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
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:
"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
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
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
- Instant (less than 3 seconds) quantitative photometric
- The industry's lowest-priced LFIA reader without sacrificing
high performance, thanks to its uniquely efficient patent-protected
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.
Paula Schwartz, Rx
 COVID-19 Vaccination Program: Interim Playbook for
Jurisdiction Operations (2020). Centers for Disease Control.
SOURCE ThermoGenesis Holdings, Inc.