On April 15, 120 people representing federal funding agencies, philanthropies, venture capital firms and large companies gathered at the Johns Hopkins Bloomberg Center in Washington, D.C., all poised to learn about — and get hands-on experience with — point-of-care diagnostic platforms for infectious diseases in early-stage development. The Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases (CIDID) convened the Beltway Innovation Showcase to help bridge the gap — the so-called valley of death — between a prototype rapid diagnostic device that shows promise and commercialization of that device. The event illustrates how concept evaluation, funding and matchmaking can accelerate the path of getting ideas to market, and why that matters for public health.

Since 2007, CIDID has been a member of the Point-of-Care Technologies Research Network, or POCTRN. In addition to CIDID, network members include a coordinating center, Cimit (Massachusetts General Hospital), and five other centers: C-THAN (Northwestern University), CITEC (Rice University), CAPCaT (University of Massachusetts), PORTENT (Cornell University), and ACME (Georgia Institute of Technology and Emory University). CIDID, here at The Johns Hopkins University, is the oldest center, and it offers expert consultation, access to clinical specimens, objective platform evaluation, and design and usability advice to developers in an effort to avoid costly reworks.

Funded by a U54 grant on which Yuka Manabe, M.D., and Susan Tuddenham, M.D., M.P.H., are co-principal investigators, CIDID has evaluated diagnostic platforms from 70 companies in the past three years alone. “We’re interested in tests that people can buy off the shelf as self-tests, like a pregnancy test,” Manabe, director of CIDID notes. “Tests for gonorrhea, chlamydia, trichomonas, HIV, syphilis, hepatitis C — these are all things that our center has worked on.” With the consumer in mind, CIDID is interested in products that are affordable.

The U54 funding mechanism allows CIDID to offer small, six-month awards to help companies address technical barriers and accelerate the timeline to clinical readiness. “It’s a way for them to get to the next level and get what we call Series A funding,” Manabe explains. “First, you tend to get money from friends and family or angel funding, then you move on to venture funding. If you think things are going well, you try to get what we call Series A funding, which is usually to fund a clinical study.”

The Beltway Innovation Showcase featured an exhibit area for platform demonstrations, and five companies were invited to deliver five-minute pitches. Manabe says that the pitches focused on the story of the unmet need that the prototype solves. “Developers needed to address many key points,” she notes. “What’s the landscape? How do they fill that unmet need, and how do they fit into the landscape? Why would someone want to invest in them, and what are they looking for?” 

Pitches also focused on the ask — some companies need partners, some need money and some need expertise — and what the future of the technology holds. “Maybe right now, you have a test for chlamydia and gonorrhea, two sexually transmitted infections. Maybe after that, you know that you want to go to respiratory infections,” Manabe says. “The pitches provided a sense of what platforms could do in the future. It looks like this today, and this is what we’re aiming for in the future.”

The developers who pitched were not selected at random — they represented five companies that had received CIDID grants for promising ideas and guidance on changes to the technology that would increase the likelihood of crossing the FDA regulatory finish line. The showcase was designed specifically to get developers with promising products that CIDID had evaluated together with potential funders interested in acquiring the technology, or investors to fund the next steps of development or address technical challenges. 

“We also had people attend who offer all kinds of assistance with device development,” Manabe says. “If you want to make a prototype, you might need someone to make that first device for you, so they make prototypes. You give them the design, they try to make it, and they tell you what the problems are.” There were also people in attendance who work specifically on value manufacturing. “For instance, there’s an expensive way to make a piece of plastic, and a less expensive way. And how much injected molded plastic do you need? What kind of design changes could you make to produce the device more frugally?” Manabe notes.

The ultimate goal for CIDID in advancing development of diagnostic platforms is to speed up the timeline from concept to FDA approval, so that effective and affordable rapid tests reach consumers, allow them to test themselves and be treated earlier, and mitigate the spread of infectious diseases. Manabe explains that while the work is, of course, data driven, it’s also practical. “You can affect many more people than an idea that makes a good peer-reviewed paper. I think you have the possibility of touching more lives. And truthfully, I think everybody who goes into academia doesn’t go into it selfishly; they go into it to do something good for somebody else.”