ThermoGenesis Holdings Enters into Supply Agreement with New EUA Approved COVID-19 Antibody Test Manufacturer; Marketing to Begin on August 17, 2020
ThermoGenesis Holdings, Inc. (Nasdaq: THMO) announced a supply agreement with BioHit Healthcare to market a SARS-CoV-2 IgM/IgG Antibody Test Kit, which has received Emergency Use Authorization (EUA) from the FDA. Marketing of the test kit is set to begin on August 17, 2020. The company has also withdrawn its own EUA submission for a previously announced antibody detection kit. ThermoGenesis is working on a companion reader to enhance serological testing accuracy and tracking, aiming to contribute to pandemic monitoring efforts.
- Supply agreement with BioHit Healthcare allows access to a new antibody test kit.
- The new test kit has received FDA Emergency Use Authorization, enhancing market credibility.
- Development of a companion reader aims to improve testing accuracy and usability.
- Withdrawal of the EUA submission for the original SARS-CoV-2 antibody detection kit may raise concerns about its viability.
- Potential delays in relaunching the updated product could impact market presence.
RANCHO CORDOVA, Calif., Aug. 13, 2020 /PRNewswire/ -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced that on August 12, the Company entered into a supply agreement with BioHit Healthcare (Hefei) Co., Ltd. to market, under the ThermoGenesis brand, its SARS-CoV-2 IgM/IgG Antibody Test Kit, which has already received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Company simultaneously withdrew its own EUA submission for the previously announced SARS-CoV-2 (COVID-19) Antibody Fast Detection Kit (Colloidal Gold). The new ThermoGenesis branded SARS-CoV-2 IgM/IgG Antibody Test Kit is expected to initiate marketing on August 17, 2020.
As previously announced, the Company has recently filed patent applications for a companion reader which quantifies and improves the speed and accuracy of serological assays, and also allows for disease incidence tracking within a population. The Company intends to realign its internal product line to file an updated EUA application, at a later date, for the cartridge reader and companion serological assays to encompass the "next generation" product which the Company believes could play an important role for pandemic monitoring.
Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis, commented, "ThermoGenesis aspires to enhance America's response to the COVID-19 crisis with the best-performing and most reliable COVID-19 fast serology test. Our research and development program has continued to advance our goal of developing a robust, inexpensive, cloud-connected, quantitative digital reader for our rapid tests. We believe this combination will significantly advance the role of rapid serological testing and public health monitoring during the COVID-19 crisis, serving the needs of government agencies, schools, large and small employers, and others, for mass screening efforts. Given the scientific community's growing understanding of the dynamics of both seroconversion and seroreversion in COVID-19, we believe that our best opportunity to contribute meaningfully to America's pandemic response is to focus on addressing critical unmet needs, especially towards reopening of schools and the economy, at large."
Information related to ThermoGenesis' new SARS-CoV-2 IgM/IgG Antibody Test Kit is available on the Company website. Please visit the link below:
Inquiries from health professionals and the media about the Kit should be directed via email to ir@thermogenesis.com.
About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, 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.
Forward-Looking Statements
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 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.
Company Contact:
Wendy Samford
916-858-5191
ir@thermogenesis.com
Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com
View original content:SOURCE ThermoGenesis Holdings, Inc.
FAQ
What is the significance of ThermoGenesis' supply agreement with BioHit Healthcare?
When will the new antibody test kit by ThermoGenesis be available?
What impact does the withdrawal of EUA for the original antibody test kit have on ThermoGenesis?
How does ThermoGenesis plan to enhance its serological testing?
