Entrepreneurs hope to help parents with over-the-counter strep test

WEST FARGO, N.D. — Patty Post used to dread when one of her three kids woke up with a sore throat.

Her children were at an age when strep seemed to constantly make the rounds at school. And once one of her kids had it, Post knew the bacterial infection would quickly spread to the next child — and the next.

There were weeks in which the busy mom had to repeatedly take off work to drive her three children to a walk-in clinic.

“The inconvenience of it all was so frustrating, because I had clients coming in, I had work to do. I knew what they had,” she says. “Once, when I was sitting at the MinuteClinic, we had been to the clinic three times in one week, and my daughter, she was laying on the bed and she was so sick because we had waited all week, and she was using the test and I thought, ‘Why couldn't this test be taken at home?' This could dramatically change people’s lives.”

That idea changed everything. From that point forward, Post couldn’t stop thinking of ways to develop an easy-to-use, reliable and affordable rapid-strep test for home use.

Then living in Eden Prairie, Minnesota, Post drew on a background that included medical-supply sales and business development to launch a business, Checkable Wellness.

A couple of years ago, she grew so impressed by the supportive business network in North Dakota that she moved the operation to West Fargo, North Dakota.

Today, Checkable Wellness’s strep test is just weeks away from its first clinical trial. If approved by the FDA, the test could hit store shelves by the first quarter of 2023.

Post and Melissa Brandt, the former Downtown Community Partnership head who is now Checkable’s executive director of brand, business and marketing operations, believe this is just the beginning.

They see Checkable Wellness as eventually producing a whole battery of home lab tests, which could detect everything from urinary tract infections and HPV to sinusitis, male/female fertility and even cervical cancer.

“The goal is to totally transform health care, which is what we need right now,” Post said. ”We want this brand associated with the best experience in health care. We’re giving you peace of mind at home.”

Brandt sees Checkable products not only saving families time and money, but also reducing stress on an overburdened health care system.

“How do we get that one person to focus on that person who is actually in dire need — maybe they’re going through a heart attack or stroke or something that could take their life — and how do we take that stress from the system and empower people to do those tests, connected to our health platform, from their homes?” she asks.

Post knows the health care world: She worked for 15 years in medical device sales, then spent two years running business development in the Midwest for a clinical research organization. During that time, she worked with start-ups and strategic med-tech companies such as Medtronic , Boston Scientific , 3M and Abbott , “which is where I learned how medical equipment came from an idea — by a doctor or engineer — and went through that FDA-approval process,” she says.

She moved to a consulting company, where she helped funded start-ups to develop and implement sales strategies and market-development opportunities.

It was during this busy time that Post found herself stuck in a revolving door of pediatrician visits.

It’s also when she was inspired to pursue the home strep test. Post knew the initial strep test was like a home pregnancy test in that it used lateral flow technology — a simple test that could detect a target substance in a sample without need for specialized equipment. Why couldn't strep also be tested at home?

She also learned that false strep scares take a lot of time out of the average health care provider’s day.

She reached out to her contacts at retail stores, the FDA and the med-tech corporations and asked: why an over-the-counter test hadn't yet been developed.

It turned out they had, Post learned, “but they didn’t put anything together that enabled it to be a platform. In other words, it needed someone who really said, ‘This is what the test is, this is how you use it, this is how you collect the sample, this is how you run the test and now you see a doctor.’”

Post decided to not only create that platform, but to back it up with clinical rigor so parents trusted the tests. She also wanted to add tools — from apps and animated usage instructions to 800-numbers and access to virtual care — “to make this a delightful consumer experience.”

In June of 2019, she launched Checkable. Three months later, she had raised $425,000 in external funds to get things going. By December of 2019, she had assembled a small team and they had put the first clinical together and were developing prototypes of the device for the test.

In January 2020, she started hearing rumblings from suppliers of a new strain of coronavirus overseas.

One of her last face-to-face business outings was to the Prairie Capital Summit in Fargo that March. “That was an awesome event, actually,” she recalls. “It introduced me to the market.”

Then COVID shut down the country, “and all clinical research stopped,” she says.

