During Phase 3, six teams had access to webinar modules, mentorship, and networking opportunities to help them plan clinical performance studies for validating their proposed solutions. The goal of the $10+ million multiphase competition is to nurture the development of diagnostics toward Food and Drug Administration (FDA) review.
The LymeX Diagnostics Prize thanks the Phase 3 subject matter experts for providing guidance on clinical study design, regulatory engagement, biostatistics, and product development:
- Elliot Cowan, Ph.D., Founder and Principal, Partners in Diagnostics LLC
- Andrew DiMeo, Sr., Ph.D., Founder and Health Innovation Consultant, DiMeo LLC
- Tamara V. Feldblyum, MS, Ph.D., Senior Regulatory Consultant, Partners in Diagnostics LLC
- Peter Kupchak, Ph.D., Statistical Consultant, Partners in Diagnostics LLC
- Rajat Mukherjee, Ph.D., Founder and Chief Statistical Consultant, MuSigmas Consultants
As the LymeX Diagnostics Prize gears up for Demo Day, the teams are reflecting on their experience in the competition. Read on to learn more about Phase 3 and their work.
Designing clinical studies for future FDA submission
Early diagnosis is critical, because the disease can spread throughout the body if the bacterial infection is left untreated — but there is currently no FDA-cleared test for active infections. The LymeX Diagnostics Prize team designed Phase 3 support to help teams prepare for the complex FDA clearance process while meeting patient needs for diagnostics.
“Of our planned verification and validation activities, we view the clinical study to be the most challenging to design and execute,” noted HelixBind Chief Business Officer David Steinmiller. “We were able to review and refine our plan for this study with experts to whom we got access through the LymeX Diagnostics Prize and made major improvements to the design of our study. The most helpful feedback involved biostatistics, especially how to power our study for negative percent agreement with our comparator method.”
By using an open innovation structure, the LymeX Diagnostics Prize provides cash prizes alongside critical non-monetary support to accelerate new ideas. “As an academic team, we don’t have access to experts in regulatory affairs, and the conversations we had with the subject matter experts have really helped to demystify the process and plan our presubmission discussions with the FDA,” said Tufts University Lyme Disease Initiative Director for Translational Research Dr. Peter Gwynne. “These office hours delivered exactly the kind of support we needed.”
Drexel University College of Medicine Associate Professor Dr. Mary Ann Comunale agreed. “Engaging with folks that have so much experience with the FDA helped to understand what kinds of things the FDA will be focused on. Making sure teams are providing clarity and details in submissions will enable the FDA to provide a more directed and applicable response, saving time downstream.”
Preparing for market with key industry support
With an estimated 476,000 Americans diagnosed and treated for Lyme disease each year, any future diagnostics need to be designed for scaling across laboratory settings. In Phase 3, industry supporters Labcorp and Quest Diagnostics are providing non-financial in-kind support, helping teams deepen their understanding of the diagnostics industry, how clinical laboratories operate, and how to work with commercial laboratories. At the virtual Industry Day event in August, Phase 3 teams heard from industry clinical laboratory subject matter experts. Each team also had the opportunity to visit clinical reference laboratory facilities to learn more about the clinical laboratory environment and their workflows, materials, and instrumentation.
“The engagement with Labcorp and Quest Diagnostics was especially valuable for the BlueArc team, as we envision our diagnostic test being performed in a centralized testing laboratory like those operated by Labcorp and Quest,” said BlueArc Biosciences Inc. Founder and CTO Mark Eshoo, Ph.D. “The engagements both by the virtual Industry Day and physical site visits provided valuable feedback from the end-user of our diagnostic and helped our team reaffirm that we are pursuing the correct path for our diagnostic test.”
HelixBind’s David Steinmiller concurred. “The most important learning from the virtual Industry Day involved the logistics of testing at both companies. Specific information about shipping conditions and preferred sample stability requirements was especially valuable.”
At the event, speakers discussed critical factors for successful commercializations, including business models and go-to-market strategies. “Industry Day was a really valuable insight into the scale of these commercial diagnostic labs,” Tufts University’s Dr. Peter Gwynne said. “Speaking to those companies gave us a lot of important context about our target market and a better understanding of the work we need to do to engage them.”
Accelerating innovation through cash prizes and expert support
The LymeX Diagnostics Prize is helping entrants overcome diagnostic development barriers by providing funding and technical assistance while fostering cross-disciplinary collaboration and partnerships. “The LymeX Diagnostics Prize has brought together the most incredible panel of experts from every facet of device development,” said Drexel University’s Dr. Mary Ann Comunale.
Through the competition, successful diagnostic tests will move toward FDA submission and clearance with a greater level of maturity, sensitivity, specificity, and potential for patient impact than would otherwise be possible. “By bringing together stakeholders, developers, and thought leaders, the competition helped establish a target product profile,” explained HelixBind’s David Steinmiller. “A concrete TPP, along with confidence that a market exists for that product, is what developers require to embark on serious efforts to create new and innovative diagnostics.”
“The LymeX Diagnostics Prize has given us access to expertise and resources covering the whole translational research pipeline to support us from discovery to regulatory approval,” added Tufts University’s Dr. Peter Gwynne. “The advice we’ve been able to get and the knowledge we’ve gained has allowed us to restructure the development of our test from an academic research project into a product-focused assay development pipeline.”
“We cannot say enough about how important the LymeX Diagnostics Prize has been for us to pursue our efforts for a more sensitive and specific direct diagnostic for early Lyme disease,” BlueArc BioScience’s Mark Eshoo said.
Teams preparing final Phase 3 submissions
In October, each team will submit a concept paper that details FDA engagement undertaken and implementation of feedback received, new or improved analytical performance data, final clinical performance study protocol, and progress achieved in planning and initiating its clinical performance study. In November, the Phase 3 teams will then present and publicize their diagnostic tests at Demo Day, showcasing their proposed solutions to stakeholders from government and industry, including clinician and consumer organizations. Phase 3 will award up to six prizes of $350,000 each.
The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation. Neither Labcorp nor Quest Diagnostics are providing any remuneration to the awards.
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