior sensitivity and precision for clinical detection of SARS-CoV-2, when compared to existing test methods performed using quantitative PCR. "The findings suggest that ddPCR testing can reduce false-negative results of COVID-19 without any increase to false-positive results and could be a powerful complement to the current standard of testing," Biodesix said.

According to Biodesix, its laboratory currently has the capacity to process 1000 COVID-19 tests per day and can provide results in 48 hours from the time it obtains the sample. Biodesix noted that it is initially receiving samples from local health systems, hospitals and clinics in Colorado, where the company is based.

Meanwhile, Bio-Rad recently announced the launch of its blood-based immunoassay kit to identify antibodies to SARS-CoV-2.

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

Company Test Status
Biodesix SARS-CoV-2 Droplet Digital PCR Launched in US
Bio-Rad COVID-19 serology test Launched in US
Diasorin COVID-19 serology test In development
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit FDA EAU
Gnomegen Gnomegen COVID-19 RT-Digital PCR Detection Kit FDA EAU
Biolidics Novel Coronavirus 2019 IgG/IgM test CE marked
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Awaiting 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 EAU
Co Diagnostics Logix Smart COVID-19 test FDA EUA; CE marked
BD, BioGX BioGX SARS-CoV-2 Reagents FDA EUA
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
Luminex NxTAG CoV Extended Panel Assay FDA EUA
Abbott ID NOW COVID-19 Test 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 EUA
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
BD/BioGX BD MAX COVID-19 Test FDA EUA
Co Diagnostics Logix Smart COVID-19 test Awaiting EUA; CE marked
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
Qiagen QIAstat-Dx Respiratory 2019-nCoV Panel CE marked
CerTest Biotec Viasure COVID-19 test CE marked
Genomica CLART COVID-19 test CE marked
Novacyt COVID-19 test CE marked, FDA EUA
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

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