IdentifySensors Biologics, the nanotechnology company in Shaker Heights, Ohio, has begun to raise capital to pay for large-scale production of its over-the-counter test that detects the novel coronavirus.
In partnership with Purdue University, IdentifySensors developed a technology platform that uses electronic nanosensors to detect the genetic material of numerous pathogens, including the coronavirus that causes Covid-19.
The printed nanosensor platform could replace older chemical technologies, such as PCR and antigen tests, and disrupt the $50-billion diagnostics industry, said Dr. Gregory Hummer, CEO of IdentifySensors Biologics, in a statement.
"We will continue working with the university's scientists on a series of sensors for additional pathogens on this platform," Hummer said.
IdentifySensors Biologics has applied the new technology to a commercial device called Check4, an over-the-counter, reusable reader, expected to cost about $130, that works with a consumer's smartphone.
Single-use test cartridges, which will be sold separately, slide into the reusable reader and wirelessly send test results from a saliva sample to a phone in minutes, the company said.
Unlike a chemical PCR test, the rapid Check4 device requires no amplification, reagents or laboratory work and often is more accurate, the company said.
Each IdentifySensors test cartridge is expected to cost less than $25. Purdue University soon will begin developing test cartridges for influenza, Lyme disease, HIV and MRSA, it said.
IdentifySensors Biologics plans to seek Food and Drug Administration 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, in a statement.
