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New Digital Platform Technology Aims to Disrupt 50-Year-Old PCR Testing for Similar-Symptom Pathogens

By LabMedica International staff writers
Posted on 14 Dec 2022
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Image: A breakthrough technology intends to reshape the future of diagnostic testing (Photo courtesy of IdentifySensors)
Image: A breakthrough technology intends to reshape the future of diagnostic testing (Photo courtesy of IdentifySensors)

Disease caused by bacteria, pathogens and pollutants presents a significant threat to human health, safety and security. Now, a disruptive new diagnostic testing platform intends to be completely different from any others currently on the market and reshape the future of diagnostic testing.

IdentifySensors Biologics (Shaker Heights, OH, USA), along with leading researchers at Purdue University (West Lafayette, IN, USA), has developed an innovative nanosensor technology, Check4. The technology platform uses electronic nanosensors to detect the genetic material of numerous pathogens, including the coronavirus that causes COVID-19. Check4 is intended to be as accurate as a PCR test in minutes without a prescription. A nanosensor cartridge interacts with saliva to produce a distinguishable electronic signal for positive or negative results with accuracy that rivals PCR tests. Using saliva and the user’s smartphone, results will be delivered within minutes.

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. The 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.

Check4 is easy to use and fast, accurate, and affordable. It is intended to avoid the limitations of current molecular tests such as enzymatic reactions, amplification, sample preservation or sample transportation, which can introduce artifacts and raise the risk of false positives. The technology avoids costly elements used by laboratory-based molecular tests such as enzymes and reagents that are in short supply. It also eliminates the need for laboratory technicians, diagnostic machines and personal protective equipment. The reusable reader is intended to cost about USD 130.

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