The popularity of direct-to-consumer and at-home health tests is coming on fast. It's not just pregnancy tests and COVID nasal swabs anymore: Detailed readings of gut health or hormone levels are clicks away, sold online without a doctor's order. They can cost up to a few hundred dollars out of pocket. But is it sound science or modern-day snake oil?
Recently, The Washington Post reported on the wellness DIY test market. With these tests, the patient usually collects their own sample — usually hair, blood or saliva — for analysis. Some direct-to-consumer test samples are taken by a mobile phlebotomist. For tests that are not a rapid positive/negative, the samples are analyzed in a lab.
The FDA recently updated its rules to regulate the tests more strictly.
From food sensitivity to hormones, pregnancy to COVID, the direct-to-consumer health-testing market is taking off for industry leaders and small start-ups alike.
“People are much more open to — they're not scared of taking some blood at home. They're not scared of taking a survey and then seeing their doctor,” said Dr. Laura Jelliffe, UCSF epidemiologist and CEO of EGG HP.
"The real value that we provide to the consumer is that they can get these tests without having to go to a doctor or visit before getting the test,” said Richard Adams, VP and GM of consumer-initiated testing with Quest Health.
The U.S. at \-home diagnostics industry is expected to grow to $9.5 billion by 2031, according to Futurewise Research.
"I got a result that was lower than one would hope for, for where I was with my age and my overall health, no other known conditions. And so that prompted me to get further clinical support," said Silicon Valley investor Anarghya Vardhana.
Vardhana used at-home testing after her company invested in testing company Modern Fertility.
"That prompted me to get further clinical support. I went to see a couple doctors, went to see a couple different reproductive endocrinologists, and through that and more bloodwork, some ultrasounds, learned that my ovarian reserve was lower than it should have been for my age, and that it might be a good idea to explore some kind of assisted reproductive technology,” she told Scripps News. Vardhana is now pregnant with her third child.
"We can be very paternalistic in medicine,” said Christina Farr, the author/owner of Second Opinion, a health-tech newsletter. She has covered home testing for years.
"And so we also need to give patients that information, tell them what they need to know, and then it's up to them whether or not they want to pursue some of these tests. With that said, it's hard to actually figure out what is something that's safe and isn't going to send a patient down a rabbit hole or isn't going to give them inaccurate results, which can be very harmful. Or the other end of it, which I think is even more concerning, when a patient is given false reassurance," said Farr.
Farr, like every expert we spoke with, told Scripps the industry still has a way to go, and companies need to have clinical guardrails.
“Some of these things can look very legitimate. When you go to the websites, you might see a long list of scientific papers and medical journals. And so you can come to think that these are very legitimate products as a result, but they're just linking to random studies," Farr said.
“They can be held to a different standard and might not necessarily have to go through all of the rigorous testing that we might expect for a pacemaker that we're putting inside of our heart," said Northwestern Memorial Hospital reproductive endocrinologist Dr. Jessica Walter. "And so it's important to keep that in mind as consumers."
Walter says she's seeing more patients armed with data at their first appointment.
“Either from a test that they ordered off the internet and did at home, or because they've been tracking their cycles with a wearable device. The difference [between at-home and in-clinic testing] is really, I think, is counseling. Both pre- and post-, in that you're going to know what tests we're getting, why we're getting them, what they're going to tell us,” said Dr. Walter.
More warnings exist for do-it-yourself food-sensitivity tests. The two board certified allergists we spoke with would not recommend them.
"It's not accurate. So food sensitivities — a lot of these tests measure something called IgG against certain foods. And all that tells you is that you've been exposed to the food,” said Dr. Purvi Parikh, an immunologist and allergist.
"And some people will go down a rabbit hole avoiding a lot of foods, potentially unnecessarily,” said Dr. Zachary Rubin, also an immunologist and allergist. “And that can create a lot of anxiety that could potentially create some nutritional problems.”
Ultimately, it's the savvy customer's job to decipher the science and lean on clinicians as the trend in home testing continues to fill a growing need.
“You and I both know, and all the viewers watching know, that it's really hard to get a medical appointment. And patients and families want and deserve faster care, faster answers, and a faster path to knowing what's happening with themselves,” Vardhana said.
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