NEW YORK (360Dx) – Life is not the same for young startup diagnostic companies in this "post-Theranos world," but Philadelphia-based Group K Diagnostics and its CEO Brianna Wronko are undaunted, according to early-stage venture accelerator Dreamit.
Wronko said in an interview that the paper or wax-based microfluidic platform that she is developing with a handful of colleagues has the potential to become a cost-effective diagnostic test that can be performed by almost anyone; is easy to transport, store, and ship; and may one day enable testing for several medical conditions at the point of care.
In September last year, Group K Diagnostics began tinkering with the idea of developing a multitest modular point-of-care platform small enough to fit in the palm of the hand that would provide results within 30 minutes, and could eventually handle up to 40 different types of tests.
The company's first assay for liver function is in preclinical trials, but it could be on the market by early next year, Wronko said, adding that the firm expects to begin clinical trials in July and, upon completion, submit the test for clearance to the US Food and Drug Administration.
Group K is planning to launch first in the US "to ensure that our tests meet that high standard," Wronko said, and later in developing countries where inexpensive, point-of-care tests are needed.
Wronko noted that the Group K diagnostic test employs three different types of diagnostic technologies — a lateral immunoflow assay for detecting infectious diseases or other antibody markers; isothermal amplification for diagnosis of sexually transmitted disease and other infections; and molecular diagnostics that determine the quantity of a substance or protein in the analysis of multiple medical conditions.
Samples are loaded to the test by pricking a finger to release blood, or using an eyedropper to place urine at its entry point. Reagents dried on the device are wetted by the blood or urine, inducing a colorimetric change that's read by a smartphone and is reflective of the test result.
Dreamit, also based in Philadelphia, selected Group K as one of eight companies from a list of 300 companies looking to participate in its Spring cohort, a business bootcamp for startups. Dreamit focuses on identifying very early-stage companies and guiding them to market entry. A young company goes through a process that "derisks and accelerates its go-to-market plan," Dreamit Chief Innovation Officer Steve Barsh said in an interview.
Part of the job of a venture accelerator firm is to find "diamonds in the rough that are really early in their maturity," Barsh said. His company looks for a "great idea, and great team, and for something that is a very big opportunity," he said, adding that the concept must be "venture backable."
However, companies just trying to get a foot in the diagnostics industry can expect people to compare them to Theranos, Barsh said.
The once highly valued company with a star-studded board sought to revolutionize the lab testing industry with a novel blood-based testing platform. But a lack of data around its technology and questions about the science behind the company's tests plagued Theranos. Subsequently, federal inspections of Theranos' labs uncovered deficiencies that raised serious concerns about the accuracy of its technology and the company shut down its labs.
Barsh said that diagnostics industry startups, nonetheless, can "draw strength" from the firm's experience by not repeating its errors.
"We were impressed by Group K because within five minutes of meeting them, we said, 'We live in a post-Theranos world, what's your plan?'" Barsh said, adding that, "They replied that they had heard this question before and they presented an impressive plan including how they expected to obtain regulatory clearances. They didn't dance around it."
According to Group K estimates, its cost of materials for the test platform is less than $3.10, and the cost to a customer may be less than $10. However, that could change as the company moves through its four-month business bootcamp with Dreamit, during which the company may fine tune its business plan.
As part of the bootcamp, the firm will present its plans and ideas to potential customers and partners, such as academic medical center Penn Medicine and health insurer Independence Blue Cross.
"We surround them with expertise and put them in front of potential customers to help derisk the business," Barsh said. "Importantly, during these meetings with potential customers and partners, they receive feedback that's critical for an early-stage company about what they need to do and how they need to fit into the ecosystem."
The firm has attracted attention from other investors, Wronko said, adding that she is in discussions with several potential investors about funding.
Mid-Atlantic Bio Angels, which specializes in investing in prescreened early-stage life science companies, named the Group K test "Best in Show" at a 1st Pitch Life Science event in Philadelphia in March, and an audience consisting of around 60 investors and startup staff voted the test as being "most fundable" among several projects presented.
At a 1st Pitch event, early-stage life sciences and healthcare companies give a 15-minute presentation to a panel of experienced life science investors and consultants, and then participate in a 15-minute question-and-answer session with an audience. Presenting companies are invited to hear the panel comment on the company's presentation, business model, and perceived viability in the market.
After Group K completes development on the liver function assay, the team plans to develop a test for cardiac function, Wronko said. They will design the test for d-dimer, troponin I, troponin T, and BNP. Future versions of its platform will handle up to six tests at a time, said Wronko, who spent three years doing research on microfluidics at the University of Pennsylvania, prior to launching Group K.
Beyond cardiac disease, the company expects to expand to tests for HIV, sexually transmitted diseases, other infectious diseases, and topical fevers, she said, adding that the company has identified around "40 different tests that will eventually be in our research pipeline" running on its paper-based microfluidics platform.
Paper-based microfluidic tests, in general, are undergoing extensive research. Microfluidics-based immunoassays, for example, promise significant cost advantages and a reduction in the volume of reagent and sample required for a test when they are compared with traditional laboratory-based test instruments and assays. R&D teams are experimenting with a variety of inexpensive materials, including thermoplastics, glass, and paper, and low-cost fabrication techniques, such as additive manufacturing. Â
Paper-based diagnostic tests are expanding access to care as more people can afford to adopt the tests and are able to apply them, Wronko said.Â