The Brigham Wyss Diagnostic Accelerator aims to develop new diagnostic technologies through close collaborations driven by unmet diagnostic needs

(Boston) – Today Harvard University’s Wyss Institute for Biologically Inspired Engineering and Boston Brigham and Women Hospital (Brigham) announce their newly established Diagnostic Accelerator (Brigham-Wyss DxA). By combining the institutions’ broad clinical and multidisciplinary bioengineering expertise, Brigham-Wyss DxA will enable the rapid development of diagnostic technologies through intensive collaboration in a process driven by previously unmet needs.

Brigham-Wyss DxA presents a new type of research collaboration with the potential to significantly reduce the timeframe for introducing new diagnostic technologies specifically designed to solve high quality clinical problems. The collaborators plan to accomplish this through a formal process in which unresolved diagnostic challenges are identified by the Brigham clinical community, effectively matched with highly appropriate technologies from the Wyss engineering community, and the resulting diagnostic assays jointly validated and optimized in the clinical setting.

The agreement between the Wyss Institute and Brigham was made by the Wyss Institute and the Mass General Brigham Innovation Office with passive support from the Harvard Office of the General Counsel (OGC) and the Harvard Office of Technology Development (OTD).

Diagnostic testing at Brigham is conducted under the terms of the Clinical Laboratory Improvement Amendment (CLIA). This ensures that the test results can be used by clinicians to evaluate how they can help educate their patients’ treatments and lead to better patient outcomes. The aggregated results are also made available to Wyss engineers in an iterative process to provide further information to optimize the tests. The CLIA regulation sets clinical standards for laboratory testing for diagnosis, prevention, and treatment using human specimens that meet their own assessment and approval requirements.

“Traditionally, the road to new diagnostic technology has been long and inefficient, in part because cutting-edge technologies that could in principle meet diagnostic requirements are being developed and commercialized as life science research tools,” said David Walt, Ph.D., who is a member of Core Faculty at Wyss Institute and Professor of Pathology at Brigham. “By creating an initiative that works on the principle of the diagnostic pull rather than the technology push, we hope to overcome the lack of diagnostic skills for some of the most pressing disease areas here and around the world.” Walt is also Hansjörg Wyss Professor of Biologically Inspired engineering at Harvard Medical School (HMS), professor at Howard Hughes Medical Institute, and scientific founder of Illumina, Inc. and Quanterix Corp, and co-founder of several other life science companies.

The Brigham-Wyss DxA is the culmination of a wide range of previous diagnostics-related activities at the Wyss Institute and ongoing Wyss-Brigham interactions that were sponsored by Walt. In 2019, the institute focused its 10th International Wyss Institute Symposium on diagnostic challenges and new technological approaches to overcome them. In the “Wyss Diagnostic Grand Rounds” event series, which is held continuously at the Wyss Institute, individual Brigham clinics have presented Wyss researchers and engineers with unmet clinical needs in their field, which has led to several collaborations. Brigham-Wyss DxA will now streamline this process and further open it up to the clinical community at Brigham.

“We are excited to be working with our colleagues at Wyss on an endeavor that could significantly reduce the timeline for adopting new diagnostic technologies,” said Paul Anderson, MD, Ph.D., senior vice president of research and education at Brigham . “One of the most important aspects of this project is its potential impact on patient care – information from novel diagnostic tests could expedite and guide the timely treatment of our patients.”

The Brigham-Wyss DxA uses an online portal to solicit suggestions from clinical advocates for much-needed diagnostic tests to improve clinical decision making and outcomes, including required clinical specifications such as form factor, clinical sensitivity and specificity. A Clinical Advisory Board made up of Harvard-affiliated and external clinicians and entrepreneurs will select the most promising. These will be answered with research efforts at Wyss DxA’s Biomarker Discovery Facility to identify the biomarkers and analytical performance criteria required to meet the clinical specifications of the diagnostic tests. Wyss technology developers will then compare clinical requirements and biomarker measurements with existing technologies or develop new technologies that effectively meet diagnostic needs. In the clinical trial phase, diagnostic tests and devices that meet the required stringent criteria are validated under CLIA conditions at the Brigham Clinical Laboratory Diagnostic Accelerator, where Wyss staff train Brigham’s clinical staff in their use.

“We believe the Brigham-Wyss DxA can be a powerful tool for delivering much-needed diagnostic capabilities to patients in need in a much shorter timeframe and reducing the often staggering medical costs of misdiagnosis,” said Rushdy Ahmad, Ph.D. , Senior Staff Scientist and Co-Leader with David Walt from Brigham-Wyss DxA. Ahmad has extensive expertise in biomarker discovery and, together with Walt, coordinates activities related to Brigham-Wyss DxA and other initiatives at the Wyss Institute. “As a new model, it has the potential to attract support from industrial partners, philanthropic organizations, government and international agencies, non-governmental organizations and other employees,” he added.

“With this new cross-institutional, multidisciplinary initiative, we hope to bridge the almost ubiquitous diagnostic gap between realistic clinical requirements and innovative technology developers by creating the shortest path between these worlds, providing patients with novel diagnostic options faster than ever before.” If successful, our model could be a model that reverberates within and beyond the Harvard ecosystem, ”said Donald Ingber, MD, Ph.D., founding director of Wyss, who is also a Judah Folkman Professor of Vascular Biology at the HMS and Boston Children’s Hospital, and Professor of Bioengineering at Harvard John A. Paulson School of Engineering and Applied Sciences.

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PRESS CONTACT

Wyss Institute for Biologically Inspired Engineering at Harvard University

Benjamin Böttner, [email protected] , +1 617-432-8232

Brigham and Women’s Hospital

Haley Bridger, [email protected] , +1 617-525-6383

MULTIMEDIA AVAILABLE

The Wyss Institute for Biologically Inspired Engineering at Harvard University uses nature’s design principles to create bio-inspired materials and devices that transform medicine and create a more sustainable world. Wyss researchers develop innovative new technical solutions for healthcare, energy, architecture, robotics and manufacturing that are translated into commercial products and therapies through collaboration with clinical researchers, corporate alliances and the creation of new start-ups. The Wyss Institute creates transformative technological breakthroughs by conducting high-risk research and breaking disciplinary and institutional barriers, working as an alliance that includes Harvards 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, University of Massachusetts Medical School, Spaulding Rehabilitation Hospital, Boston University, Tufts University, Charité – Universitätsmedizin Berlin, Universität Zürich and Massachusetts Institute of Technology. Further information can be found at http: // wyss.Harvard.edu.

Brigham Health , a global leader in creating a healthier world, consists of Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, Brigham and Women’s Physicians Organization, and many related facilities and programs. With more than 1,000 inpatient beds, approximately 60,000 inpatient stays and 1.7 million outpatient visits per year, Brigham Health’s 1,200 doctors provide patients on site, in the region and around the world with expert care in virtually all medical and surgical specialties . As a global leader in basic, clinical and translational research, Brigham Health employs nearly 5,000 scientists, including investigators, renowned biomedical researchers and faculties, with over $ 700 million in funding. Brigham’s medical supremacy dates back to 1832 and today, with 19,000 employees, that rich history is the foundation of its commitment to research, innovation and community. Boston-based Brigham and Women’s Hospital is a Harvard Medical School teaching facility dedicated to educating and educating the next generation of healthcare professionals. For more information, resources, and to follow us on social media, please visit brighamandwomens.org.

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