Urine-analysis app turns to Indiegogo to help it win FDA clearance

Another health device company is turning to the crowd for feedback as much as for funding. On Tuesday, Biosense Technologies is planning to launch an Indiegogo campaign for a new iPhone app (s AAPL) and portable “lab” that analyzes a person’s urine for health problems – but the company isn’t just hoping to raise some cash, it wants to recruit users who can contribute data that could help it get clearance from the Food & Drug Administration.
The move comes on the heels of Scanadu’s record-breaking, million-dollar campaign for its medical “tricorder” device that similarly invited users into the clinical trial process. And Biosense isn’t shy about acknowledging that it’s following in the path of its peer.
“We want to involve the users from the get-go to get the full data, which would really help us through the [FDA] approval process,” said Myshkin Ingawale, the company’s co-founder.
Back in February, Biosense drew headlines when it launched its uChek Lite iPhone application at the TED conference. With the app and an accompanying cardboard testing kit, the company said it can help users identify conditions like diabetes and urinary tract infections, as well as track general health – all by analyzing their urine for range of proteins and elements.

Monitoring health from home

But while its first app provided users with data, Ingawale said its new Indiegogo-bound app “provides the meaning behind the data.” For example, its new app, uCheck Universal, tests 14 parameters, compared to just eight tested by uChek Lite. Ingawale said it’s also easier to use and provides more information on early warnings and recommendations.  It’s also more expensive: While its first product was $25 per kit, the new option will clock in at $80 a piece.
uchek screenTo start, users are instructed to dip test strips into a urine sample and then place their phone on top of a plastic mobile “lab” (a more durable upgrade from the cardbox box). The testing strips fit beneath the phone on a special mat intended to normalize lighting conditions. Once users take a picture of the testing strip, the app generates a report of its results.  For example, if it detects a certain ratio between creatinine and microalbumin it would alert the user that they might have a kidney problem, Ingawale said.
One potential drawback of a non-clinical test is that contamination could lead to inaccurate results. But Ingawale said Biosense not only gives users explicit directions for collecting the best sample, one of the elements it tests for can help gauge contamination.
For consumers, he emphasized, the kit isn’t meant to replace a visit to the doctor, but give people more information about their health and let them know when they need to follow-up with proper medical attention. But, he added, that in some place, like rural India, uChek Universal could be used by mobile clinics to provide diagnoses and care.

A new approach to clinical trials

Unlike the first kit, Biosense said that uCheck Universal will need Class II clearance from the FDA – and that’s where its users fit it. Ingawale said the company hopes early users of the new device will be able to provide data that will help with the approval process. (Its first device was not as full-featured but still attracted attention from the FDA after it launched. Ingawale said uCheck Lite, which is a Class I device, shouldn’t need special clearance, but that the company is in talks with the FDA and will follow their guidance.) As my colleague Stacey Higginbotham pointed out, more companies are trying to use remote patient monitoring and home data collection to speed up the clinical trial process.
Interestingly, Biosense isn’t the first startup to launch an Indiegogo campaign for a device that uses urine analysis to detect health problems.  Earlier this month, New York startup Pixie Scientific generated a ton of buzz with claims that its “smart diaper” and iPhone app could detect when a baby might be suffering from a urinary tract infection, dehydration or other problems.