Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urine analysis system, has already had a busy year.
Its cofounder appeared onstage at TED. Its uChek system was held up as an example of FDA's lack of enforcement in a Congressional hearing in March. The FDA subsequently took the rare action of sending the company a warning letter about uChek that instructed them to either seek a 510(k) clearance or explain why it didn't need one.
Biosense's uChek Lite application, which is registered as a Class I device, is a free app for iPhone users that can interpret color changes on urine analysis test strips (sold separately, of course) by leveraging the smartphone's camera. While users need to buy the test strips from third parties the uChek Lite system also required a kit from the company which included a mat that helped the app better read the colors and a cardboard box that was placed over the test strip and color coded mat and which the phone nestled into and took a photo through. (This diagram from the company over at 9to5Mac illustrates the process nicely.) The uChek Lite kit costs about $25.
Biosense is now working to commercialize a next generation uChek system, called uChek Universal, that replaces the cardboard box with a more rugged one made of medical grade ABS plastic. The new device would involve fewer steps for users, would auto-center the phone's camera, and do away with the need for a separate color coded mat. More importantly, uChek Universal aims to provide early warnings, advice, and recommendations following a user's test. The next generation uChek would also test 14 parameters (compared to the 8 with uChek Lite), including: glucose, protein, urobilinogen, calcium, blood, creatinine, pH, ketone, bilirubin, specific gravity, nitrites, leucocyte, ascorbic acid, microalbumin. Biosense expects to sell the uChek Universal kit for about $80.
When I asked Biosense cofounder Myshkin Ingawale for some examples of medical issues that the uChek Universal would be able to detect and give early warnings for. Ingawale was quick to respond that the device would detect "possible causes of abnormalities" and that "the user could then have investigated in further detail by a trip to the doctor" and that uChek is "by no means [providing] a definite diagnosis" or "a replacement for the doctor". The list he sent, however, included more than 60 medical conditions, diseases, or issues like diabetes, pregnancy, starvation, kidney stones, and alcoholism.
Ingawale and the team at Biosense are taking a page from Scanadu's crowdfunding playbook -- the medical tricorder company that just broke Indiegogo's record to become the most funded campaign in the site's history -- and plan to crowdfund the uChek Universal device to raise money pre-FDA 510(k) clearance. While Scanadu crowdfunded its SCOUT device and is providing supporters with the devices pre-FDA by designating them as early testers of the device who can help it collect data that will help it secure a 510(k) Class II clearance, Ingawale says Biosense's plans are still a bit up in the air.
Right now two paths are likely for the crowdfunding campaign, which is set to launch in a few days: uChek Universal will either ship to its supporters as soon as it receives FDA Class II clearance (hopefully by March 2014) or Biosense will leverage Scanadu's strategy and send the devices out pre-FDA clearance to its supporters who will act as testers of the product. Ingawale says he is still discussing those plans with FDA officials.
In any case, Biosense's plans to push ahead show that it survived the verbal lashing from the FDA -- at least in spirit -- and, assuming the crowdfunding campaign goes well, is forging ahead with yet another smartphone-enabled urine analysis device.
