Silicon Valley home diagnostics company Scanadu, best known for its Indiegogo smash hit and Tricorder X-Prize competitor the Scanadu Scout, is coming back into the spotlight after a few years, now with a new name: inui Health. The company announced today that it has received FDA clearance for its smartphone-enabled home urine testing platform that can conduct five common tests, with more to come.

“Urinalysis has traditionally has been something done in a lab, frankly in an archaic way,” Inui Health CEO Jamie Tenodorio told MobiHealthNews. “The basic technology that’s being used today was invented in the mid-1950s. It’s evolved somewhat since then, but basically you’re dipping and switching and holding stuff up to the color chart. We are in the new millennium and there’s better ways to do that, we thought. So that’s one problem we set out to solve. The other problem is giving patients immediate and timely access to their own data.”

The product is not the first smartphone-connected home urine testing product cleared by the FDA — in fact its one of at least three, along with Healthy.io and Scanwell, that’s come through in the last two years. But Tenodorio says it’s more advanced than the competition in several key ways. For one, they offer more tests than most.

“We have protein, glucose, leukocyte and nitrite, and ketone already on the platform,” Tenodorio said. “Leukocyte and nitrate are geared toward assessing UTIs. Urine glucose is a measure of a potential indicator for diabetes or pre-gestational diabetes. Ketone is a metabolic indicator and protein can be used for a number of indications — kidney function, other kidney issues and is also one of the diagnostic indicators for pre-eclampsia.”

Additionally the company prides itself on its AI and data architecture that allows users to instantly access their own test results —compared competitors that require results to go through a provider before patients can see them.

“We developed some very sophisticated data capabilities that were leveraged into this product,” Tenodorio said. “Our data back-end is not just a data repository. We have a HIPAA compliant data structure that wraps data to medical systems. We’ve used that to take data in 51 countries over the last few years. We completed a clinical study in sub-Saharan Africa a few months ago in villages and small cities, and we were seeing encrypted, secure data come into our system in realtime.”

Finally, inui will support more than a dozen different phones out of the box.

“There is also this aspect of bringing a diagnostic lab on an inexpensive phone anywhere in the world,” Tenodorio said. “Whether it’s a home, a small remote clinic, a village in sub-Saharan Africa, or a midwife visiting an underserved rural area, we bring that diagnostic to point of use which allows early intervention and early identification of people that could be at risk for conditions or diseases.”

The system will be available from inui's website as a pack of three tests for $34.99, and the clinical version of the product is also available to enterprise customers who contact inui.

Leaving the Scout in the past

Inui’s urine analysis project has been part of the company’s mission since the beginning — the company announced plans for a urinalysis product, at the time called ScanaFlo, back in 2012, along with a flu-testing product called ScanaFlu.

But it was the company’s Scout device, a multifunction home health scanning device, that made the company famous after a blockbuster $1.6 million Indiegogo campaign, a record for the platform at the time.

That campaign would become mired in controversy. In addition to significant delays, the company was made available to customers ahead of FDA clearance through an unorthodox arrangement. All project backers who backed at the level to receive a device were enrolled in a clinical trial so they could receive the unit as an investigative device.

When the study concluded, the devices, which were only provided to backers at the $149 level and above, ceased to function. To what extent customers were aware of that outcome is a point of contention, but it certainly angered some number of customers, a few of whom dubbed the whole arrangement “Scamadu”.

Tenodorio — who took over the company from founder Walter DeBrouwer in 2016, long after the Indiegogo campaign and near the conclusion of the trial, maintains that what happened with the Scout was on the level — and that the company narrowed its focus solely because of the overwhelming potential of the urinalysis product.

“Scout was an investigational device. I will say that one more time, it was investigational,” he said. “Everyone that received one signed an informed consent form to participate or they couldn’t participate. It was a first of its kind trial. Over 4,000 people participated in terms of taking data. UC San Diego Scripps was the leader of that. We got tremendous benefit from that. We made the decision to focus first and for the foreseeable future on the diagnostic area because we had not only enormous IP, but we could bring this to reality on a phone and put it in the hands of patients around the world, and that was too exciting to ignore.”

Tenodorio didn’t respond definitively to the question of whether the company would ever revisit Scout, but said the company is exploring many ways to use its deep bench of intellectual property and that the backend architecture of inui was informed by learnings from the device.

As for the new name, it was a matter of forging an identity that matched the company’s new direction.

“I don’t know that I’d call it a rebrand,” he said. “We stepped back and decided what our brand identity needed to be, having a diagnostic lab anywhere and any time. We’re not scanning anything with this product. We wanted a brand that fit that mission and we wanted a brand vessel that we could fill and create an identity around. So we worked with a very well-known naming and branding agency to help us arrive at that name. It has an association with intuition and knowing yourself, and beyond that it’s our brand vessel to carry our brand identity.”