November 11, 2021

WE-REACH support helps team pivot from academia to small business venture

Flipping the switch from professor to entrepreneur — where one endures intense pace and high-pressure stakes— is a daunting proposition. Having access to a team of experts and services through Washington Entrepreneurial Research Evaluation & Commercialization Hub (WE-REACH), a group dedicated to transforming novel breakthroughs into innovative products, can make a huge difference.

Take Dr. Barry Lutz, an associate professor of bioengineering at the University of Washington (UW), who develops point-of-care diagnostics for infectious diseases and is a co-investigator in the Seattle Flu Study, a nationally renowned multi-institutional pandemic surveillance platform. When the pandemic hit in early 2020, one of Lutz’s colleagues, UW staff scientist Enos Kline, believed their technology could successfully be adapted to provide a point-of-care diagnostic test for COVID-19.

“When we realized the scope of COVID-19, we wanted to do something to contribute,” said Lutz. Although he had worked on other product teams that had received venture funding, this time things were different: the potential was enormous and the urgency unprecedented.

Lutz and his team were seeking funding and landed on the National Institutes of Health (NIH) initiative—Rapid Acceleration of Diagnostics, or RADx^SM.    That’s where WE-REACH, a part of a NIH-supported network charged with accelerating the translation of biomedical discoveries into commercially viable products to impact health and patient care, entered the picture.  WE-REACH Executive Director Rodney Ho, who was well aware of the work in Lutz’s lab, encouraged him to seek RADx support through WE-REACH.  Working under a tight deadline and with limited resources, they responded.  Through WE-REACH guidance, RADx awarded $250,000 to continue development of their COVID-19 test.

With funds in hand, coupled with guidance from WE-REACH staff and consultants including NIH Investor-in-Residence Steve Flaim, the Lutz team set out to tackle the myriad variables critical to bringing their product to market. First off: framing the project milestones.

“I think the assistance in outlining the milestones for this project was the most important WE-REACH resource we used,” said Lutz. “Not only did we need help articulating our benchmarks, but also figuring out the process for the new application, which Dr. Ho and the WE-REACH team facilitated with support from RADx.” Important questions included: What documents should the team submit? What are the correct steps to take? Who is the customer and what are the right distribution channels? “We went back and forth drafting our milestones and refining the technical content,” Lutz explained.

Three key milestones for the project were identified and set to an aggressive six-month timeline. “First, we needed to perfect the data package so we could show that the product worked and was meaningful,” Lutz explained. Second, they needed to translate their laboratory method into a manufacturable format. “We had produced the reagents in our lab but needed to get them to a stage where we could hand them off to a manufacturer,” he said.

The third milestone revolved around hardware. Although a prototype device had been developed as part of previous projects in the Lutz lab, the detector needed to be refined for this application. “We also needed to be able to manufacture the test kit at a competitive price,” said Lutz. The team ended up doing a complete redesign before they were ready to advance.

Within three months, an innovative prototype device was ready. Called the AscensioDx™, the detector provides a rapid, highly accurate, easy-to-use, affordable test for COVID-19. It was designed for physicians’ offices, pharmacies, and community clinics as a sort of “portable lab” to detect results without submitting the samples to a larger central facility, as these laboratories can have delayed results, especially in rural or low-income areas.

As part of the WE-REACH Biomedical Innovation Bootcamp, an intensive four-week program, the Lutz team gained insight into consumers’ perceptions of COVID-19 testing. The experience enabled Lutz to better understand today’s business and commercialization landscape and, along with RADx advisors, helped smooth the way for advancing the project.

“Thinking as a researcher is completely different from thinking as an entrepreneur,” Lutz said. “Academics tend to have a narrow focus on technology development, and there are so many factors involved with launching a new product, such as supply chain and manufacturing issues, finding vendors, and understanding regulatory matters. Without the support and guidance from WE-REACH, our trajectory would have been much slower — and it may not have happened at all.”

Recently, Lutz, along with Bob Atkinson and Minh Duong, co-founded Anavasi Diagnostics, which will manufacture the AscensioDx Molecular Detector for COVID-19. Nelson Patterson, a medical device executive with decades of experience, joined the team as a consultant and later as its CEO. Anavasi is now hiring staff and adding manufacturing capability so that the product can launch as soon as  authorization from the U.S. Food and Drug Administration is received.

“This has been an exciting time for us,“ said Lutz. “The pieces came together quickly, and we lost no time going from step to step. The more we told our story, the more we inspired people to join our effort.”

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WE-REACH is one of the NIH Research Evaluation and Commercialization Hubs (REACH) and is supported by NIH Grant U01HL152401. RADx Tech supported this project through a supplement funding award to WE-REACH.

Anavasi is supported by the NIH Rapid Acceleration of Diagnostics (RADx^SM) initiative and has been funded in whole or in part with federal funds from National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92022C00005