A ‘Shark Tank’-funded test for food sensitivity is medically dubious, experts say

When Julia Cheek walked onto the set of “Shark Tank,” her five potential investors wore their trademark scowls. Yet within minutes, their demeanor changed, eyebrows raised and heads nodding as they peppered her with questions about her company, EverlyWell, and its promise to revolutionize medical diagnostics.

“EverlyWell is transforming lab testing — a $25 billion market — to be simple, convenient, and useful for you,” she told the judges with a smile. Beside her sat a display of the company’s wares: mail-order test kits for everything from testosterone levels to sexually transmitted infections.

When Cheek left the stage, she had a fresh $1 million commitment from investor Lori Greiner. And the company is wowing more than just the television judges. EverlyWell garnered $6 million in sales last year, a spokeswoman said, and Cheek told the judges that this year they expected that to double.

But what EverlyWell describes as one of its best-sellers — a test for food sensitivity — is of dubious medical value, according to experts interviewed by STAT. The $199 test promises to use a fingerprick’s worth of blood to gauge whether a person’s immune system is active against 96 common foods, including asparagus, garlic, and eggs. An immune protein called immunoglobulin G, the company’s website says, could be to blame for symptoms such headaches, stomach pain, diarrhea, and fatigue.

Other online vendors sell immunoglobulin G tests for food sensitivity as well, though none have reached EverlyWell’s degree of prominence. All are considered laboratory-developed tests, and are therefore not regulated by the Food and Drug Administration.

Yet physician groups have for years advised against using immunoglobulin G tests to evaluate for so-called food sensitivities or intolerances. And allergy experts told STAT that the test is useless at best and could even cause harm if it leads customers to unnecessarily cut nutritious foods from their diet.

“EverlyWell believes providing this test aligns with relevant third-party research around the [immunoglobulin G] test’s usefulness in conjunction with an elimination diet,” the company said in a statement.

To test or not to test

Food sensitivity is an umbrella term that encompasses symptoms that can arise, for example, from difficulty digesting a food, as in lactose intolerance, or susceptibility to the effect of a food, as in caffeine sensitivity. These symptoms, however, do not involve an immune response. (Food allergies, on the other hand, have more serious symptoms and are driven by the immune system; validated tests for them do exist.)

Patients who ask Dr. Robert Wood, an allergist at Johns Hopkins Children’s Center, whether they have a food sensitivity would never undergo an immunoglobulin G test. Immunoglobulin G tests “are completely useless and do dramatic harm” because they may compel patients to unnecessarily avoid broad swaths of a healthy diet, Wood said.

“In all my years of practice, I have never sent an immunoglobulin G test because they have no ability to predict food sensitivity,” he said.

That’s because immunoglobulin G stems from the body’s normal immune response to exposure to many substances, including food. High levels don’t indicate a problem; they simply point to foods a person recently has eaten.

For these reasons, a 2008 European Academy of Allergy and Clinical Immunology task force recommended against testing for a type of immunoglobulin G to evaluate for food intolerance. In the report, the group wrote that the test was “irrelevant for the laboratory work-up of food allergy or intolerance and should not be performed in case of food-related complaints.”

In 2010, a subgroup of the American Academy of Allergy, Asthma & Immunology, or AAAAI, endorsed this recommendation. And two years later, the Canadian Society of Allergy and Clinical Immunology too released a position statement discouraging the use of the test. The group noted that “positive test results … are to be expected in normal, healthy adults and children,” and that the test “increases the likelihood of false diagnoses … unnecessary dietary restrictions and decreased quality of life.”

A spokesperson for EverlyWell stated the company believes “there is a divergence of views regarding IgG tests,” and that the AAAAI does not speak for all health care providers. The company pointed to a handful of small studies that have showed immunoglobulin G helped guide elimination diets — that is, trials of cutting certain foods out of the diet and gauging symptom improvement.

“IgG tests are currently ordered by thousands of medical providers in the U.S.” the spokesperson said.

Dr. Martha Hartz, an allergist at Mayo Clinic in Rochester, Minn., says she frequently evaluates patients who’ve already forked over the cash for the testing. “Anytime I see a patient who’s had these kinds of tests, we get them to toss it aside,” Hartz said. “It has no relevance to anything. It is just not a test that should done.”

Booming industry, shaky science

EverlyWell’s test is just one entry to the booming field of at-home testing. Alongside players in the genetic space, such as 23andMe and Color Genomics, upstarts are taking aim at standard medical testing.

EverlyWell and competitors such as Thorne allow customers to take a small blood sample at home to run a variety of tests. Others offer a narrower range of products: Habit, for instance, focuses on nutrition; Blueprint for Athletes caters to fitness enthusiasts.

But in the sheer scope of its vision the most obvious analogue to EverlyWell is blood-testing startup Theranos, which also aimed to upend the laboratory testing industry. At one point the company soared to a $9 billion valuation on its direct-to-consumer lab tests. But investigations revealed that its proprietary blood testing technology was deeply flawed, leading to a number of lawsuits; the company now is reportedly pivoting to medical devices.

No shortcut

EverlyWell’s food sensitivity tests exploit a frustrating fact for those wondering whether their symptoms stem from the food they eat: There is no easy way to find an answer. The doctor-advised approach is to cut common offenders from the diet one by one — a so-called elimination diet — but that is cumbersome, time-consuming, and, by its very nature, restrictive.

“It is hard to remove certain foods from the American diet, and people may want a definitive way to know which foods cause symptoms without eliminating it,” said Dr. Christina Ciaccio, an allergist at the University of Chicago. “Unfortunately, such a test doesn’t exist.”

In addition, cutting out entire food groups carries risks such as malnutrition, particularly in children. (EverlyWell does not offer tests to anyone below the age of 18.)

And, though rare, symptoms such as bloating or headaches can be a sign of something more sinister, such as cancer. That’s why an elimination diet is best conducted under physician supervision.

When a person sees the doctor to learn about possible food intolerances, they’ll likely be irked to find that the cash they spent on food sensitivity testing ordered online or at an “alternative” practitioner’s office was money down the drain.

“Most patients in the end, when we have done our workup and come up with a plan,” Hartz said, “are actually quite frustrated that they spent all this money on a useless test.”

This story has been corrected to reflect the types of at-home blood tests offered by competitors.