This feature story describes a start-up company’s plans to soon begin marketing a pocket-sized device said to quickly detect gluten in any food with “99.9 per cent” accuracy. To its credit, the article makes clear that the device, called Nima, is neither FDA-approved, nor meant to diagnose or manage celiac disease or “gluten intolerance.” And it goes to some lengths to put gluten-related health problems in perspective and avoid disease mongering, making clear that Nima’s gluten test is designed only to help those dining out test restaurant and party foods for a protein with the potential to make them sick. However, the story offers no quantitative or other evidence for the accuracy of the device; doesn’t discuss harms; and it could have done a better job of noting that the “gluten free” food craze has lured huge numbers of customers with no documented history of celiac disease to buy expensive (and often taste-free) products. The story surprisingly did not mention that the device’s developers had a National Institutes of Health “Innovation” grant (SBIR), and it could also have been strengthened by noting there is at least one other company that claims to also have quick “gluten tests” for sale to consumers, and at a far lower price than the $179 introductory price for Nima mentioned in the piece. A reader (and certainly these reviewers) might also well consider the story premature, given that the company is taking only “pre-orders” for a product it says won’t be available until mid-2016, and that is still being tested.
As the story points out, people with celiac disease, an immune system disorder, experience miserable GI and other medical symptoms, and possible intestinal damage, when they ingest even small amounts of gluten protein, which is abundant in products made with wheat, barley and rye. For them, eating anything they didn’t carefully prepare themselves at home poses a risk, and having a two-minute test might indeed help them avoid some kinds of gluten exposure. Products that provide more freedom to consumers with dietary restrictions are potentially quite useful, and it is very likely there will be more such products to follow (the story mentions development plans). Individuals with celiac disease could avoid much, if not all, of the problem, by eating only unbreaded fish, meat, and chicken; ordering unsauced green veggies; and avoiding pastas, breads, croutons or any salad dressing other than oil and vinegar they mix at the table. But that’s a tough diet, and it’s difficult to avoid cross-contamination of gluten products in restaurants. Even gluten-free menu choices (and supermarket products) may not be as gluten-free as advertised.
The story clearly states the cost of the “pre-order” version of Nima and the cost of “test pods.”
The story references a company official who says that Nima can tell if the food sample has 20 parts per million or more of gluten. But the story never provides any data tor numbers to back this up. The inventors claim that they are doing “a huge amount of testing,” to “be sure” of “99.9%” accuracy, but there are no test data given in the story.
One could argue that since the company owns up to the fact that it has carefully elected not to seek FDA approval, it has no requirement to offer hard data about the product’s accuracy or benefits for peer review or to the public. But we hold news stories to a higher standard. Clearly the company has done some testing — what have those tests found? The story had an obligation to push for and analyze those numbers, or make it more clear to readers that we have no idea how accurate this test might be.
Without any evidence one way or the other about the “mini chemistry test’s” accuracy, it’s hard to know if there might be any false positive or negative readings, and thus any harms from eating food that has more gluten than the test user thinks. The story doesn’t discuss this.
Except for the testimonials of the inventors, there are no data. But the story is pretty transparent about the fact that the company has elected not to seek FDA approval, which suggests that there are no publicly available data on the device. Our feeling is that this criterion shouldn’t count for or against the story, so we’ll rate it Not Applicable.
The story offers federal prevalence data for celiac disease, although as noted above, it could have made clearer that a lot of people who think they are gluten-intolerant likely are not. The problem of misperception about dietary intolerance is real, and results in restrictive diets for no reason.
Importantly, the article quotes the CEO of the Celiac Disease Foundation as skeptical about the value of gluten sensors in general, along with purported “treatments” for the disorders. And she makes clear that she “would never comment on a device that’s not FDA-approved.” Bravo!
The article would be stronger if it mentioned not only the availability of other tests on the market, but also ways that those with celiac disease can reduce their risk of harm when they travel, eat out, or go to parties. There is increasing availability of restaurants with the “GF” notation on the menu, indicating gluten free choices.
The availability of the product is a bit vague, but it’s there. The timeline of “the middle of next year” is provided for availability.
This is not the only product under the sun designed to quick-test for gluten, although to be fair, it’s unclear whether another product would be better/worse/as good. A quick online search identified a number of consumer kits available. It is unclear why a story focusing specifically on this particular device is news.
The story uses information from the company, but did do further reporting, including interviews with a company founder and the Celiac Disease Foundation CEO.
Systematic, Criteria-Driven
FINALLY..... a commonsense analysis of yet more HYPE in the media about the next great hope for eliminating breast cancer. Thanks @mcjaklevic and @HealthNewsRevu. https://twitter.com/garyschwitzer/status/1192417365843206145
Here we go again: another “simple blood test" for early detection of breast cancer. News reports shout “CANCER BREAKTHROUGH” & other hype for preliminary, very limited findings. https://www.healthnewsreview.org/2019/11/theranos-redux-not-really-but-claim-of-a-simple-test-for-breast-cancer-warrants-scrutiny/
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