Several firms are trying to bring the clinical laboratory to patients’ doorsteps, but the task comes with plenty of challenges.
In the scheme of things, the remote diagnostics start-up Ixlayer has very little in common with the infamous “one drop” blood-testing company Theranos. The former helps facilitate remote medical testing by working with healthcare providers and clinical laboratories, whereas the latter falsely claimed to be able to perform a host of medical tests based solely on a finger prick’s worth of blood (the company’s founder, Elizabeth Holmes, was convicted of fraud earlier this year). Yet, despite the very different promises and approaches of the two companies, Ixlayer’s executives frequently get asked the “Theranos question” when meeting with potential clients “all the time,” says Alecia Pritchett, the San Francisco company’s chief growth officer.
The Theranos question is really just a way of asking whether the company can be trusted. Remote medical testing sounds great, but the Theranos case looms as a cautionary example of the risk associated with outsourcing such an important task. The thing is, although Theranos’ claims might have falsified its scientific capabilities, the company was indeed ahead of its time in seeing the potential of convenient, easily accessible medical testing. Thus, when the “T word” inevitably comes up, Pritchett takes the opportunity to explain that her company has replaced Theranos’ sketchy promises with real-world scientific and logistical advances. The Theranos case “absolutely still impacts our work today,” Pritchett says. “but in a good way.”
In the years since Theranos folded, other market entrants have made significant strides to create a world where getting diagnostic and genetic information does not necessarily require a trip to a clinic. All of which has set up a moment in which the future of the industry is being decided in real-time, helped along by a global pandemic and the urgent need for at-home testing that accompanied the public health crisis.
Although the medical testing industry is in a phase of great innovation, Pritchett says the industry’s technical advances have not always translated into enhanced patient access.
“All these labs spent a lot of money, time and (research and development) effort to create amazing tests,” she says. “And, really, the only way patients have to access some of these tests is through their physician. You have to hope that clinician happens to know these tests are available.”
Ixlayer was founded in 2017, well before the start of the COVID-19 pandemic in 2020. However, the pandemic was an inflection point for at-home testing, Pritchett says. “The pandemic really accelerated things.”
Before COVID-19, many healthcare leaders and executives viewed at-home testing as futuristic at best. Those with an early adopter mindset focused testing for stigmatized conditions such as sexually transmitted infections. The logic was that more individuals would get tested because at-home testing afforded some privacy.
The COVID-19 pandemic resulted in health systems, providers and patients using telehealth much more than anyone imagined. Moreover, tens of millions of Americans have tested themselves for COVID-19 infection. As a result, the home test kit is now a familiar part of American self-care. However, the pivot into telemedicine and home testing has also exposed some shortcomings. “There’s this big gap where there’s only so many things you can do via telehealth,” Pritchett says. “There’s not a lot of infrastructure around how you get diagnostics into folks’ hands.”
Ixlayer bills itself as the company that can fill that gap. The “I” stands for infrastructure and the “x” is for patient experience. The company is not a lab; it describes itself as a platform. Instead of performing its own lab tests, Ixlayer says it connects providers and retailers to accredited laboratory partners. Instead of sending out its own team of phlebotomists to collect blood samples, the company coordinates with mobile phlebotomy firms.
In late October, the company announced a new partnership with CVS Health to provide CVS-branded at-home sample collection kits to test for vitamin D, Lyme disease, sexually transmitted infections and thyroid function. The deal also includes patient education functions to help patients interpret their results. The firm raised $75 million in a Series A funding round last year that was led by General Catalyst, a leading healthcare venture capital firm.
Ixlayer has some well-known individuals on its advisory board, including David Shulkin, M.D., former secretary of the Department of Veterans Affairs, and Moncef Slaoui, Ph.D., M.B.A., who led Operation Warp Speed, the federal government effort to develop COVID-19 vaccines during the Trump administration. Later, Slaoui was fired from a post at GSK because of a sexual harassment claim.
Questions and concerns
Many providers are still wary of remote testing. Putting testing in the hands of patients does have some risks. Testing is costly, and a misdiagnosis can make it even more so. There’s a reason most testing is done in a clinic by trained professionals. “There’s a lot of scrutiny on the industry for these at-home tests, as there should be,” Pritchett says.
That is one reason the company has chosen the infrastructure route rather than providing an end-to-end solution, she said. Its solutions are based on the needs and clinical standards of their clients, making the company more of a facilitator of testing than a marketer of tests.
“Typically, when we work with large groups, they tell us how they want us to handle certain situations (and) what clinical protocol to follow,” she says. “That’s a big important differentiator between the types of services we’re looking to provide and maybe a third party who’s just doing direct-to-consumer kits.”
Market differentiation is a key focus for Ixlayer and companies like it because the industry is rapidly growing. Several remote testing start-ups have already launched, including Everlywell and LetsGetChecked, and big-name retailers and tech firms have expressed interest in launching medical diagnostics products and services.
Meanwhile, many U.S. consumers, after self-testing for COVID-19, have grown accustomed to the do-it-yourself medical test and appear ready and willing to embrace the concept.
A recent survey from the University of Michigan Institute for Healthcare Policy and Innovation found 48% of adults aged 50 to 80 years had already bought an at-home test, and 82% said they were “somewhat” or “very” likely to take an at-home test in the future.
Even so, Ixlayer is to working with healthcare industry partners rather than marketing their tests directly to consumers.
“We’re thinking of it more from (the perspective of): How do we infiltrate this infrastructure into our whole healthcare ecosystem?” Pritchett says. “How do we let traditional providers run their programs the way they want to?”
That approach has the added benefit of letting Ixlayer avoid having to seek reimbursement from payers. Although payers are increasingly willing to cover at-home testing, reimbursement for such tests is not universal, and some tests have significant costs that would be difficult for some patients to afford on their own. Because Ixlayer’s clients are healthcare providers, retailers and large employers, the reimbursement question falls to other stakeholders.
Yet, Pritchett notes, the company isn’t steering entirely clear of the costs to consumers and payers. Ixlayer is looking into technology that would help patients better understand whether their tests will be covered by their insurance and the out-of-pocket costs that they might have. “That’s something we’re going to spend a lot more time on over the next 12 to 24 months,” she says.