Facilitating the 'Vaccine Era' of COVID-19 Response: ThermoGenesis to Receive U.S. Patent for Breakthrough Serological Test Reader Technology

RANCHO CORDOVA, Calif., Oct. 20, 2020 /PRNewswire/ -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO) today announced that it has received notification from the United States Patent and Trademark Office (USPTO) of its intent to issue U.S. Patent No. 10,823,746 on November 3, for the Company's new breakthrough lateral flow immunoassay test reader technology, the ThermoGenesis Reader. The application leading to this patent, titled, "Lateral Flow Immunoassay Test Reader and Method of Use," was accepted by USPTO under its recently announced COVID-19 Prioritized Examination Program.

The ThermoGenesis Reader's technology is specifically designed to facilitate the efficient utilization of America's COVID-19 vaccine stocks as we enter 'The Vaccine Era' of COVID-19 response. For more information please visit  https://thermogenesis.com/covid-19-test-kit/

As the United States Centers For Disease Control and Prevention (CDC) explains in its recent guidance to public health programs on how to plan and operationalize their vaccination responses:[1] "A key point to consider is that vaccine supply will be limited at the beginning of [America's national immunization] program." The CDC illustrated this with a hypothetical scenario in which only 15 million doses might be available three months after the first vaccine is approved.

Anticipating the potential need for a 'seronegatives first' triage strategy while vaccine supplies are limited, ThermoGenesis has designed its new reader technology to facilitate the widespread use of inexpensive, mass-produced, FDA-authorized SARS-CoV-2 lateral flow immunoassay (LFIA) tests to distinguish seropositive members of populations of concern (individuals who already have SARS-CoV-2 antibodies), who might therefore be a lower priority for the earliest immunization. Seronegative members of these populations of concern (individuals altogether lacking SARS-CoV-2 antibodies) could thereby be prioritized.

"We have consulted with leading public health experts from industry, government and academia who have advised us that U.S. Food and Drug Administration (FDA) authorization of the first COVID-19 vaccines won't be the beginning of the end of this pandemic, but rather the end of the beginning," said Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis. "The challenge we are addressing comes in anticipation of an initially limited vaccine supply that will be administered on a prioritized basis to only a small fraction of the population. Our innovative technology, the ThermoGenesis Reader, is a robust, inexpensive, widely deployable, easy-to-use solution that will enable the tracking of vaccine recipients' antibody response over time, both to presumptively confirm immune status and to determine when booster immunizations may be required by individuals whose initial vaccine responses are waning. Lateral flow immunoassays are the fastest, least expensive, and most readily mass-produced serological tests for the kind of high-volume testing this will require, and the portable precision of the ThermoGenesis Reader will unleash LFIA's power to help carry us through to the ultimate eradication of this virus through an optimally efficient immunization strategy."

ThermoGenesis plans to complete current beta testing of its new reader and enter into production in December, in time for the anticipated approval of one or more vaccines around the end of this year.

Key features of the ThermoGenesis reader's design include:

• High precision and sensitivity of laser-scanning densitometry, for quantitative photometric detection and photometric quantification of positive test results.
• Hand-held, and rechargeable battery-power, for use anywhere authorized LFIA tests are administered, indoors or out.
• Unique and fully automated self-calibration, ensuring each Reader, in any operator's hands, will produce the same photometric results for a given test cartridge.
• Novel technology that makes laser scanning without powered moving parts possible, reliable, and inexpensive.
• Connected data technology for upload of test scan data to a cloud-connected database. Scan data is securely digitally signed on the reader to ensure the integrity of data both in motion and at rest.
• Instant (less than 3 seconds) quantitative photometric readouts.
• The industry's lowest-priced LFIA reader without sacrificing high performance, thanks to its uniquely efficient patent-protected technology.

The ThermoGenesis Reader will accept only LFIA cartridges that have been validated for use with the reader and certified by ThermoGenesis. The FDA-authorized COVID-19 LFIA cartridge manufactured by BioHit Healthcare (EUA200192/S002) is the first cartridge to receive this certification. Work is currently under way with additional manufacturers who are seeking ThermoGenesis certification for their own products.

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.

Company Contact:
Wendy Samford
916-858-5191
[email protected]

Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
[email protected]

[1] COVID-19 Vaccination Program: Interim Playbook for Jurisdiction Operations (2020). Centers for Disease Control.

https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf

SOURCE ThermoGenesis Holdings, Inc.

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