Urine analysis app uChek is about to launch a six-month, 375-patient trial with Merck for Mothers, a Merck-sponsored initiative to reduce global maternal mortality, according to ClinicalTrials[dot]gov. Researchers will test the feasability of providers using uChek to detect preeclampsia and eclampsia in pregnant women in Bangladesh, with usability of the app for healthcare professionals as a secondary outcome measure.
Pre-eclampsia and eclampsia are dangerous pregnancy complications that manifest as sudden weight gain and high blood pressure during pregnancy and seizures after pregnancy. The study will be conducted at the Hope Hospital for Women, on women who are at least 22 weeks into their pregnancy. Each woman in the study will be given both a traditional urine analysis, with a visually inspected test strip, and an analysis using uChek.
At the end of the study, healthcare workers will be given a questionnaire asking them (1) whether they believe uChek is accurate, (2) whether they find it easier to use than the standard of care, and (3) whether they consider it useful in a low-resource setting. Researchers will do a data analysis on the responses.
uChek, which is made by Thane, India-based Biosense Technologies, has a storied history for a relatively new mobile health app. The app uses the smartphone camera to analyze existing, FDA-cleared urine test strips and return likely results to the user. After gaining public awareness via a TEDMED talk in 2013, Biosense became received a public letter from the FDA, calling them out for marketing their app (which was at that time live in the app store) without clearing it as a class II medical device. Correction: A previous version of this piece had Biosense based in California, rather than in India.
In the aftermath of the letter, Biosense CEO Myshkin Ingawale told MobiHealthNews they might approach the FDA issue the same way crowdfunded consumer medical scanner Scanadu did -- by crowdfunding a new version of the app and naming all early backers as part of an investigative usability study. Alternately, he said, they might simply wait until they secured clearance, which they were expecting in March 2014, to send devices to backers.
Which strategy the company settled on is moot: the crowdfunding campaign, a fixed funding campaign on Indiegogo, raised only $15,700 of its $40,000 goal, leaving the company with no money and no backers to reward. As of now, the app is not available in the App store, uChek does not have FDA clearance as a class II medical device (although it is registered as a class I), and the company has been pretty quiet since the campaign ended last September.
A large sample size study with a big-name pharma company like Merck could be just what uChek needs to get back on the map -- not to mention to finally secure that FDA 510(k) clearance.