ThermoGenesis Announces that it has Notified the FDA of its Intent to Distribute the Company’s Rapid COVID-19 Point-of-Care Test Kit
RANCHO CORDOVA, Calif., March 31, 2020 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that it has notified the U.S. Food and Drug Administration (FDA) of its intent to distribute the Company’s SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit intended for professional use, which delivers results in less than 10 minutes at the point-of-care.
The Company is currently completing validations in accordance with the “Policy for Diagnostic Test for Coronavirus Disease – 2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturer, and Food and Drug Administration Staff issued on March 16, 2020 for Serological Diagnostics.” ThermoGenesis will notify the FDA upon completion of validation prior to product launch.
Chris Xu, Ph.D, Chief Executive Officer of ThermoGenesis, commented, “The Company has been in discussions with healthcare distributors, healthcare institutions, medical practitioners and government agencies, and is working quickly to bring the COVID-19 Test Kits to the U.S. professional medical community. This Kit will not only allow pre-screening for COVID-19 infections, but will also allow identification of individuals who have encountered the virus and have developed protective immunity. This will be essential in expediting the safety required to get the nation back to work in the future.”
About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, Inc., formerly known as Cesca Therapeutics Inc., develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect the current expectations of ThermoGenesis concerning future events and results. Forward-looking statements based on ThermoGenesis’ current assumptions, expectations and beliefs are generally identifiable by use of words “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” or similar expressions and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. Such forward-looking statements, including statements regarding the intended use of net proceeds from the registered direct offering as well as those factors concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, market and other conditions, as well as those risk factors discussed in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) as well as other documents that may be filed by ThermoGenesis from time to time with the SEC, which are available at www.sec.gov. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
Paula Schwartz, Rx Communications