An advanced digital diagnostic platform with the capability to detect multiple pathogens in five minutes at the molecular gene level and priced significantly lower than current molecular tests is all set to disrupt the PCR market.

Check4 by IdentifySensors Biologics (Cleveland, OH, USA) is a next-generation digital diagnostic platform that has been developed to detect the genetic material of a wide range of pathogens for over-the-counter and point-of-care use. The Check4 testing platform comprises two components: a reusable Bluetooth reader roughly the size of a mobile phone, and disposable test cartridges that connect to the reader. Each test sample can simultaneously detect up to three different pathogens. Digital graphene sensors within the cartridges target conserved regions of the genome, thereby ensuring high sensitivity and specificity without the need for enzymatic amplification or reagents.

The sensors in the disposable cartridges can be customized to identify a broad range of pathogens that display similar symptoms. Multiplex tests are in development for respiratory pathogens (COVID, RSV, and influenza), gastrointestinal pathogens (Norovirus, Rotavirus, and Adenovirus), and sexually transmitted pathogens (HIV, Hepatitis, Chlamydia, Gonorrhea, and Herpes). Other tests under development include those for SEPSIS, MRSA, Lyme disease, and tropical pathogens such as Zika, Dengue, Yellow Fever, and West Nile virus. Previous research indicates that Check4 can potentially diagnose infections like COVID, RSV, and influenza even before patients exhibit symptoms. IdentifySensors has commenced testing this novel diagnostic device in anticipation of FDA submissions. Clinical studies for the Check4 diagnostic device are slated for this year as part of an extensive testing platform designed to be adapted for detecting a broad range of additional pathogens in the coming years.

"In preliminary studies we have seen encouraging results of this new technology," said Greg Hummer M.D., IdentifySensors co-founder and CEO. "We are excited to test these devices and move forward with additional targets that detect a wide range of infections." 

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