(BOSTON) — Today the Wyss Institute for Biologically Inspired Engineering at Harvard University and Cambridge-based StataDX Inc. announce that the Wyss Institute’s affinity-based, multiplexed, electrochemical sensing technology, eRapid, has been licensed to the startup.
The license, coordinated by Harvard’s Office of Technology Development (OTD), grants StataDX exclusive worldwide access to the eRapid technology in the fields of neurological, cardiovascular, and renal diseases. Sanjay Sharma Timilsina, Ph.D., and Nolan Durr, two key members of the Wyss Institute research team that extensively de-risked the technology, are joining two of StataDX’s external co-founders, Sidhant Jena, CEO and Michal Depa, CTO. The team will focus on developing diagnostic tests that can address critical unmet diagnostic needs in various near-patient settings, such as physician offices, pharmacies and eventually at home.
“We developed and de-risked this multiplexed electrochemical sensor technology that exhibits extremely high sensitivity and specificity, working together with multiple academic, clinical, and industrial collaborators,” said Wyss Institute Founding Director Donald Ingber, M.D., Ph.D. “Our team of highly talented research engineers who developed this technology have partnered with a passionate and seasoned entrepreneurial leadership team to form a new venture aiming to pioneer point-of-care diagnostics in areas that utterly lack them now, such as detection of traumatic brain injury in sports or on the battlefield. These ultimately could result in life-changing and life-saving outcomes for patients with a vast range of diseases.”
Ingber also leads the Wyss Institute’s Bioinspired Therapeutics and Diagnostics Platform, where eRapid was conceived and developed, and is the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and Hansjörg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.
The multidisciplinary eRapid team at the Wyss Institute led by Wyss Senior Staff Scientist Pawan Jolly, Ph.D., and Ingber developed the affinity-based electrochemical sensor technology as a low-cost multiplexed diagnostics platform that can simultaneously detect and quantify a broad range of biomarkers with high sensitivity and selectivity in a small volume of blood or other complex biological fluids. Ingber and Jolly are two of StataDX’s co-founders. Along with Jolly, Timilsina and Durr both were instrumental in advancing the eRapid platform through the Wyss Institute’s translation engine, and they now bring their expertise to StataDX’s engineering team and the commercialization process. Jolly presently is a consultant to StataDX.
“I am excited to team up with technical leads from the Wyss and my co-founder Michal Depa to take diagnostics to its final frontier—the patient's home. While there are many at-home tests for viral diseases such as COVID-19 available today, nothing yet exists for patients with complex chronic diseases such as multiple sclerosis, heart failure or chronic kidney disease that need periodic measurements of multiple biomarkers. The approach enabled by eRapid addresses underlying limitations of electrochemical biosensing in an elegant way, which may overcome the challenge faced by so many promising diagnostic technologies – the successful transfer to manufacturing at scale,” said Sidhant Jena, CEO and co-founder of StataDX. “Our decision to pursue neurology first stems from the significant healthcare burden of an aging population and the complete absence of a fingerprick blood test for the brain.”
The foundational discovery that started the development of eRapid was a novel antifouling nanocomposite coating that enables electrochemical electrodes to withstand the attack of biofouling molecules contained in various biofluids, including blood, and thereby maintains the electrodes’ sensing capabilities and minimizes any electrochemical background signal. Biofouling poses a pervasive challenge to the development of electrochemistry-based diagnostics, which could be used to solve important diagnostic problems.
By converting their original gold-based chemistry to a graphene-nanocomposite chemistry, the team further enhanced eRapid’s biomarker detection efficiency, and by developing a “dip coating method,” they reduced the time needed for coating sensor surfaces with the improved antifouling nanocomposite from 24 hours down to less than a minute. The advanced coating process dramatically reduced the fabrication costs for eRapid sensors and, in addition, made them storable for an extended period of time with minimal loss of electric signal. This increased their usefulness for future point-of-care diagnostic assays as testing can be done remotely and read on-site or sent to a central laboratory for analysis. Most recently, the team presented a comprehensive framework for developing highly effective diagnostic electrochemical sensors, using a broadened range of surface materials that prevent biofouling and enhance detection of a variety of biomarkers, including the neurofilament-light (NFL) protein, which is gaining interest as a potential diagnostic biomarker for multiple sclerosis.
Importantly, the coating can be used to embed probes for a broad range of biomarkers, including proteins, antibodies, metabolites, hormones, and RNA molecules that can be simultaneously detected in multiplexed electrode arrangements. “Upon chemically detecting a target biomarker, eRapid sensors produce electrical signals within minutes that correlate in strength with the levels of the bound biomarkers, much like a commercial glucometer used by diabetic patients does today, but with multiplexing capability,” said Timilsina. “This opens up a vast diagnostic space, given that many multifactorial diseases and disorders require simultaneous measurement of multiple biomarkers with high sensitivity and specificity in order to accurately diagnose, stratify, and monitor patients.”
“We showed in our extensive de-risking process at the Wyss Institute that the eRapid platform can address diverse live-threatening diseases and conditions with multiplexed biomarker measurements for which no accurate diagnosis existed before,” said Jolly. “This is one of the most promising forays of an electrochemical sensing technology into commercial stages with the prospect to fill important diagnostic gaps in critical areas with unmet needs,” Jolly also is the technology lead of the Wyss Diagnostic Accelerator (Wyss DxA) led by Wyss Core Faculty member David Walt, Ph.D. and Wyss Principal Scientist Rushdy Ahmad, Ph.D., an Institute initiative that enables the fast creation and validation of diagnostic technologies to solve pressing clinical problems through deep collaboration with clinicians and industry partners.
The early development stages of the eRapid technology were funded by a Defense Advanced Research Projects Agency (DARPA) grant awarded to Ingber that focused on building a human body on-a-chip, as well as the KeepSmilin4Abbie Foundation as part of Project Abbie. After the initial eRapid-enabling discoveries, the team advanced the technology through Wyss Institute-funded Validation and Institute Projects, reserved for technical and commercial de-risking of Institute technologies with high translational potential. In 2021, as part of Boston’s biotech ecosystem, the team obtained additional funding from MassVentures after being selected as the winner of its MALSI+ competition, which “is the Commonwealth of Massachusetts’ flagship event connecting scientific innovators, entrepreneurs, business leaders, and investors to celebrate the many ways Massachusetts leads the nation in bringing translational science to the market.”