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
By Benjamin Boettner
(BOSTON) — 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.
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.
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.
[This new swab] 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.
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 non-exclusive, royalty-free 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.