By Deborah Borfitz
November 5, 2019 | Companies looking to commercialize rapid diagnostics technologies might want to borrow from the playbook of those who successfully brought their point-of-care (POC) products to market—specifically, TechLab’s C. Diff Quik Chek Complete and ID NOW (formerly Alere i), says Ryan Schmidt, vice president of sales and marketing at startup Click Diagnostics and previously vice president of infectious disease marketing with Alere. Even snags encountered along the way can provide valuable lessons on the importance of soft launches and “thinking holistically” about stakeholders and customer interactions.
Schmidt dove into details about the two POC tests at the 2019 Next Generation Dx Summit. He began by reciting the World Health Organization definition of a POC test as being affordable, sensitive, specific, user-friendly, rapid, equipment-free and delivered to end users (aka ASSURED). Time-wise, POC time means under 30 minutes when the patient is still with the physician, he adds.
Clostridium difficile (C. diff) is a gnarly, potentially recurrent disease that can quickly result in death if not treated promptly, says Schmidt. Before C. Diff Quik Chek Complete hit the market, diagnosticians were often confused by a positive result because molecular assays couldn’t distinguish C. diff carriers from those with active disease.
The product was unique and needed a “signature story,” Schmidt says, which began by embracing the inertia around antibiotic stewardship. At the time, the number of hospitals with organized programs to reduce antibiotic use was stunningly low because the conversation didn’t include the “right people”—leaders in infection protection, pharmacy, IT, and emergency and infectious disease medicine, as well as the lab.
No one thought to consult a gastroenterologist, as TechLab did when it reached out to Mark Mellow, M.D., a fecal transplant specialist at Integris Health whose C. diff patients were weeping in gratitude for the treatment option, says Schmidt. Mellow is the one who suggested and organized the health economics study that became the chief selling point on the POC test with even the large commercial reference labs.
Publication of the paper turned into a “massive opportunity” that involved large-scale training of hospital lab staff on the 25-minute C. Diff Quik Chek Complete test, Schmidt says.
The ID NOW platform, a molecular system for the detection of infectious diseases, is part of Abbott’s growing footprint in the lateral-flow immunoassay business, says Schmidt, the strategy being to “protect and build its install base.” Leaning on the right distribution partners at the right time has been key to its success. But after-purchase support and training wasn’t as easy as expected, meaning more usability testing was needed, and in some labs contamination control has been an issue.
Schmidt’s advice for companies is to consider an early-access program, pick key opinion leaders carefully, invest in education, ask POC coordinators what they need and “know your limits.” The future of rapid diagnostic technologies could include roles for telephonic support, home testing, and even smart devices such as Alexa and Nest, he says. “We want to democratize it for those who need it the most.”