Checkable Medical announces first subject enrolled in first of its kind at-home Strep diagnostic and digital engagement platform clinical study
FARGO, N.D., — Checkable Medical, a startup that is seeking to offer unique at-home tests and digital engagement platform for strep throat, today announced the first subject enrolled in their clinical study to prove the safety and efficacy of their at-home strep platform.
Patty Post, founder and CEO of Checkable Medical, is a medical device executive and mother of three who was plagued by having to bring her school-aged children into the clinic time and time again to check for strep. Since there are no at-home strep test platforms that combine a diagnostic test with digital engagement, Patty dedicated her career to creating one so parents can finally check for strep at home.
Patty Post notes, “At Checkable, we know that Mom is the family’s Chief Medical Officer. To be effective in that role, she needs an easy-to-use, high quality at-home strep test for when her family has a sore throat and fever.
At Checkable, we believe you should be able to test for strep at home. We understand the frustration of not knowing whether your kid has a strep infection or not. This is why we’re embarking on a clinical study to gain FDA clearance of our strep diagnostic and digital care experience, so we can be trusted by physicians and parents.
The clinical study has begun with four clinical sites and it is anticipated that it could expand to ten sites in the upcoming months. The initial sites are in South Carolina, New York, and California. Patients who opt into the study will be given the at-home test kit and digital instructions to perform the test, prior to having a standard of 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 and pediatric clinics. Both children and adults may participate in the study.
Checkable’s at-home strep test platform will include the test kit and a digital application that trains home users on how to take a sample, interpret the results, and, once cleared, will connect the user with a telemedicine provider with the ability to prescribe antibiotics to strep positive patients.
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 expects to help reduce the burden on the healthcare system and minimize exposure to people displaying acute symptoms of strep.
Once the Checkable strep testing platform receives regulatory clearance, “You’ll be able to pick up our test at your local pharmacy, use it in the comfort of your own home, and get results in 10 minutes, instead of arranging an appointment with your doctor for a strep test and then waiting hours or even days to get results back,” 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.”
About Checkable Medical
Checkable Medical is empowering consumers to make clinically backed decisions through the availability of at-home testing kits. With plans for at-home test kits available for strep throat and other common illnesses, Checkable Medical tests utilize lateral flow technology to provide affordable and quick results. Based in Fargo, N.D., the Checkable Medical team is made up of scientists, regulators, clinical and technical experts and business leaders committed to rethinking health care. Statements included here are future-looking statements. Our products are currently undergoing clinical studies and will be submitted to FDA for their review. Products will not be sold without FDA clearance.