Curebase and Checkable Medical today announced a joint clinical trial that will assess the efficacy and accuracy of Checkable Medical’s at-home strep throat test kits.
The initial stage of the clinical trial will take place in four clinical regions and will include 100 participants who have a sore throat and will expand to as many as 2,000 participants throughout this strep season. Locations for these sites include North Dakota, South Carolina, New York and New Jersey, tentatively.
Participants who choose to opt-in to the clinical trial will be given a Checkable Medical at-home strep test kit with digital instructions, prior to having a standard of care test performed at a healthcare facility. The study will use clinical practices that typically see walk-in strep patients, including urgent care clinics and pediatrician offices.
Fargo, North Dakota-based Checkable Medical’s self-administered test kits have a mobile application that trains users on how to take a sample, interpret the results and connect them with a telemedicine provider who has the ability to prescribe antibiotics to patients who test positive for strep throat.
“Instead of arranging an appointment with your doctor for a strep test and then waiting hours or even days to get results back, you’ll be able to pick up our test at a local CVS or Target, use it in the comfort of your own home and get results in 10 minutes,” Checkable Medical founder and CEO Patty Post said in a news release. “This helps busy families save time and get results faster while reducing the costs to our healthcare system.”
Curebase will manage the study by activating community-based pediatricians and urgent care facilities. The San Francisco-based company’s platform and virtual site management model are designed to access locations where strep patients are seen. Its decentralized clinical trial model allows for more diverse studies so unique populations can be included.
“Home-based medical tests represent an exciting new evolution in how healthcare is delivered,” Curebase CEO Tom Lemberg said. “There was a time when pregnancy tests and seasonal allergy medications required a trip to the doctor’s office. But healthcare is evolving, and smarter options are becoming reality. That said, studying this population is hard, as they don’t typically show up to research sites to be treated for acute conditions, such as strep. They are more apt to walk-in or make an appointment at their local urgent care or see their trusted pediatrician if they believe their child is sick. We’re excited to leverage our model of bringing clinical research to community-based providers and their patients to make this study possible.”
Trial are expected to begin in November and will be completed by the end of strep season in the spring. Once the clinical trials are successfully completed, Checkable Medical will apply for FDA approval.