Austin, Texas - Babson Diagnostics, a transformative diagnostic blood testing company, announced today it has entered into a collaborative research agreement with Dell Medical School at The University of Texas at Austin (Dell Med) to study the immune response to COVID-19. The announcement follows the recent launch of Babson’s IgG serology test, which yielded 93.2 percent sensitivity and 100.0 percent specificity in its clinical performance evaluation and has been submitted to the FDA for Emergency Use Authorization.
“We still have so much to learn and discover about this virus. Collaborating with pioneering institutions like Dell Medical School will enable Babson to significantly advance our collective understanding of the virus, fueling research and development on the next generation of diagnostic and therapeutic technologies.”
Eric Olson, Babson Founder & CEO
The longitudinal research study is designed to measure the adaptive immune response to SARS-CoV-2 by following individuals over a two-year period. The initial phase of the study begins with 200 COVID-19 positive individuals, including patients and health care workers from UT Health Austin, the clinical practice of Dell Med. Babson will provide serology testing services as part of the collaboration. The research is designed to inform the diagnosis and treatment of COVID-19 infections as well as guide the allocation of critical medical resources.
“This research marks a vital step forward in understanding and managing COVID-19,” said Esther Melamed, M.D., Ph.D., neuroimmunologist, assistant professor in the department of neurology at Dell Med and principal investigator for the study. “Accurate testing for SARS-CoV-2 antibodies and a deeper understanding of the evolving adaptive immune response will help identify risk factors for COVID-19 disease severity and recovery, and will lead toward the next steps of identifying convalescent serum donors to treat the critically ill and developing protective vaccines.”
“Collaborative initiatives like this one help to advance Dell Med’s goal of accelerating the pace of research so that the community can benefit as quickly as possible from innovative health solutions,” said Stephen Strakowski, M.D., vice dean of research at Dell Med.
Babson’s pipeline of fully automated serology assays are heterogeneous immunoassays analyzed on high-throughput commercial analyzers in the company’s CLIA-certified, CAP-accredited, high-complexity clinical laboratory located in Austin.
“Researching and understanding the immune response to COVID-19 is essentially new science,” said Eric Olson, Babson’s founder and CEO. “We still have so much to learn and discover about this virus. Collaborating with pioneering institutions like Dell Medical School will enable Babson to significantly advance our collective understanding of the virus, fueling research and development on the next generation of diagnostic and therapeutic technologies.”
The research initiative is a continuation of the collaborative relationship Babson and Dell Med have maintained since Babson became one of the first companies to take up residence within Dell Med’s WorkSpaces, part of the Texas Health CoLab, a center for health product innovation entrepreneurship aligned with the medical school’s mission.
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;
and, - 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.