One of the challenges for diagnosing Covid-19 is that its symptoms mirror those of other respiratory infections. Tests can determine which infection a patient has, but Edward Gillen, CEO of diagnostics startup GRIP Molecular, notes that a test at a clinic takes time to schedule, time spent in a waiting room, and more time waiting for results.
If a Covid-19 test turns returns a negative result, another test can be done to see if the problem is influenza A or B. There’s also a separate test for respiratory syncytial virus, yet another infection that presents in a similar way. However, it’s rare for a person to get all three tests, Gillen said. GRIP is developing a diagnostic intended to detect those diseases and others in a single test. Moreover, the technology will enable people to run those tests at home, producing results in minutes.
The diagnostic from the St. Paul, Minnesota-based startup is still in development, and it won’t be ready for consumers in the near future. But Gillen notes that the company got its start before Covid-19, and the technology will continue to fill a need even when the pandemic abates. GRIP, which was named the winner in the diagnostics track at the Pitch Perfect competition at MedCity News’ INVEST Conference in April, is continuing to make progress and it is now turning to potential investors as it seeks its first private investment.
The way diagnostics have traditionally worked is by taking a specimen and testing it against a reagent, a substance that produces a chemical reaction that identifies a pathogen. In a lab, it’s a process that can require multiple instruments and multiple steps, some of them done at specific temperatures. GRIP shrinks the diagnostic process down to a handheld device, a biosensor housed inside a cartridge a bit bigger than a poker chip.
“It’s a combination of biology, science, digital technology, digital health or telehealth, and diagnostics,” Gillen said. “We’re at the intersection of a lot of cutting edge technologies that we think will transform diagnostics.”
The foundation of GRIP’s technology is an integrated circuit. Such circuits are found in many electronic devices, including some medical devices. But integrated circuits have not worked well in medical applications because the materials they use interfere with biological processes, Gillen said. GRIP’s integrated circuit uses graphene, a carbon material that is both conductive and biocompatible.
To run a test, a small specimen, such as saliva or a sample from a nasal swab, is placed in the biosensor. The graphene has “capture molecules” that are 3D printed onto the material. These molecules bind to a biomarker for a target pathogen, such SARs-CoV-2 or influenza. Running the diagnostic requires electricity, which is provided by inductive charging: The near-field communication capability of a consumer’s mobile device powers the cartridge. The electrical field that’s created pulls in the biomarkers, facilitating their binding to the capture molecules. When that binding happens, the integrated circuit detects it and that information to the mobile device. An app on the device tells the user which pathogens were detected.
Testing for multiple pathogens using technologies currently available in a central lab can run between $180 to $250 and take a week to produce results, Gillen said. GRIP is developing its diagnostic to test up to 32 biomarkers simultaneously, producing results in about five minutes. Gillen expects a cartridge could sell in a pharmacy for $40. The app will be made available for download to consumers’ phones.
The market for at-home molecular Covid-19 diagnostics has competition. Last year, Emeryville, California-based Lucira Health was the first company awarded FDA emergency use authorization for an at-home Covid diagnostic. That test takes about 30 minutes to produce a result and it only diagnoses Covid. Mammoth Biosciences is developing a CRISPR-based test for home use. When the South San Francisco-based company disclosed $195 million in financing last month, CEO Trevor Martin told MedCity News that Mammoth’s diagnostic panel would test for several respiratory pathogens, including SARS-CoV-2, and the goal is a room-temperature test that yields a result in less than 30 minutes.
The GRIP technology is a platform and Gillen envisions developing it for many uses, such as detecting sepsis, sexually transmitted diseases, and urinary tract infections. The technology could even be used for head injuries, identifying the biomarkers associated with a concussion. As long as a biomarker can be found in a liquid, the GRIP diagnostic can detect it, Gillen said. But the technology’s initial application will be respiratory infections.
GRIP was founded in 2019 by Bruce Batten, a diagnostics industry veteran who is the startup’s president and chief scientific officer. The company’s science was licensed from the University of Minnesota. Gillen, whose experience includes 23 years at Becton Dickinson, joined as CEO last year. GRIP has a prototype of its technology now. Gillen said further product development could take another two years, leading up to a filing for marketing clearance under the FDA’s 510(k) pathway.
In the near term, GRIP is looking to raise money. Gillen said he has spoken with venture capital firms about a Series A round of financing that could total $12 million. If all goes well with product development and the diagnostic receives FDA clearance, Gillen projects a product launch in mid-2023.
Photo: Matthew Lloyd/Bloomberg, via Getty Images
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