Welcome to “Innovators & Insights,” an interview series hosted by Chris Strohsahl, President & CEO of Drummond Scientific, where leading minds in the life sciences industry share the latest industry trends, groundbreaking innovations, and pivotal stories from their professional journeys. In this edition, Chris spoke with Ken Mayer and Heather Lucore of HealthCheck, a company partnering with diagnostic developers to advance virtual healthcare and at-home diagnostics with custom, AI-powered solutions. From regulatory approval to market distribution, Ken and Heather explore the challenges behind decentralizing diagnostics and the importance of helping rural and underserved populations access the care they need, where and when they need it most.
Chris Strohsahl: To start us off, I’d love to hear a quick elevator pitch about who you are, how you got here, and what got you working together at HealthCheck.
Heather Lucore: I spent about 19 years of my career with Quest Diagnostics, during which I co-led COVID-19 commercialization during the pandemic. In addition, I also co-lead the Home Testing Special Interest Group at the American Telemedicine Association.
Ken Mayer: I’m the founder and CEO of HealthCheck, though I started my career in entertainment and marketing.
One night, after reading an article about the growth of STD rates, I had the idea for an app that could let people show their verified STD status on their phones. That was when I really caught the healthcare bug. I became passionate about using decentralized care to increase care accessibility, reduce costs, and improve health outcomes through digital health apps.
CS: So, what’s the true origin story behind HealthCheck?
KM: In early 2020, after about a year of due diligence, Mayo Clinic invested in Safe Health, which we spun out of Safely, the safe sex app. After several years of rapid growth, I decided to step away from the business and create a new company that could operationalize the technology and standards we’d developed at Safe Health.
HL: HealthCheck’s mission is to bring telehealth testing to the average Joe. Throughout the U.S., people need access to telehealth testing that connects key information, like their health records. Right now, testing often happens in a vacuum, and if it’s performed at home, the results don’t go anywhere.
CS: You really hit on some of the core problems with traditional diagnostics. To channel my inner Brené Brown, how do you “paint done”? What is success for HealthCheck?
HL: I’m not sure that you can “paint done” per se. However, “good” is out there, and “good” means bringing healthcare and diagnostic testing to areas with healthcare deserts. In Texas, for example, millions of veterans live three or more hours from a healthcare provider, and we have the power to close that gap.
KM: At Safe Health, we worked with the Food and Drug Administration (FDA) to develop standards and technology around a connected home testing system. Through this process, we realized that access to care and diagnostics wasn’t a technological issue––it had to do with labeling. Over-the-counter (OTC) test results couldn’t be used at the point-of-care (POC) to make clinical decisions, and vice versa, creating a challenge around reimbursement. Today, we’re utilizing the endpoints and labels we defined with the FDA to designate tests with a remote POC and, ultimately, get our first six tests integrated with the incumbent telehealth companies.
CS: How does decentralizing diagnostics impact (and hopefully improve) the quality of care that people can receive?
HL: 70% of all medical decisions are based off diagnostics, and if you can’t bring those tests to home-based populations, you’re limiting the efficacy of their care. By bringing diagnostics and virtual care into the home, we can improve patients’ quality of life and help them get the care they need––addressing key barriers like transportation and cost.
CS: How do you ensure that those tests are accurate and producing actionable data?
KM: We don’t make the tests, but we do work with manufacturers whose tests have been clinically validated and approved for either POC or OTC usage. For our part, we add the digital read, an AI-powered interpretation coupled with a high-resolution image of the device, helping us capture the test’s results in a way that’s reliable and without human error. We then send that data back to the ordering provider in a digital format.
CS: I imagine you do a significant amount of collaboration. How do companies work with HealthCheck to get their test into the ecosystem effectively?
KM: We’re starting to work with the test developers earlier, while they’re still developing their tests or taking it through the approval process. Because most OTC tests are cash pay, the most critical part of the process is making sure a test can be reimbursed in conjunction with telehealth.
