Today, the Wyss Institute for Biologically Inspired Engineering at Harvard University and Spear Bio, Inc. announced that the ultrasensitive SPEAR protein detection technology powered by the Institute’s DNA Nanotechnology has been licensed to the newly formed Boston startup. Spear Bio has signed an international, exclusive license agreement with the Harvard Office of Technology Development (OTD), granting SPEAR Bio the rights to commercialize the SPEAR protein detection technology. Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in low-volume samples with an initial focus on research-only applications.
Pioneered in the group of Wyss Core Faculty member Peng Yin, Ph.D., the SPEAR technology enables ultrasensitive detection of proteins in small patient samples, such as a drop of blood from a finger stick, dried blood spot samples, and other derived biofluids using of microsampling techniques while using existing laboratory equipment, including the now ubiquitous qPCR machines. Spear Bio plans to use the SPEAR technology to build a more widely applicable 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 .
NAb generation and levels are a key indicator for understanding protective immunity and vaccine efficacy, and SARS-CoV-2 NAb detection assays are tools used by the Centers for Disease Control, as well as vaccine and drug developers, to determining the susceptibility of individuals to infectious pathogens such as COVID-19. The ability to sensitively and accurately quantify in small, easy-to-obtain patient samples can greatly increase the depth and productivity of such studies and enable a variety of future research and diagnostic analyses.
The invention of SPEAR was made possible by key advances in DNA nanotechnology that we have made at Wyss over the years, including prescriptive and signal-dependent synthesis of readable DNA sequences. The detection platform that Feng Xuan built and then greatly de-risked with other members in the lab now has significant potential for developing immunoassay products for clinical research and IVF diagnostics in the near future.”
Peng Yin, Ph.D., Director, Wyss Institute 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., that use technologies developed in his Wyss lab Institute.
Feng Xuan, Ph.D., was a postdoctoral fellow in Yin’s team and also co-founded 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 group members. Wang is now SPEAR Bio’s acting head of application development.
In SPEAR, which stands for Proximity Sequential Expansion Amplification Reaction, minute amounts of proteins, including NAbs, can be detected by target-binding probes that bind to distinct but proximal sites in the protein structure. This proximal double-labeling event allows the two probes to “shake hands”, their interaction triggering a specifically designed sequential elongation reaction and synthesis of a unique DNA sequence, which can then be amplified and quantified using standard qPCR tools. Importantly, in the absence of detection targets, interaction between free-floating probes prevents synthesis of the complete DNA sequence, significantly reducing background compared to conventional proximity-based assays. SPEAR outperforms other protein detection assays in its combination of exceptional sensitivity, wash-free workflow, and functionality over a wide range of target protein levels (dynamic range) with the ability to be fully efficient at sample volumes of less than 1 uL. The technology was de-risked using the Wyss translation engine, in which it was given the status of first a validation project and then an institute project designed to support the development of high-value technologies with a high potential for market success.
“The exceptional sensitivity in very small sample volumes provided by SPEAR, and the fact that it can be read out using common quantitative PCR equipment, offers unique potential for creating microprobe-based IVF diagnostics that can transform academic and clinical research in multiple disease areas,” Swan said.
Spear Bio is currently applying the assay to quantify SARS-CoV-2 NAb in dried blood samples and thereby aims to facilitate the research of the COVID-19 disease and vaccines. In addition to 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 to go to market,” said Oliver Tassinari, Senior Director of Business Development at SPEAR Bio. “We are now laser-focused on turning the outstanding technical performance of the analysis technology into a satisfying user experience for solving research and diagnostic problems.”
Harvard initially granted SPEAR Bio access to this technology on a non-exclusive basis, for a limited time, 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 the search for 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 a variety of settings, including dried blood samples, opens up entirely new approaches to medical diagnostics that can be used at home as well as in hospital settings conditions. 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 following vaccination or infection during COVID- 19 in the near future,” said Wyss Founding Director Donald Ingber, M.D., Ph.D., who is also Judah Folkman, professor of vascular biology at Harvard Medical School and Boston Children’s Hospital and Hansjörg Wyss, Professor of Bio-Inspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.
Wyss Institute for Biologically Inspired Engineering at Harvard