Babson Diagnostics Gets FDA EUA Status for SARS-CoV-2 IgG Antibody Test

The aC19G1 serology test will allow to identify individuals with an adaptive immune response to SARS-CoV-2

Diagnostic blood testing company Babson Diagnostics has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG antibody test.

Babson’s aC19G1 is a Covid-19 serology test that facilitates the qualitative detection of IgG antibodies to SARS-CoV-2 with maximum sensitivity and specificity.

The serology test will help detect individuals with an adaptive immune response to SARS-CoV-2, demonstrating recent or prior Covid-19 infection.

Babson is said to join organisations such as New York’s Mount Sinai Laboratory and Wadsworth Center as one of only five clinical laboratories to secure a EUA status for a Covid-19 serology test.

The firm is providing its serology testing technology for the detection of Covid-19 patients in Austin, Texas, and the US.

Babson has developed the SARS-CoV-2 IgG antibody test at its headquarters in Austin

Babson has developed the Covid-19 test at its headquarters in Austin. It is also a place where the company developed various diagnostic assays and conducted on high-throughput platforms.

At present, the aC19G1 test is in use in clinical trials with research centres such as Dell Medical School at The University of Texas at Austin.

Babson Diagnostics founder and CEO Eric Olson said: “The early success of our assays, combined with our ongoing clinical studies and research partnerships, will provide pivotal insights into COVID-19 immunity and help us develop future generations of tests.

“Today’s research and development will also inform how other testing methods such as capillary blood collection can be used to ensure convenient and decentralized access to high-quality COVID-19 serology testing in the future.” –NSMedical