IDENTIFYSENSORS BIOLOGICS REACHES BREAKTHROUGH SENSITIVITY LEVELS WITH NEW DIGITAL DIAGNOSTICS PLATFORM
Digital testing on saliva exceeds PCR sensitivity for immediate early detection and treatment.
CLEVELAND – IdentifySensors Biologics has completed preliminary clinical tests of positive COVID-19 samples using new graphene digital sensors, which demonstrate level-of-detection capabilities four times more sensitive than PCR tests.
The sensor devices were fabricated and tested in batches of 20 using heat-inactivated saliva samples as required by FDA Emergency Use Authorization standards. The saliva samples were collected from COVID-positive patients. Viral concentrations of the samples were quantified using RT-PCR. The samples were then diluted to the preliminary limit of detection of 200 copies per milliliter and retested using Check4®. Approximately 98 percent of the tests showed accurate rapid results from verified samples.
The research demonstrates that infections, such as COVID, RSV and influenza, can soon be diagnosed well before patients develop symptoms, said IdentifySensors Biologics Cofounder and CEO Gregory Hummer M.D.
“This is a significant breakthrough because now we can greatly reduce spreading viruses and treat infections before patients become sick,” Hummer said. “This rapid digital test connects to the cloud and allows patients to test at home. Doctors can read results remotely in real-time. This will have a substantial impact on individual health outcomes worldwide.”
The Check4® testing platform consists of two parts: a reusable Bluetooth reader about the size of a cell phone; and a disposable test cartridge that attaches to the reader. As many as three pathogens can be detected simultaneously from a single test sample. Digital graphene sensors inside the cartridges target conserved regions of the genome allowing for high sensitivity and specificity. No enzymatic amplification or reagents are used.
Sensors inside the disposable cartridges can be functionalized to detect a wide range of similar-symptom pathogens. Multiplex tests are being developed for respiratory (COVID, RSV and influenza), stomach (Norovirus, Rotavirus and Adenovirus) and sexually transmitted pathogens (HIV, Hepatitis, Chlamydia, Gonorrhea and Herpes). Other tests in development include SEPSIS, MRSA, Lyme and equatorial pathogens such as Zika, Dengue, Yellow Fever and West Nile. The company is preparing a COVID sensor submission for FDA review in 2023.
About IdentifySensors Biologics
IdentifySensors Biologics is a Cleveland-based nanotechnology company focused on developing real-time pathogen detection capabilities. The company’s technology has expanded into multiple industries and applications, such as pathogen diagnostics and testing for food contamination. For more information visit www.identifysensors.com