Babson Diagnostics Launches COVID-19 Serology Test for IgG Antibodies with 100% Specificity in Austin
April 30, 2020
Austin, Texas — (BUSINESS WIRE) — Babson Diagnostics (Babson), a transformative diagnostic blood testing company, announced today it has launched its first COVID-19 serology test to detect IgG antibodies to SARS-CoV-2 in the bloodstream through a select network of retail and clinical partners in Austin, Texas. Clinical performance evaluation for Babson’s IgG assay resulted in 100 percent sensitivity and 100 percent specificity.
Babson is developing a pipeline of fully automated COVID-19 serology assays, including qualitative and quantitative measurement of the immune response across a number of sample types. Babson’s tests are high-throughput heterogeneous immunoassays analyzed at the company’s CLIA-certified, CAP-accredited, high-complexity clinical laboratory in Austin.
“We’re encouraged by the early success and performance of our initial IgG assay. Serology testing will be a critical measure for understanding COVID-19 and enabling frontline workers to continue to serve the community.”
“We’re encouraged by the early success and performance of our initial IgG assay,” said Eric Olson, Babson’s founder and CEO. “Serology testing will be a critical measure for understanding COVID-19 and enabling frontline workers to continue to serve the community. We project that our network of partners will enable us to scale our testing service to tens of thousands of tests per week, helping Austin’s health care community gain a new understanding of the virus’s impact on our city and surrounding areas.”
Babson plans to deploy thousands of tests to essential retail and clinical partners such as grocery stores and pharmacies as well as various health care and social services organizations. The first wave of tests will be delivered pro bono to participating organizations for frontline employees, providing trusted, high-quality serology testing in Austin and its surrounding areas to rapidly advance the understanding of COVID-19 and support Texas’ reopening strategy.
The following disclaimers apply:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA only for use by the authorized laboratory, Babson Diagnostics, Inc.
- This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.