Harvard University licenses its nasal swab collection technology, developed at the Wyss Institute and Harvard Medical School, to Mass. startup Rhinostics

The combined technologies could reduce labor and time required for COVID-19 diagnostic testing 10-fold, and facilitate future diagnostic testing of other respiratory diseases.

BOSTON, May 4, 2021 /PRNewswire/ -- The Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard Medical School (HMS) and the Massachusetts-based startup Rhinostics announced today that the University's sample collection swab and high-throughput automation technologies have been licensed to Rhinostics. The company will further develop and commercialize automated and multiplexed solutions for processing nasal samples from people suspected to have COVID-19 or other respiratory infectious diseases. The license was coordinated by Harvard's Office of Technology Development (OTD) in accordance with the University's commitment to the COVID-19 Technology Access Framework.

The licensed technology was developed in a collaborative effort by researchers from Harvard's Wyss Institute and HMS, building on previous work by Wyss Lead Staff Engineer Richard Novak, Ph.D., with the Institute's Founding Director Donald Ingber, M.D., Ph.D., and work by Michael Springer, Ph.D., Associate Professor of Systems Biology at HMS.

"After developing a conceptually new type of nasal swab that can be manufactured faster, easier, and at lower costs than conventional absorbent swabs, we quickly realized that the costs and time of the COVID-19 diagnostic process leave ample room for improvement at all points of the process: it was imperative to optimize the entire patient-to-diagnosis pipeline. We designed a product for the collection of patient samples and associated personal data to integrate into a highly automated and rapid molecular analysis workflow and diagnostic data reporting," said Novak, who co-founded Rhinostics with Springer.

The Wyss Institute's original nasopharyngeal swabs were developed in a multi-institutional and multi-disciplinary group effort led by Novak and Ingber early in the pandemic as a simple and effective device with advantages over other designs. Conventional nasal swabs are manufactured in two parts from different materials that then need to be assembled, sterilized and packaged in a multi-step process, which requires considerable time and expense. The Wyss swabs are fully injection-molded from a single material, and as such, can be mass manufactured in a one-step process that is faster, less expensive, and routinely used by a broad range of experienced medical device manufacturers worldwide. In successful tests performed by academic collaborators and teaching hospitals, the unique nasal swab design was demonstrated to effectively collect SARS-CoV-2 genetic RNA material from the nasopharynx of patients and to be more comfortable than existing commercial products.

Springer's group at HMS had explored ways to multiplex (increase the throughput of) centralized rRT-PCR assays to diagnose COVID-19, while decreasing labor and costs. "We were trying to circumvent supply and performance limitations of swabs when I heard about the Wyss Institute's swab technology at a MASS CPR online event. I contacted Richard immediately, and 20 minutes later we were collaborating," said Springer. Novak had independently thought about possibilities to solve the problem of automatically removing the swab from the sample collection device. Together he and Springer developed a novel design. "This new swab performs comparably to other swabs in its ability to collect specimens, but due to its design that allows for low-volume elution without interfering with the swab material, it has superior performance in extraction-free methods. It enables us to improve the performance of a number of different assays, including rapid antigen tests, while offering the additional benefits of high-throughput accessioning and automation in centralized labs," said Springer.

With the overall aim to ultimately eliminate a slow, manual step in the laboratory analysis process, Novak and Springer had to make the nasal swab architecture compatible with automation instruments. They further modified the design by shortening the handle and attaching it to a threaded cap that screws onto a small vial for transport and integration into an automated fluid handling workflow. The capped swab can be manipulated by robotic systems to allow efficient automated cap-swap removal and transfer, as well as sample release. In addition, the collection tubes carry barcodes to allow clear sample-to-patient assignments. The automated parallel processing of samples in robotic devices could significantly speed up the diagnostic process for COVID-19 and allow other types of infectious disease diagnostics to become more routine and accessible. By using their approach, Novak and Springer estimate that the throughput of samples in clinical laboratories could be increased by a factor of 10 or more, which would tremendously help with the current diagnostic bottleneck.