HL: To solve the issue of reimbursement, we must show CMS and third-party payers that a test done in the home is the same (and as good) as a test done at the POC. That’s one of the biggest factors slowing the adoption of at-home diagnostics, and it’s where remote POC really comes into play.
CS: Alongside reimbursement, what other challenges keep you up at night?
KM: It all comes down to labeling. Right now, there’s nothing prohibiting a provider from looking at your test results over a telehealth session and effectively using that test off-label. It’s perfectly legal, but it means they can’t then file a claim with CMS or commercial payers. Ozempic is a great example: Doctors prescribe it for weight loss, but insurance won’t cover the cost because its label supports diabetes management.
CS: Getting back to the collaborative piece, are you working on any partnerships that particularly excite you?
KM: One partnership we’re really excited about is with a Lyme disease rapid test. Another is with a proteomics-based H5N1 test. We’re really trying to work with developers earlier in the process, and that’s where partners like Drummond become so powerful. By facilitating domestic manufacturing at scale, you give us the tools we need to help these developers get their products to market.
CS: How did the 2020 pandemic impact domestic manufacturing and fuel your work at HealthCheck?
HL: When the pandemic hit, we saw global supply chains suffering in several areas, and it really brought the importance of domestic manufacturing into focus––especially in this new era of virtual health.
Likewise, most of the population didn’t previously think that they could test themselves at home, but COVID-19 broke that myth. It shifted the norm from “Oh, I can’t do this” to “Yes, the average person is capable of performing a self-collection.” At the same time, it introduced us to the concept of proctoring tests over telemedicine.
CS: With respect to the regulatory process, are you looking to get ahead of any hurdles?
KM: When it comes to infectious diseases, regulators and public officials have a clear incentive to prevent community spread by finding potentially pandemic pathogens, containing them, and triaging the infected populations at home. Conversely, things like A1c tests can only be accessed at the POC. For individuals like type I diabetics who require four A1c tests per year, that means taking off work, spending money on gas, and so on. If you’re in a rural area and living paycheck-to-paycheck, that can really take a toll.
CS: Studies show that care access is the leading predictor of good outcomes, yet people tend to ignore their health when getting healthcare becomes hard or burdensome.
KM: There’s a lot of improvement in healthcare outcomes just through convenience. Having to wait for an appointment, travel long distances, take off work––these are all barriers preventing people from getting the care they need. If we can start streamlining access to care and diagnostics, we can encourage people to take a more proactive role in their health.
CS: This is always a loaded question for entrepreneurs, but what’s the scariest part of what you’re trying to do?
KM: There’s a lot that goes into standing up a connected diagnostic ecosystem as part of the national healthcare infrastructure, and a lot of room for things to go wrong. You must work with developers, get the regulatory pathway, receive approval, and secure coverage–– and once you have market access, last-mile distribution becomes a daunting task. I mean, rapid tests are a lot less rapid if you have to dropship them, right?
By the end of 2027, our goal is to get our tests within seven miles of 80% of the population. This is an interesting marketplace with so many players, steps, and logistics involved. The hardest part is getting them to work in concert.
HL: Anytime you’re trying to change a population’s status quo, there’s an element of risk. Not only do you have all those puzzle pieces that Ken mentioned, but you also have to deal with the fact that, psychologically, change is hard. Convincing someone to care about a new process or opportunity can be an uphill battle, but we’re up for the challenge.
CS: I always like to close with my favorite (and most selfish) question: What’s one book that has shaped or reshaped your worldview?
HL: The Dark Tower, by Stephen King.
KM: If you had asked me two years ago, I would’ve said Atlas Shrugged, by Ayn Rand. It touches on objectivism and the act of seeing things for what they truly are––an incredibly important skill for any entrepreneur or inventor of things.
Today, I have to say The Innovation Stack, by Jim McKelvey. When we were spinning out of Safe Health and into something new, this book gave me the strength and insight to keep pushing through.
