ThermoGenesis Receives Acknowledgement Letter from FDA Allowing Its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit for Distribution
RANCHO CORDOVA, Calif., April 16, 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 today that on Wednesday April 15th, following submission of notification to the U.S. Food and Drug Administration (FDA), the Company has received the necessary acknowledgement letter which provided confirmation that the ThermoGenesis' SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated in accordance with Section IV.D. of the "Policy for Diagnostic Tests for Coronavirus Disease - 2019 during the Public Health Emergency," issued by FDA on March 16, 2020. The required registrations and listings with FDA have been completed, which now allow the diagnostic kit to be distributed.
An informational presentation on the COVID-19 Kit is available on the Company's website. The presentation is for educational purposes and will allow users to better understand how the antibody test works and how to evaluate the results. Please visit the link below:
As previously announced, the COVID-19 Kit will be jointly marketed by ThermoGenesis and ImmuneCyte Life Sciences, Inc. Inquiries from health professionals and the media about the Kit should be directed via email to [email protected].
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.
About ImmuneCyte Life Sciences, Inc.
ImmuneCyte develops and commercializes immunological products and services. The Company provides clients the opportunity to bank their own immune cells when the cells are "healthy and unaffected" as a future resource for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes a proprietary CAR-TXpress™ platform, a GMP compliant close-system capable of automated separating and cryopreserving different components from blood. For more information about ImmuneCyte Life Sciences Inc., please visit: www.immunecyte.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
[email protected]
Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
[email protected]
SOURCE ThermoGenesis Holdings, Inc.
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