NEW YORK ─ Harvard University's Wyss Institute said a recent non-exclusive licensing agreement it inked with Sydney-based iQ Group Global marks a significant step toward developing and seeking adoption for an electrochemical detection technology called eRapid.
eRapid uses a proprietary nanocoating to reduce biofouling and non-specific binding, increasing test accuracy. The platform, under development for the past two years, could be used to do multiplexed electrochemical detection for a variety of conditions at the point of care by recognizing antigens or antibodies associated with infections and disease, eRapid's lead developer and Wyss Senior Staff Scientist Pawan Jolly said in an interview.
For its part, "iQ Group's highly sensitive biosensing platform incorporates organic thin-film transistor technology and also targets applications at the point of care, making it a good fit with our nanocoating and electrochemical detection method for the development of a serology test for SARS-CoV-2," Jolly said.
The licensing agreement enables the integration of the Wyss Institute's detection technology with a platform that "delivers highly sensitive and specific bioelectronic sensors manufactured using roll-to-roll printing facilities," said Paul Dastoor, the inventor of the iQ Group thin-film biosensor at the Centre for Organic Electronics at the University of Newcastle in New South Wales, Australia.
iQ Group purchased the right to commercialize the organic thin-film biosensor platform from the University of Newcastle in 2016. The biosensor leverages electronic inks and roll-to-roll manufacturing, meaning it could be fabricated at a "low cost and massive scale," Dastoor said.
Further, iQ Group Global, a consortium of companies working to fund and develop bioscience discoveries, believes its organic transistor technology has the potential to be applied in a broad range of test applications. The organization has been using it to develop a saliva-based glucose biosensor to detect diabetes and is doing research and development as part of a program with the University of Newcastle to develop the platform for the detection of tumor, hormone, and communicable disease markers.
Jolly noted that eRapid is also suitable for development to provide testing in a broad range of medical conditions, and the Wyss Institute researchers have reported high performance in internal studies, observing electrical signals with picogram-per-mL sensitivity.
Separate from iQ Group, Jolly and his colleagues have been developing eRapid as the basis of a SARS-CoV-2 serology test for use in physicians' offices, pharmacies, or at home. In the test, SARS-CoV-2-specific antibodies attached to the platform's antifouling nanocomposite coating capture viral proteins or antibodies against the virus. Upon chemically detecting virus-specific molecules, eRapid generates an electrical signal whose strength correlates with the levels of target molecules present in the sample.
Overall, the platform enables multiplexed detection of a broad range of biomarkers, including proteins and antibodies in small quantities of complex biological fluids, such as blood and saliva, Jolly said, and Wyss Institute researchers have been exploring its development for the multiplexed detection of other disease markers, including cardiac and sepsis markers.
In a study published in Nature Nanotechnology in 2019, they described the development of a nanocoating to overcome biofouling, a process that has hindered the adoption of electrochemical sensors in development for diagnostic applications.
"The nanocomposite coating used to reduce non-specific binding is of interest to anyone working on immunoassays because of how it enables higher sensitivity," said Nicholas Collier, chief technology officer at Cambridge, UK-based Sagentia, an IVD product development company. Of particular interest to point-of-care test developers is the demonstration of multiplexing by "putting multiple electrochemical electrodes together into the same sample flow cell," said Collier, who is not affiliated with the Wyss Institute or iQ Group.
If the developers can achieve commercialization, future use of the eRapid platform to determine whether an infection is viral or bacterial could be of particular interest for diagnosing patients presenting with symptoms of sepsis, Collier said, and added that the multiplexing of cardiac biomarkers could also prove useful to clinicians looking for quick results in the emergency room.
Further, because eRapid uses electrochemical biosensing, it lends itself to roll-to-roll transistor fabrication, which is being employed by iQ Group. "With electrochemical biosensing, you can take advantage of printed circuit board technology including depositing tracks and coatings, and it lends itself to high-density fabrication," Collier said. Additionally, by using electrical signals, eRapid further avoids the use of precise optical components that need to be aligned with the test cartridge for detection and can drive up cost and complexity, he added.
As can happen with almost any multiplex panel involving the detection of different analytes, balancing sensitivities to detect various markers being targeted at once can be a challenge and also a restraint on the type and number of specific makers you can include in a panel, Collier noted. Additionally, with the use of antibodies during test development, there are always concerns about cross-reactivity, "but it appears that the Wyss Institute researchers have gotten around that," he said.
Robyn Schlicher, director of commercialization at the iQ Group, said that the consortium plans to commercialize the SARS-CoV-2 test that includes eRapid technology for diagnostic and pre-vaccination screening, and as an accompanying diagnostic to test patients for antibodies when a vaccine is available.
Following further development, iQ Group anticipates taking the SARS-CoV-2 test through clinical trials and seeking regulatory approvals, Schlicher said, and it plans to eventually launch the SARS-CoV-2 diagnostic test in the US, Europe, Asia-Pacific, and the rest of the world.
Because the test is still in development and has not undergone validation, the timing for its release as a potential clinical test is unclear. However, it could take about two years to develop most tests that include eRapid technology based on its current stage of development, Shawn Marcell, president and CEO of Wyss Institute spinout Torus Biosystems, said in an interview.
Marcell is the cofounder of Boston-based ReadCoor, a spinout of the Wyss Institute, acquired for $350 million by Pleasanton, California-based 10x Genomics in October. He worked with Jolly on the development of eRapid prior to becoming CEO of Torus toward the end of last year.
Earlier this year, the Wyss Institute decided the best commercial path for eRapid was to license it to a larger company that could develop applications and bring it to market, Marcell said.
"It's a promising platform and should be very successful in the right hands," he added.