Telehealth is having its moment as the COVID-19 pandemic continues. Patty Post, founder and CEO of Checkable Medical, is developing at-home strep and COVID-19 tests.
Patty Post found herself sitting at her third doctor’s office visit in a week. Two of her kids were diagnosed with strep throat a few days earlier. When her third child became sick, she knew it had to be strep, too, but the pediatrician said that it had to be diagnosed by a doctor before they could prescribe an antibiotic.
“We were sitting there in the Minute Clinic and the nurse was taking the sample and the entire experience was about an hour and 20 minutes long,” Post told Medical Design & Outsourcing. “They were backed up. As she was taking her sample, I happened to go on Amazon and see that the exact McKesson test that she was using was available on Amazon, so I bought one.”
The test she found online was a clinical-grade test, leaving Post puzzled about why it was available on Amazon. As a veteran in the sales, marketing, clinical regulatory and product development aspects of the medtech industry, Post consulted pediatricians, regulators and manufacturers for a better understanding of the at-home strep test market.
Filling the gap
“I realized that a gap was there,” Post said. “Certainly, there’s a lot of parents that would love to diagnose a sore throat without having to go into the doctor’s office. It turns out that over 75% of the time, when you go to the doctor for a sore throat, the strep test is negative. So, a lot of parents end up utilizing healthcare just to be sure because they can’t take another day off of work.”
While the Centers for Disease Control and Prevention doesn’t track non-invasive group A strep infections, it estimates that three in 10 children with a sore throat have strep and one in 10 adults with a sore throat has it, too.
For nine months, Post researched strep tests to understand if there was a product-market fit and what it would take to create a single-use, reproducible test. Working with engineers, Post launched Checkable Medical in February 2019 and started working at the Eden Prairie, Minn.-based company full-time by May of the same year.
Checkable Medical is currently developing strep test diagnostic technology. Still in its R&D stages, the company isn’t taking orders but has started working on distributing an at-home COVID-19 antibody test.
“We partnered with a company for the strep assay as we had decided not to create an assay from scratch because there are so many credible ones out there. In March, our partner got in touch with me and asked if we would be interested in doing an at-home COVID-19 antibody test that paired with our technologies,” Post said. “What we’re doing right now is, we’re going through the process of first doing a usability study of that COVID-19 antibody test, and then we’re running a clinical trial.”
The COVID-19 and strep tests both use lateral flow technology. The COVID-19 antibody test itself is a finger-stick test. It comes in a box with a lancet, two small tubes, two alcohol swabs and a single-use buffer. The paper-based technology works by putting one drop of blood onto the test with two drops of the buffer. Within 10 minutes, the user should have the results.
“Antibody tests are what should be used for population health purposes,” Post told MDO. “It’s the diagnostic that is used to tell you if your body has been exposed to COVID-19 and whether you’re in the middle of your infection or if you’ve already gone through it.”
Stepping onto the telehealth path
As the COVID-19 pandemic continues, telehealth will continue to play a major role in healthcare. The Cleveland Clinic predicted at its 18th annual Medical Innovation Summit on October 6 that telehealth will continue to be a disruptor into 2021 as the technology becomes accessible to more communities.
Checkable Medical will offer every test buyer a telehealth visit to allow the patient to speak with a physician, according to Post.
“What’s interesting with this telehealth movement is everyone was saying, ‘It’s going to take a massive consumer behavior change. How are you going to do that? How are people going to become aware of this?’ And now people are asking for it because their kids are sick,” she said. “The last place you want to bring them into is a healthcare facility when you don’t know what’s in the air or what’s on the surface. The objection has changed dramatically.”
