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Optimistic coverage of “portable gluten test” lacks some key context

nima-gluten-free-cake.jpg

Portable gluten tester from 6SensorLabs.
6SENSORLABS

Restaurants, office parties, potlucks, meals while traveling — they’re a minefield for people with celiac disease and gluten sensitivity who can suffer from stomach pain and upset, swollen joints, and other debilitating health problems when they ingest even a little bit of gluten.

The maker of a new handheld gluten-detecting device hopes to help make eating outside of a gluten-sensitive individual’s own kitchen safer and easier.

The company, 6SensorLabs, has started taking pre-orders for the device it calls Nima, which can test food for gluten and get rapid results, said co-founder and chief technology officer Scott Sundvor.

Nima is not FDA-approved and it’s not intended for medical use, but the company intends it as a “consumer” tool to use when dining out, Sundvor said.

“One of the things that we wanted to make sure we distinguish is that we don’t see ourselves as a medical device,” Sundvor told CBS News. “So we do not need FDA clearance for the device because we are not using it to diagnose or manage disease. We’re simply providing a product to help people know what’s in their food and guide their habits.”

Gluten-free diners can place a sample of food into a capsule or “test pod” and then insert the capsule into a black, triangular device that basically acts like a mini chemistry test. In about two minutes, Sundvor said Nima can tell if the food sample has 20 parts per million or more of gluten. A smiley face means it’s OK; a frowning face means it doesn’t pass muster.

As a point of reference, the U.S. Food and Drug Administration requires manufacturers who choose to put a “gluten free” label on food packaging to meet the same 20 parts per million of gluten standard.

Gluten is a protein found in wheat, barley, and rye. People with celiac disease experience an immune reaction when they eat gluten that can lead to intestinal damage and impact the health of other organs if it’s not managed well. It can cause stomach pain, a swollen belly, acid reflux, diarrhea, skin problems, and other symptoms.

The National Institute of Diabetes and Digestive and Kidney Diseases estimates that about 1 in 141 Americans has celiac disease, but many people don’t know they have the condition. Gluten-sensitive people experience similar symptoms to those with celiac disease and improve when they eliminate gluten from their diets.

Nima is triangular and relatively dainty, about three and a half inches tall by three inches wide, and a little less than an inch thick. “Small enough to fit into your pocket along with your keys and mobile phone or a small clutch,” said Sundvor.

Nima was first conceived when Sundvor and company co-founder Shireen Yates met about two years ago and realized they both had gluten intolerance and other food issues.

“We met at MIT through mutual friends. She was getting her MBA and I’d gotten my engineering degree from there. We had this shared experience; Shireen has several food allergies and I also have several food intolerances. We both just had these issues where we’d eat out and get sick or feel uncomfortable,” Sundvor said. “Shireen had the idea, ‘Why can’t I just test my food and figure out what’s in it?’ So we started talking about the idea and we researched the market and realized it’s something we could make happen.”

It costs $179 to pre-order a tester plus three one-time-use pods, and $47.95 for a refill pack of 12 pods; prices will increase later this month, according to the company’s website. The company plans to deliver the product by the middle of next year after they’ve tested it more thoroughly, Sundvor.

Marilyn Grunzweig Geller, chief executive officer of the Celiac Disease Foundation, said she is not familiar with the new gluten-sensing device and was unable to comment on it directly.

“Certainly an FDA-approved device that could help people determine if they were accidentally ingesting gluten could go a long way to helping people and would be useful.” However, she adds, “I would never comment on a device that’s not FDA-approved.”

She said she’s anecdotally aware of a number of “treatments” for celiac disease and has heard of gluten sensors, but is skeptical.

As for Nima, Sundvor said, “We’re doing a huge amount of testing and one thing we want to be sure of before we start shipping is that we’re 99.9 percent accurate.”

He said they have received Nima prototypes and he and his girlfriend, who has celiac disease, are already trying it out.

The company also aims to create similar versions that could test for peanut and dairy allergens, among other problematic ingredients. A Nima app is in the works, too, that he says will let users share information about restaurants and log their results.

Rating

3 Star

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Portable gluten test promises to ease dining woes

Our Review Summary

gluten testerThis 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.

 

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story clearly states the cost of the “pre-order” version of Nima and the cost of “test pods.”

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Applicable

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.

Does the story commit disease-mongering?

Satisfactory

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.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

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!

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

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.

Does the story establish the true novelty of the approach?

Not Satisfactory

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.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story uses information from the company, but did do further reporting, including interviews with a company founder and the Celiac Disease Foundation CEO.

 

Total Score: 5 of 9 Satisfactory

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