Rhinostics Inc. is focused on bringing innovations to sample collection and the laboratory workflow to revolutionize dated procedures that have been in place for decades. "COVID-19 has shined a light on the need for novel materials and innovation to allow laboratories to bring in more samples, faster. The elegant solution developed by the Harvard teams brings needed change to this segment of the laboratory workflow. We are excited to work to bring these innovations to market," commented Cheri Walker, Chief Executive Officer of Rhinostics.

Harvard co-led the creation of the COVID-19 Technology Access Framework to incentivize the rapid utilization of available technologies that can facilitate the diagnosis, treatment, and prevention of COVID-19 infection in the fight against the pandemic. Accordingly, the license agreement crafted by Harvard OTD grants Rhinostics access to the technology for use in SARS-CoV-2 detection during the pandemic. For broad sample collection applications in the life sciences and diagnostics unrelated to the COVID-19 pandemic, including but not limited to flu and other viral infections, Rhinostics holds an exclusive license from Harvard.

"It is highly gratifying to see the nasal swab technology that we developed on-the-fly in response to the urgent need in the COVID-19 pandemic make this important step towards commercialization and its much broader use for diagnosis of respiratory diseases. Rhinostics is a great example of how the Wyss Institute can add value in the broader Harvard and Boston-Cambridge ecosystem by supporting collaborations in a seamless way that enables brilliant engineers and scientists like Richard Novak and Michael Springer to innovate and pursue their entrepreneurial dreams at a lightning pace," said Wyss Institute Founding Director Donald Ingber, M.D., Ph.D., who is also the Judah Folkman Professor of Vascular Biology at HMS, the Vascular Biology Program at Boston Children's Hospital, and Professor of Bioengineering at Harvard's John A. Paulson School of Engineering and Applied Sciences.

Wyss Institute for Biologically Inspired Engineering at Harvard University
Benjamin Boettner, benjamin.boettner@wyss.harvard.edu, +1 617-432-8232

The Wyss Institute for Biologically Inspired Engineering at Harvard University uses Nature's design principles to develop bioinspired materials and devices that will transform medicine and create a more sustainable world. Wyss researchers are developing innovative new engineering solutions for healthcare, energy, architecture, robotics, and manufacturing that are translated into commercial products and therapies through collaborations with clinical investigators, corporate alliances, and formation of new startups. The Wyss Institute creates transformative technological breakthroughs by engaging in high risk research, and crosses disciplinary and institutional barriers, working as an alliance that includes Harvard's Schools of Medicine, Engineering, Arts & Sciences and Design, and in partnership with Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana–Farber Cancer Institute, Massachusetts General Hospital, the University of Massachusetts Medical School, Spaulding Rehabilitation Hospital, Boston University, Tufts University, Charité – Universitätsmedizin Berlin, University of Zurich and Massachusetts Institute of Technology. For more information, please visit http://wyss.harvard.edu.

Harvard University's Office of Technology Development (OTD) promotes the public good by fostering innovation and translating new inventions made at Harvard University into useful products that are available and beneficial to society. Our integrated approach to technology development comprises sponsored research and corporate alliances, intellectual property management, and technology commercialization through venture creation and licensing. More than 70 startups have launched to commercialize Harvard technologies in the past 5 years, collectively raising more than $2.5 billion in financing. To further bridge the academic-industry development gap, Harvard OTD manages the Blavatnik Biomedical Accelerator and the Physical Sciences & Engineering Accelerator. For more information, please visit https://otd.harvard.edu.

Rhinostics Inc. commercializes simple and elegant solutions to bring efficiencies and cost savings to the laboratory workflow. The RHINOstic nasal swab provides features that increase sample throughput by more than 10-fold while removing labor and errors from the laboratory workflow. The swab is integrated onto a cap that can be automated for removal from the tube while all 96 samples are simultaneously accessioned through scanning a 2D barcode on the bottom of the tubes. The product provides an immediate impact to increasing COVID testing efficiencies while being applicable to broader respiratory viral, bacterial, and genetic testing using the polymerase chain reaction (PCR) and next generation sequencing (NGS). The RHINOstic product is registered as Class I exempt medical device with the FDA and is available for purchase. To learn more, visit https://www.rhinostics.com.

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SOURCE Wyss Institute for Biologically Inspired Engineering at Harvard University

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