SAN FRANCISCO and FARGO, N.D., Oct. 19, 2021 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Checkable Medical, a startup that offers unique at-home tests for strep throat, today announced a joint clinical trial designed to confirm the efficacy and accuracy of Checkable's at-home strep throat test kits.
The initial stage of the clinical trial will involve four clinical regions, will initially include 100 participants who present with a sore throat and then expand to as many as 2,000 participants over the course of this strep season. Tentative locations for these sites include North Dakota, South Carolina, New York, and New Jersey. Patients who opt in to the study will be given the at-home test kit and digital instructions, prior to having a standard a care test done at the healthcare facility. This study will make use of clinical practices that commonly see walk-in strep patients, including urgent care clinics and pediatrician offices. Both children and adults may participate in the joint trial.
Checkable's self-administered test kit comes with a mobile application that trains home users on how to take a sample, interpret results and then connect with a telemedicine provider with the ability to prescribe antibiotics to step positive patients. Curebase will manage the study by activating community-based pediatricians and urgent care facilities that typically see step patients versus traditional research sites. Curebase's technology platform and virtual site management model are uniquely designed to access locations where strep patients are being seen.
"Home-based medical tests represent an exciting new evolution in how healthcare is delivered," said Tom Lemberg, founder and CEO of Curebase. "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."
Caused by streptococcus pyogenes, a bacterium that is extremely contagious, strep throat can lead to sinus, tonsil and ear infections and inflammatory illnesses such as scarlet fever and rheumatic fever. Children are particularly vulnerable to strep infection. By providing at-home tests, Checkable Medical helps to reduce the burden on the healthcare system and minimize exposure of the population to people displaying acute symptoms of strep.
Trials will begin in November and be complete by the end of strep season next spring. Once clinical trials are successfully accomplished, Checkable Medical will seek Food and Drug Administration approval for its at-home testing device.
"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," said Checkable founder and CEO Patty Post. "This helps busy families save time and get results faster while reducing the costs to our healthcare system."
Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics and large academic research sites.
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Curebase's vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools, including all-in-one eClinical software and virtual research sites, designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community. For more information, please visit www.curebase.com.
About Checkable Medical and Checkable Wellness
Checkable Medical, a start-up based out of North Dakota, is developing a first-of-it-kind at-home rapid strep test allowing parents, health plans and employers to deliver healthcare directly to people's homes for easy self-collection and rapid results. The solution uniquely combines at-home diagnostics, digital training, telehealth and e-prescriptions to drive more engagement, closing gaps in care and improved outcomes. As a parent and a patient, Patty Post founded Checkable Medical to help families save time and reduce the cost of care through innovative at-home testing kits. Checkable Medical expanded its product line in 2021 with its Checkable Wellness multivitamins to offer total body support and health. Optimize your health, healthcare begins at home!