But Post kept right on going.

Even in the thick of COVID, Post made several important connections and decisions.

She learned that North Dakota — a place where people are linked by one or two degrees versus six — was the perfect ecosystem for an entrepreneur. “Where else can you know the commissioner of commerce or the chief security officer for the state?” Post asks. “Where else can you have someone send a text to the governor to ask a question?”

Through Brandt and her Prairie Capital Summit connections, she reached out to the state Department of Commerce, Bio ND, the Small Business Association of North Dakota and Innovate ND and learn more about funding and resources.

“I had the fortunate experience of having investors who understood that and really shepherded me through and jumped all in, with both feet in,” she says.

Adds Brandt: “You can pick up the phone and network with anyone here. People in North Dakota have that community feel and that support for a startup … I think it was incredible. That’s the little golden nugget that North Dakota offers that you don’t find anywhere else in the world.”

By December of last year, Post had moved Checkable Wellness to the Fargo-Moorhead area and established an office along Oak Ridge Loop in West Fargo. Checkable has a staff of seven, with plans to hire four to seven more in the next few months.

The company has already dipped its toes in the home health market by introducing a line of organic, gummy supplements containing beneficial ingredients like melatonin, ashwagandha and collagen.

The supplements, which are made by an established supplement manufacturer in the US, are a way to create a revenue stream for the company while also raising the public’s awareness of the brand as a trusted source for various health care products.

But the company’s No. 1 focus remains on the strep tests.

Under the current model, anyone who suspects strep visits a clinic, where a rapid strep test is given. This test is about 97% accurate, but sometimes the indicators for strep haven’t shown up yet, Post says.

If your test is negative, your health care provider will also administer a throat culture as a safeguard. The culture takes 24 hours but will prove conclusively whether or not strep is present.

With a Checkable Wellness test, the customer will be able to buy a test — for anywhere from $29.99 to $39.99 — from their pharmacy, online or another retail outlet.

The box will contain a swab, a tongue depressor and two tests.

Both paper and digital instructions will be included, so consumers can choose what method works for them best. If they prefer digital, a QR code will take consumers to an animated online training, which shows how to collect a sample.

The initial test will show a result within 10 minutes. If positive, the consumer will be given the option to either join a queue to see a physician or pharmacist via a virtual care platform, which Checkable is also developing, or else be alerted to see their own provider.

If the consumer tests negative, Checkable will send follow-up text reminders asking if the symptoms have subsided or persisted. If the user still feels sick, they can take the second rapid test, which should confirm the presence of strep.

“Wouldn’t it be better to know in 10 minutes?” Post says. “I believe we will catch false negatives faster than with a culture.”

The test will be supported by an 800 help line and money-back guarantee, Post and Brandt say.

“Now you can have two tests and no copay, and you don’t have to take time off from work to take kids in and expose yourself to other germs,” Post says.

They believe people are ready to take some of their own health care into their own hands, as COVID has so changed the traditional model by expanding the use of self-tests and virtual care appointments.

They also believe the home test will free up health care providers to attend to patients with more serious issues.

In a few weeks, Checkable hopes to launch a Phase I trial of 50 to 100 patients at four clinical sites.

When a patient reporting a sore throat enters one of the clinical sites, they'll be asked if they would also like to try the Checkable Wellness test at home. Medical providers will also run the usual test, so the home test’s efficacy can be measured for accuracy.

If their test proves accurate enough to pass this initial trial, it will move to Phase II, which will involve 600 patients at six different sites (including urgent cares in Minot and Bismarck).

If Phase II reinforces the test’s accuracy, trial data will be submitted to FDA for review and ultimately clearance.

Post says the FDA is completely consumed with COVID right now, but she’s feeling confident that her past experience working with the agency will come in handy. “I’ve learned to engage early and often,” she says. “If we submit in August, the thinking is we’d have clearance on the test in the first quarter of 2023.”

“The purpose is to empower people to make evidence-based decisions from home,” she says. “We’re giving you peace of mind at home.”

Learn more about the company at www.checkablewellness.com .