New Brigham–Wyss Diagnostic Accelerator could enable fast creation of diagnostic technologies

Today, the Wyss Institute for Biologically Inspired Engineering at Harvard University and Boston's Brigham and Women Hospital (Brigham) announce their newly founded Diagnostic Accelerator (Brigham-Wyss DxA). By combining the institutions' broad clinical and multi-disciplinary bioengineering expertise, the Brigham-Wyss DxA will enable the fast creation of diagnostic technologies through deep collaborations in a process driven by previously unmet needs.

The Brigham-Wyss DxA presents a new type of research collaboration with the potential to significantly compress the timeframe for introducing new diagnostic technologies specifically developed to solve high-value clinical problems. The collaborators plan to achieve this through a formal process by which unmet diagnostic challenges are identified by the Brigham clinical community, effectively matched with highly appropriate technologies created by the Wyss' engineering community, and the resulting diagnostic assays jointly validated and optimized in clinical settings.

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

Diagnostic testing at the Brigham will be performed under Clinical Laboratory Improvement Amendments (CLIA) conditions. This will ensure that the test results may be used by clinicians to evaluate how they can help inform their patients' treatments, and result in better patient outcomes. Aggregated results will also be provided to the Wyss engineers in an iterative process to further inform the tests' optimization. CLIA regulation sets clinical standards for laboratory testing for diagnosis, prevention, and treatment using human samples that align with its own evaluation and approval requirements.

Traditionally, the path for a new diagnostic technology has been long and inefficient, partly because cutting-edge technologies that in principle could address diagnostic needs are developed and commercialized as life sciences research tools. By founding an initiative that works on the principle of diagnostic pull rather than technology push, we hope to overcome the dearth of diagnostic capabilities for some of the most pressing disease areas here and around the world."

David Walt, Ph.D., Core Faculty Member, Wyss Institute and Professor of Pathology, Brigham and Women Hospital

Walt is also the Hansjörg Wyss Professor of Biologically Inspired Engineering at Harvard Medical School (HMS), a Howard Hughes Medical Institute Professor, and the scientific founder of Illumina, Inc. and Quanterix Corp, as well as co-founder of multiple other life sciences companies.

The Brigham-Wyss DxA is the culmination of a broad range of past diagnostics-related activities at the Wyss Institute and ongoing interactions between the Wyss and the Brigham fostered by Walt. In 2019, the Institute focused its 10th International Wyss Institute Symposium on diagnostic challenges and new technological approaches to address them. In the "Wyss Diagnostic Grand Rounds" series of events held continually at the Wyss Institute, individual Brigham clinicians have been presenting unmet clinical needs in their fields to Wyss researchers and engineers, which has resulted in multiple collaborations. The Brigham-Wyss DxA will now streamline this process and open it up further to the clinical community at the Brigham.

"We're thrilled to be collaborating with our colleagues at the Wyss on an endeavor that could significantly compress the timeline for introducing new diagnostics technologies," said Paul Anderson, M.D., Ph.D., Senior Vice President of Research and Education at the Brigham. "One of the most significant aspects of this project is its potential impact on patient care — information provided by novel diagnostic tests could accelerate and guide the timely treatment of our patients."

The Brigham-Wyss DxA uses an online portal to solicit proposals from clinical advocates for urgently needed diagnostic tests to improve clinical decision making and outcomes, including the required clinical specifications, such as form factor, clinical sensitivity and specificity. A Clinical Advisory Board comprised of both Harvard-affiliated and external clinicians and entrepreneurs will select the most promising ones. These will be responded to with a research effort at the Wyss DxA's Biomarker Discovery Facility to identify the required biomarkers and analytical performance criteria to meet the diagnostic tests' clinical specifications. Wyss technology developers will then fit the clinical requirements and biomarker measurements with existing technologies or create new ones that can effectively address the diagnostic need. In the clinical testing phase, diagnostic tests and devices that pass the required rigorous criteria will then be validated in the Brigham Clinical Laboratory Diagnostic Accelerator under CLIA conditions, where Wyss staff will train Brigham clinical staff in their use.

"We believe that the Brigham-Wyss DxA can be a highly effective instrument to bring much needed diagnostic capabilities in a much shorter time-frame to patients in need and reduce often staggering medical costs from misdiagnosis," said Rushdy Ahmad, Ph.D., Senior Staff Scientist and Co-lead with David Walt of the Brigham-Wyss DxA. Ahmad has strong biomarker discovery expertise and, along with Walt, coordinates activities related to the Brigham-Wyss DxA and other initiatives at the Wyss Institute. "As a new model, it has potential to attract the support from industry partners, philanthropic organizations, government and international agencies, non-governmental organizations, and additional collaborators," he added.

"With this new cross-institutional, multi-disciplinary initiative we hope to bridge the almost ubiquitous diagnostic chasm between realistic clinical needs and innovative technology developers by creating the shortest distance path between these worlds that will bring novel diagnostic capabilities to patients faster than ever before. If successful, our model could set an example further reverberating within and far beyond the Harvard ecosystem," said Wyss Founding Director Donald Ingber, M.D., Ph.D., who is also the Judah Folkman Professor of Vascular Biology at HMS and Boston Children's Hospital, and Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.