
Power to the Patient
Medicine is coming to your living room. In fact, you could argue that it’s already there. The first at-home pregnancy kit hit the U.S. market in 1976 (then it was called E.P.T. — first for “early pregnancy test” then for “error-proof test,” which, of course, it was not). Since then, it’s gone through a number of iterations — color-changing test strips, plus or minus signs — leading up to the tests on the market today, many of which have digital readouts that simply say either “pregnant” or “not pregnant.” Now, the technology is so cheap and ubiquitous that furniture company Ikea used it in a recent advertisement, offering crib discounts to pregnant women whose hormone-laden urine revealed a special discount code. The vision of the at-home pregnancy test was a noble one: A woman could walk into her local pharmacy and purchase some medical-grade clarity about her reproductive future, without the immediate need to discuss sensitive or taboo subjects with doctors. Today, at-home assessments can test for much more than pregnancy. You can pick up tests for urinary tract infections, assess fertility by way of ovarian egg reserve, and check for sexually transmitted diseases at your local pharmacy. Even genetic testing kits like 23andMe are now available at retailers like Walmart. The internet holds other types of kits to help consumers discover everything from their ancestry to their complete microbiome. These tests are part of a larger healthcare trend toward improving patient access to medical services while reducing their cost. The market for DIY medical tests is rapidly growing: It’s projected to reach $340 million by 2022 as existing tests become more affordable and scientists develop completely new tests. On an economic level, direct-to-consumer (DTC) medical tests could help low income or rural families access affordable medical care, no matter whether they’re insured, and reduce healthcare costs overall. Already, when a consumer considers taking a DIY test, the question is often not can they test for a specific condition, health trait, or genetic predisposition — but should they? For now, the answer may be fairly straightforward. But as the tests evolve to encompass a broader scope of conditions, that may no longer be the case.DI-Why?
There’s not just one reason why patient-consumers are drawn to at-home medical tests. Health problems — either for the individual or for someone in the immediate family — may prompt people to want to learn more about what’s going on in their bodies. But the affordability, accessibility, and usability of at-home medical tests have allowed many people to partake purely out of curiosity. For many consumers, at-home medical tests are appealing not just because they’re convenient and discreet compared to traditional medical care, but they can be more affordable. Let’s take, for example, a person with a sore throat and a fever. This person has no health insurance or primary care doctor. They also don’t live close to community health or urgent care clinics, where patients can often be seen more quickly (and for less money) than a primary care doctor. While it may seem unfathomable to people living in urban areas, it’s not unusual in more rural parts of the U.S. for people to travel great distances to access healthcare. As a result, it’s not uncommon for patients to resort to going to the emergency room to get a strep test, particularly if they are also uninsured. Our example patient with a sore throat may do this, and if the test is positive, the ER doctor would be able to write them a prescription for antibiotics. The cost of that visit without insurance doesn’t just factor in the test and the medication — the patient is also then paying the fee for the physician and the hospital. Depending on where the patient lives, the cost for the entire visit could rack up bills totaling in the hundreds or thousands. But a rapid strep test kit purchased at her local CVS (or even on on Amazon) only costs around $35. If the test is positive, the patient’s doctor may be willing to call in a prescription for the antibiotics needed to treat it, which typically cost around $5 at most major retail pharmacies. At-home medical tests that are used to diagnose a condition like strep could cost even less for patients who do have insurance; while patients would still have to pay up front, as Consumer Reports noted in 2015, several major insurance companies reimburse the cost of the test if it’s ordered by a patient’s doctor and deemed to be medically necessary.
The Doctor Is At Home
Yes, DTC medical tests can be interesting. Sometimes they’re even useful. But most healthcare professionals and scientists know that the tests available over-the-counter are not quite the same (often less precise) as the ones a physician might order. Patients are often less comfortable collecting some of the biological samples that doctors might require, like blood (with the exception of diabetes patients who monitor their glucose levels at home, most patients are not yet taking their own blood samples), vaginal secretions, or a stool sample, though some tests do require users to submit those. The simplest at-home tests detect a single biomarker in the body: it’s either there or it’s not. That’s how pregnancy tests work — a urine sample is tested for the assay human chorionic gonadotropin (hCG), a hormone the body begins to produce once an embryo has attached to the uterine wall. If someone participated in a risky activity with someone who might be HIV-positive, a blood test can determine if they, too, are infected with the virus. Having that information can help patients figure out the next step in treatment or medical care.
Getting to “Joe Schmoe”
Every test comes with some risk — the risk that patients could misinterpret their results and make health decisions based on them that are unnecessary, costly, or even dangerous; the risk that the tests themselves may produce incorrect results. In the latter case, a patient may respond to a false positive or fail to take action in the face of a false negative. To limit those risks, DTC medical tests need both regulators and research to reach patients. Because the FDA considers at-home tests to be devices, the time from lab bench to a patient’s hands is much shorter than it would be for a drug. “Devices are not like drugs…device development is a lot faster,” Courtney H. Lias, the director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, responsible for regulating both in-home and lab-based diagnostic tests, explained to Futurism. For the FDA to approve a DTC test, a consumer needs to be able to get an accurate result, interpret the test in the way it’s supposed to be interpreted, and ultimately have the test’s benefits outweigh its risks, Lias said. Throughout the FDA’s approval process, the agency is looking for data and supportive evidence of not only the test’s efficacy, but also its usability. “If ‘Joe Schmoe’ goes into the drugstore and buys this, how will it work in his hands?” Lias said. End-user testing for new kits is key; if the kit is going to be marketed to average people, then the company hoping to get the kit approved needs to demonstrate that prospective users can actually use it as intended.If ‘Joe Schmoe’ goes into the drugstore and buys this, how will it work in his hands?

The Future of At-Home Medicine
As technology progresses, new tests, along with other forms of DTC medical care, will fill in gaps in the existing medical system. Not only can doctors video chat with one another to review case notes, but patients can engage with their physicians — even having consults or exams — via Skype and with the help of wearables that can transmit their vitals directly into a portal for their doctor to review. As the technology that makes such remote encounters possible becomes more refined, doctors may one day be able to make “digital house calls” when patients are ill or injured. That would improve the efficiency and affordability of medical care, providing a boon to public health: If a physician can remotely determine if a patient has an infectious disease, the patient wouldn’t have to come to a public medical facility and risk infecting others. Ultimately, it could reduce the spread of those kinds of illnesses.