Replacing 50-year-old chemical diagnostics, such as PCR and antigen tests, with printed nanosensors is expected to significantly disrupt the $50-billion diagnostics industry, not only for COVID-19 but for a wide range of diseases, said IdentifySensors Biologics CEO, Gregory Hummer, MD.
"We are excited to announce that we have proven this breakthrough concept and have moved into the large-scale manufacturing stage," Dr. Hummer said. "Purdue University has been a great partner helping with the development. We will continue working with the university's scientists on a series of sensors for additional pathogens on this platform."
Check4 by IdentifySensors Biologics has moved its newly proven nanosensor technology to the commercialization stage. The company intends to produce a pathogen-testing platform that rapidly and accurately detects a wide range of infections, including COVID-19, Influenza, Hepatitis C, Lyme and HIV. The reusable reader sends results to a user's smartphone.
IdentifySensors Biologics has applied the new technology to a commercial device called Check4™, an over-the-counter reusable reader that integrates with a consumer's smartphone. Single-use test cartridges, which will be sold separately, slide into the reusable reader and send test results from a saliva sample wirelessly to a phone in minutes.
Unlike a chemical PCR test, the rapid Check4™ device requires no amplification, reagents or laboratory work. The test's accuracy often surpasses PCR tests, while each test cartridge is expected to cost less than $25. Purdue University soon will begin developing new test cartridges for Influenza, Lyme, HIV and MRSA.
IdentifySensors Biologics has begun raising capital to fund its large-scale production of the platform. For details, visit the company's investment page. The company plans to seek FDA approval this summer, while taking orders from organizations and governments that do not require FDA approval.
"This new platform technology takes pathogen testing down a completely different path than all the other diagnostic tests out there," said Richard Kuhn, director of Purdue University's Institute of Inflammation, Immunology and Infectious Disease.
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