NEW YORK ─ Grip Molecular Technologies is developing a single-use, multiplex diagnostic testing platform that uses electronic biosensors to simultaneously detect DNA, RNA, and protein biomarkers for a range of infectious diseases, with a near-term focus on launching a panel for upper respiratory infections including SARS-CoV-2.
The platform consists of biosensors housed within a cartridge the size of a poker chip, with each targeting a single disease biomarker, Grip Molecular CEO Edward Gillen said in an interview.
On the back of encouraging internal validation studies, according to Gillen, the company is preparing to enter retrospective and prospective clinical studies to evaluate the platform. It expects to file an application around the middle of next year for US Food and Drug Administration clearance of a panel that would detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus.
Though the panel would be Grip Molecular's first test in the market, the company longer term anticipates adding biomarkers for additional respiratory infections, streptococcus, and sepsis, among other ailments, Gillen said.
"What we're developing is a very easy-to-use, highly accurate system that will detect a number of diseases simultaneously within minutes in the home or elsewhere," he said.
Gillen added that for ease of use, the company is developing a system that operates without a reader, electric power, batteries, or a charger. Instead, the system uses a single cartridge that connects to a cell phone and is discarded after use. Because the cartridge requires very low electrical power, it uses electromagnetic radiation from a cell phone for power.
Its multiplexing capabilities are enabled by combining up to 32 biosensors, measuring 10 to 20 microns apiece, within a chip-sized fluidic cartridge. One of its essential technologies, Gillen noted, is the use of graphene, a biosensor material that can be manufactured cheaply by using inkjet printing.
During testing, nucleic acids, proteins, or aptamers developed to detect disease markers are adhered to the graphene biosensors as capture molecules, and the graphene material, made of single atom sheets of carbon, generates an electrical signal upon the binding of the capture molecules to their target biomarkers.
The conductivity of graphene and its sensitivity to binding events are the foundation of the platform's performance, which matches that of laboratory tests in internal validation studies, Gillen said, adding, "The biosensors inside the cartridge immediately interrogate the sample, and when the device is brought into proximity with a standard cell phone, the results are transmitted wirelessly."
If the device can be commercialized, a test would be taken by collecting a nasal or saliva sample in a small test tube that consists of a transport buffer and by injecting the contents of the test tube into the cartridge using a small syringe.
The technology would enable the downloading of test results to a cell phone where they can be securely stored for interpretation by the patient and physicians. An app is downloaded by placing the cell phone camera over a barcode on the test packaging, and the cartridge uses near-field communication technology to communicate results to the phone.
Though the St. Paul, Minnesota-based startup was founded in 2019, many of the technologies that underpin its point-of-care platform have been in development for several years, Grip Founder, President, and CSO Bruce Batten said in an interview.
"At the time, we were considering infectious diseases applications, but we certainly hadn't been thinking about a pandemic," he said.
Batten noted that Grip's respiratory panel will detect proteins that are part of the virus outer surface. To test for SARS-CoV-2, for example, the panel detects the spike protein.
All pathogen biomarkers detected by its panels will be either proteins or nucleic acids that have been well characterized in the literature, he noted, adding that in collaboration with Boston College, Grip is also designing aptamers as capture probes for target biomarkers.
Some of the aptamers have been published in the literature and the firm is modifying them to enable attachment to graphene, Batten said.
Since 2019, the firm has raised $4.1 million in financing, mainly from angel investors, and it is preparing a Series A round from which it expects to close around $12 million from venture capital investors this summer, Batten said.
He noted that in recognition of the potential of its testing platform, Grip was recently accepted into Blue Knight, a joint initiative between Johnson and Johnson Innovation – JLabs, which is a network of life science business incubators, and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA).
As part of the Blue Knight initiative, Grip is using office space at JPod @ Boston, a coworking space for scientist entrepreneurs and life science startups in New England, located at the Cambridge Innovation Center in Massachusetts. The firm is receiving regulatory and commercialization advice as well as mentoring from J&J and BARDA executives.
Blue Night is "interested in technologies across the whole spectrum of pandemic preparedness — everything from early detection, diagnosis, and prevention to therapeutics, vaccines, and clinical trial acceleration," Rachel Rath, global lead of Blue Knight for Johnson & Johnson Innovation, said in an interview. Grip's "potential to do rapid detection through multiplexing for multiple respiratory pathogens, with some of its first targets being COVID-19, RSV, and influenza, is really important to us."
The Blue Knight initiative was launched in 2019 and has accepted 19 companies globally, including one other in vitro diagnostics firm, New York City-based mPod, which is developing an aptamer-based test for rapid detection of SARS-CoV-2 N-proteins for the diagnosis of COVID-19.
To be accepted into the initiative, experts at J&J and BARDA analyze company applications, looking for strategic alignment of the applicants' plans with those of their own organizations.
J&J and BARDA are particularly interested in the potential of Grip's technology to quickly port a newly identified infectious disease biomarker onto its platform and enable manufacturing at high volumes, Gillen said.
Though numerous biosensor-based tests are being developed for in vitro diagnostic applications, few have reached commercialization, and almost all commercial multiplex diagnostic testing platforms for infectious disease detection are based on nucleic acid amplification technologies.
One exception is a bulk acoustic wave SARS-CoV-2 antigen test developed by Greensboro, North Carolina-based Qorvo Biotech which last April received FDA Emergency Use Authorization for its biosensor platform and test.
A few groups are exploring the potential of graphene materials for biosensor-based diagnostic testing, including Catalan Institute of Nanoscience and Nanotechnology (ICN2) in Barcelona, University of Illinois at Chicago, and the University of Regensburg in Germany.
As it moves toward commercialization, Grip intends to use its current and future financing to support clinical validation. In internal studies involving nasal and saliva samples with inactivated virus, it is seeing sensitivity and specificity levels that are comparable to those of laboratory-based PCR tests and significantly exceed those of laboratory-based ELISA tests, Gillen said.
The company is preparing to kick off a retrospective study in June to test approximately 250 nasal swab samples from patients with SARS-CoV-2 or influenza that it has collected over the past year at an undisclosed healthcare center in Minnesota.
In the next six months, it also intends to launch a prospective study consisting of a few hundred nasal and saliva samples collected from patients with upper respiratory infections.
The firm believes the clinical studies will provide it with the performance and validation data it needs for a submission around the middle of next year to the FDA for clearance to market the upper respiratory panel. Grip also intends to apply for CE marking or In Vitro Diagnostic Regulation approval if needed, which would enable the marketing of its tests in the European Union and other geographies that accept the designation.
The company said it sees potential for sales directly to consumers and in numerous settings including hospitals, clinics, and retail pharmacies. It plans to hire account executives to manage distribution partners that it would select to target each sales channel, and it currently plans to sell its tests for $40 per panel, Gillen said. In the future, the company intends to pursue reimbursement for the panel with payors, he added.
"Though we are designing the platform for home testing, which is the most difficult use case, success there means we will be able to target all of the other use cases," Gillen said.