Becton Dickinson, BioMedomics set for US roll out of COVID-19 test that can spot coronavirus exposure

Becton Dickinson and BioMedomics have unveiled a point-of-care serology test to detect blood antibodies that reveal current or past exposure to COVID-19 "in as little as 15 minutes." The test, developed and manufactured by BioMedomics, will be available in the US this month through Becton Dickinson and distributed exclusively by Henry Schein to healthcare providers across the country.

BioMedomics CEO Frank Wang said the test was designed "to be easy to use…with no special equipment necessary or the need to transport the sample to a laboratory for analysis." He added that the test has been clinically validated at several hospitals and clinical laboratories in both the US, as well as China, where "it has been used widely…during the COVID-19 outbreak." Dave Hickey, president of integrated diagnostic solutions at Becton Dickinson, noted that "initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19."

The companies said the test analyses blood, serum or plasma samples for the presence of IgM and IgG antibodies associated with SARS-CoV-2, while results can be read in a manner "similar to…over-the-counter pregnancy tests." However, they noted that current FDA guidance advises against using antibody testing results as the sole basis to diagnose or exclude coronavirus infection, and that additional testing should be considered.

Becton Dickinson and BioMedomics also said the test has not been reviewed by the FDA, but is permitted for distribution and use under the public health emergency guidance issued by the US regulator last month. Becton Dickinson added that it will "have capacity to supply more than 1 million tests over the coming months, with the ability to scale up based on market demand."

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

Company Test Status
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
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
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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