Today, the Wyss Institute for Biologically Inspired Engineering at Harvard University and Spear Bio, Inc. announced that the Institute’s ultrasensitive DNA nanotechnology-driven SPEAR protein detection technology has been licensed to the newly formed Boston-based startup. Spear Bio has signed an exclusive worldwide licensing agreement with the Harvard Office of Technology Development (OTD), granting SPEAR Bio the rights to commercialize the SPEAR protein discovery technology. Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-only applications.

Developed in the group of Wyss Core Faculty member Peng Yin, Ph.D., SPEAR technology enables ultrasensitive detection of proteins in small patient samples, such as a drop of blood from a finger stick, dried smear samples of blood and other biofluids received. with the help of micro-sampling techniques, using existing laboratory equipment, including the now ubiquitous qPCR machines. Spear Bio plans to use SPEAR technology to build a broader protein detection platform and will first focus on commercializing an ultra-sensitive assay that can accurately measure levels of neutralizing antibodies (NAbs) against SARS-CoV -2.

The generation and levels of NAbs are a key metric for understanding protective immunity and vaccine efficacy, and SARS-CoV-2 detection assays are tools used by the Centers for Disease Control, as well as vaccine and drug developers, to determine sensitivity. of individuals to infectious pathogens such as COVID-19. The ability to sensitively and accurately quantify them in small and easy-to-obtain patient samples can significantly increase the depth and scope of such studies and enable different types of research. future and diagnostic analyses.

The invention of SPEAR was made possible by the major advances in DNA nanotechnology that we have made at Wyss over the years, including the prescribed and signal-dependent synthesis of readable DNA sequences. The discovery platform that Feng Xuan built and then significantly compromised with other members in the lab now has significant potential for developing immunoassay products for clinical research and in vitro diagnosis in the short term.”

Peng Yin, Ph.D., Director of the Wyss Institute’s Molecular Robotics Initiative and Professor of Systems Biology, Harvard Medical School (HMS)

Yin, who co-founded Spear Bio, previously co-founded other startups, including Ultivue Inc., NuProbe Global, Torus Biosystems Inc., 3EO Health and Digital Biology, Inc., which leverage technologies developed in his Institute lab Wyss.

Feng Xuan, Ph.D., was a postdoctoral fellow in Yin’s team and also became a co-founder of SPEAR Bio and is now the company’s CTO. During the development of the technology, he worked with co-inventors Cherry (Tsz Wing) Fan, Ph.D., and Yu Wang, Ph.D., and other members of the group. Wang is now the Acting Head of Application Development at SPEAR Bio.

In SPEAR, which stands for “Sequential Proximity Expansion Amplification Reaction,” small amounts of proteins, including NAbs, can be detected via target-binding probes that bind to different but proximal sites on a protein’s structure . This proximal double-labeling event allows the two probes to “shake hands”, with their interaction triggering a specifically designed sequential elongation reaction, and the synthesis of a unique DNA sequence which can then be amplified and measured using standard qPCR instruments. Importantly, in the absence of detection targets, interaction between free-floating probes does not allow synthesis of the complete DNA sequence, significantly reducing background compared to conventional proximity-based assays. SPEAR is superior to other protein detection assays in its combination of extreme sensitivity, wash-free workflow, and functionality over a large range of target protein levels (dynamic range) with the ability to be fully effective at volumes of samples up to 1 uL. The technology was compromised with the help of the Wyss translation engine, in which it received the status of first a Validation Project and then an Institute Project, designated to support the development of high-value technologies with high market potential. success.

“The extreme sensitivity in very small sample volumes offered by SPEAR and the fact that it can be read out using common quantitative PCR equipment offer unique potential for microsample-based design. in vitro diagnostics that can transform academic and clinical research in multiple disease areas,” Xuan said.

Spear Bio is currently applying the assay to quantify SARS-CoV-2 NAb in dried blood samples, and thereby aims to facilitate the COVID-19 disease and vaccine research. Beyond this first application, the company plans to use the assay to develop other research and diagnostic applications that require ultrasensitive and quantitative detection of protein biomarkers in small samples. “SPEAR’s unique capabilities give us a clear value proposition for market entry.” said Oliver Tassinari, Sr. Director of Business Development at SPEAR Bio. “We are now laser-focused on translating the outstanding technical performance of the assay technology into a satisfying customer experience to solve problems related to research and diagnostics.”

Harvard initially granted SPEAR Bio access to this technology on a non-exclusive basis, for a limited term, in accordance with the University’s commitment to the COVID-19 Technology Access Framework. The framework enables broad access to emerging technologies to drive rapid innovation in pursuit of solutions to combat the pandemic.

“Our ability to detect ever-smaller amounts of biomolecules across all molecular species with increasing speed and specificity, and in diverse environments including dried blood samples, opens entirely new approaches to medical diagnostics that can used in both home and hospital settings.Wyss’ SPEAR protein detection technology, developed by Peng Yin’s group, is at the forefront of this field and should help move the needle in terms of rapid clinical assessment of patient protection after vaccination or infection during COVID-19 in the near term.” said Wyss Founding Director Donald Ingber, MD, Ph.D., who is also Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and Hansj√∂rg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.


Wyss Institute for Biologically Inspired Engineering at Harvard

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