ThermoGenesis’ Breakthrough Lateral Flow Immunoassay Test Reader to Help Track Antibody Response of COVID-19 Vaccine Recipients

A new breakthrough lateral flow immunoassay test reader technology aims 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 be a lower priority for the earliest immunization.

The ThermoGenesis Reader from ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA) has been specifically designed to facilitate the efficient utilization of COVID-19 vaccine stocks in the US as we enter 'The Vaccine Era' of COVID-19 response. According to the Centers for Disease Control and Prevention (CDC), only 15 million doses of COVID-19 vaccine might be available three months after the first vaccine is approved. ThermoGenesis has designed its new reader technology in anticipation of the potential need for a 'seronegatives first' triage strategy while vaccine supplies are limited. Seronegative members of the populations of concern (individuals altogether lacking SARS-CoV-2 antibodies) could be prioritized. ThermoGenesis Reader will also 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.

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. The company has also received notification from the US Patent and Trademark Office (USPTO) of its intent to issue a patent for the company's new breakthrough lateral flow immunoassay test reader technology.

"We have consulted with leading public health experts from industry, government and academia who have advised us that US 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."

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