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Wyss Program Aims to Fast Track New Testing Technologies to Market


NEW YORK – A Harvard University-based diagnostics development program recently emerged from its two-year pilot phase with collaborations already underway to hasten the commercialization of novel testing technologies that could close information gaps in patient care.

Called the Industrial Participant Program and housed within the Wyss Institute for Biologically Inspired Engineering's Diagnostics Accelerator, the initiative has emerged as a full Harvard program with 24 diagnostic companies onboard since being launched as a pilot program in 2021. The program is the industry-facing arm of the accelerator, which is meant to match the firms with Brigham and Women's Hospital clinicians and Wyss bioengineers who are developing new tests and testing technologies.

Rushdy Ahmad, head of the Wyss Diagnostics Accelerator, said the program is meant in part to keep new tests and technologies from dying on the vine by guiding them through biomarker discovery, the development of tests that meet regulatory requirements for specificity and sensitivity, and market guidance to ensure the tests can be sold at prices acceptable to payors. Without such guidance to make sure tests work at scale and in the market, many promising advances spend decades between discovery and commercialization — if they make it that far, he said.

"We're building an ecosystem, a repository, a place of helpful resources for anyone working on diagnostics," Ahmad said.

Wyss officials see potential that the collaborators can help doctors identify or treat conditions including sepsis and other infectious diseases, cancer, neurological and psychological disorders, chronic pain, and metabolic diseases.

Trey Toombs, head of operations for the IPP, said the program leaders are working with clinicians to identify where new diagnostic tests could improve patient care as well as with the IPP companies to identify how collaborations with clinicians and the Wyss Institute could help them bring new tests to market. He said the program helps companies connect with clinicians who can serve as advisers or help the firms run clinical trials and validation studies and engineers who can solve technical problems as part of the process to make sure any products that come through the program will be viable and broadly accessible to patients.

"We want to come up with a solution that's not just specific to an academic medical center that has access to certain resources but something that can also be a solution everywhere — so, hospitals around the world or, maybe, at the point of care in clinics and in patients' hands," Toombs said.

Ahmad said the network of clinicians participating in the program has so far helped identify more than 50 unmet diagnostic needs that IPP members could help solve, and through coordination with Brigham and other hospitals in Harvard's ecosystem, he hopes to identify at least hundreds more that could be brought into IPP members' product pipelines.

Ahmad said the Wyss Institute is accepting IPP members for annual memberships on a rolling basis, although the institute plans to limit membership to 30 companies to ensure the program is selective and provides opportunities to build deep relationships with the firms. Applicants need to be involved in diagnostics development and willing to participate in IPP meetings and events, and the program leaders evaluate potential members through a consultation and company information, including the applicant's diagnostics portfolio.

Among the IPP's initial slate of companies, Sigenex CEO Tan Rasab said his firm wants to bring sequencing to clinics and hospitals without the need for multiroom laboratories using his firm's solid-state microfluidic cartridges, which perform target panel tests in 17-26 hours. He said the company's test to compare variations in BRCA1/2 and several additional target genes can provide results in as little as 24 hours at a cost of less than $150, and added those results can be sufficient to guide chemotherapy. Sigenex joined the IPP while it was in its pilot program in June 2021.

"I wanted to have a sounding board of experts that are available to give us opinions, and that's where the Wyss Institute DxA program came in very handy," he said.

Wyss experts have also helped Rasab understand the principles needed to evaluate his platform and he intends to test his products in Harvard's clinical ecosystem. Becoming associated with Wyss and, through it, Harvard has also helped confer Sigenex the additional credibility needed to establish more partnerships that could lead to other tests being adapted for the firm's platform.

"It actually allows you to open the doors at an early stage to start discussion," he said.

Toombs said the IPP has been helping companies connect with subject experts and opinion leaders that can serve as advisers or help them pursue clinical trials or validation studies, and several companies have sought Wyss technologies and engineering to solve technical problems. Ahmad said the Wyss Institute has also been working with IPP members to connect them with funding sources for sponsored research and pilot projects, the data from which could be used to secure additional federal grants.

Another firm participating in the IPP is Danish startup GLX Analytix, which is developing immunoassays to monitor chronic diseases and treatment response through changing volumes in the blood of glycocalyx, a seaweed-like structure that is on the surface of vascular endothelial cells and is cleaved by immune cells. The firm is developing tests for autoimmune, neurodegenerative, and other neurological diseases.

GLX CEO Brian DellaValle said too few acceleration programs provide opportunities to develop blood-based diagnostics and pathways to reach patients, and he plans to collaborate with the Wyss Institute's network of clinicians to evaluate the company's test on blood samples and run clinical trials. The program also provides opportunities for guidance from key stakeholders, including advisers on reimbursement, listing with the Centers for Medicare and Medicaid Services, and regulatory pathways to market.

"There's tons of energy within the leadership, and it's all about 'How do we get these ideas and these products to patients in a meaningful, rapid, and measurable way?'" he said.

Andrew Levin, CEO of Kephera Diagnostics, said his company joined the IPP pilot program in 2021 to take advantage of the opportunity to work with Wyss' teams as well as position the company to potentially license breakthrough technologies developed through the Wyss Institute, while establishing partnerships for clinical studies of Kephera's upcoming tests. Kephera has not yet commercialized its technology, but it has secured millions of dollars in federal grants in recent years for the development of tests for Chagas disease, Zika virus infection, Taenia solium tapeworm-related neurocysticercosis and taeniasis, Lyme disease, liver fluke infection, and hookworm infection. In March it won a $3 million grant from the National Institutes of Health to finish work on its antigen-based point-of-care Chagas test.

Levin said he recently spoke with Ahmad and Toombs about finding applications and a testing partner for two-minute sample-to-answer antigen assay technology that he thinks could have applications in emergency rooms or situations requiring large numbers of tests.

Through talks with another company at an IPP meeting in June 2022, Kephera also secured a research agreement with the US Armed Forces Research Institute of Medical Sciences (AFRIMS) that will help the firm continue its National Cancer Institute-supported development of ELISA and lateral flow tests for liver fluke infection, which can lead to bile duct cancer and has been linked with elevated cancer rates among military veterans who were stationed in Vietnam and elsewhere in Southeast Asia.

"Our goal is to come up with a test for liver fluke parasite that can be made available commercially to people in the US as well as elsewhere in the world, especially Southeast Asia," Levin said. "We were well on the way to doing that, but we wanted to find partners that could help us by providing the kind of clinical samples that you need to develop and validate this kind of test."

Under the research agreement with AFRIMS, the firm will receive serum samples from patients in Thailand and use those to validate the assay.

"It's an invaluable byproduct of this Wyss Institute program, and this is the kind of collaboration which allows us to fulfil our mission," he said.