Babson Diagnostics Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test
June 25, 2020
Austin, Texas - Babson Diagnostics, a transformative diagnostic blood testing company, announced today that its SARS-CoV-2 IgG antibody test, Babson Diagnostics aC19G1, has received emergency use authorization (EUA) from the Food and Drug Administration (FDA). Babson Diagnostics aC19G1 is a COVID-19 serology test that enables the qualitative detection of IgG antibodies to SARS-CoV-2 with 100% sensitivity and 100% specificity. The test is designed to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior COVID-19 infection.
“Not only is serology a crucial tool for the research and understanding of COVID-19, we believe it will become an essential component of ongoing preventive medicine”
Eric Olson, Babson Founder & CEO
Babson—whose core, proprietary technology bridges the gap between accuracy and convenience in diagnostic blood testing—joins prestigious organizations such as New York’s Mount Sinai Laboratory and Wadsworth Center as one of only five clinical laboratories to receive an EUA for a COVID-19 serology test. The company is using its serology testing technology to serve Austin, Texas, and the U.S.
“Not only is serology a crucial tool for the research and understanding of COVID-19, we believe it will become an essential component of ongoing preventive medicine,” said Eric Olson, Babson’s founder and CEO. “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.”
The test was developed at Babson’s headquarters in Austin, Texas, where the company’s various diagnostic assays are developed and performed on high-throughput platforms.
“When COVID-19 hit the U.S. and eventually Austin, the Babson team was inspired to contribute to the fight against one of the largest threats to global health in generations,” said Chris DiPasquale, director of assay development for Babson. “While launching the aC19G1 test has been a significant achievement for Babson, it is only the first step in supporting long-term public health and national security. Our R&D team currently has several projects in the pipeline to expand diagnostic capabilities for COVID-19 management and help combat future pandemics.”
Babson launched its IgG antibody test on April 30, 2020. The Babson Diagnostics aC19G1 test has been offered free-of-charge to essential front-line pharmacy and grocery workforces, and is currently in use in clinical studies with leading research centers such as Dell Medical School at The University of Texas at Austin.
Developing accurate and accessible serology testing underscores Babson’s mission to improve customers’ health by making diagnostic blood testing more convenient and human.
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.
About Babson Diagnostics
Babson Diagnostics is a healthcare technology company focused on moving laboratory testing to the pharmacy counter. Babson has developed a model for diagnostic blood testing that maintains a high standard of accuracy, yet requires only one-tenth the sample size of traditional venipuncture methods.