inui Health, a Silicon Valley digital health company, has announced the launch of its flagship diagnostics in-home urine analysis platform. The diagnostic platform, which includes a disposable test and smartphone app (iOS and Android), has received 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA), plus a CE Mark certification. The tests have been used in multiple clinical studies in the United States and Africa and were also validated in Europe and the Middle East, where inui has brought modern lab testing directly to patients in remote villages far from the nearest hospital.
 
inui Health delivers a cost-effective, clinically accurate healthcare diagnostics test in a less expensive, far more convenient manner than traditional urine analysis methods. To immediately view the results of inui’s diagnostic test, users simply dip and use the phone guided app to conduct the test. The inui diagnostic system measures protein, glucose, leukocytes, nitrites and ketones in urine and it can be used to monitor general health, kidney function, metabolic disorders (e.g. diabetes mellitus) and screen for urinary tract infections (UTI).
 
“We see an unprecedented opportunity in bringing powerful diagnostic tests currently only available at labs or clinics to the hands of consumers,” said Jaime Tenedorio, CEO of inui Health. “We are enabling individuals to perform these tests anywhere in the world, from Manhattan to sub-Saharan Africa, empowering individuals to know more and worry less about their health. At inui, we are excited to bring the diagnostic lab to areas with no laboratories or limited medical facilities.”
 
inui Health allows users to:

• Be empowered to take their healthcare into their own hands.
• Conduct clinical-grade urine analysis testing anywhere in the world; these tests were previously available only at a lab or a clinical setting.
• Receive personalized health data when it matters most—inui works across 12 mobile platforms and test results are interpreted and displayed within one minute.
• Share their results via a HIPPA compliant system with healthcare providers remotely and stage timely interventions.
• Be confident in the quality of the results, which have been validated through rigorous trials during the FDA and CE Mark approval processes.

 
inui Health’s vision is to bring diagnostic capabilities to consumers’ hands in order to provide them with medical-grade information. Urine testing is a non-invasive, medically rich diagnostic test that can yield powerful information about someone’s health. The clearance of inui by the FDA represents a major milestone in achieving the company’s bold vision. The inui urine analysis platform will soon be able to deliver an even broader range of diagnostic results.

“We are entering a market that has a few competitors with limited offerings, but none of them have received the type of FDA approval to deliver such a wide range of diagnostic results to both patient and physician simultaneously with our convenience and low cost,” said Reza Kazemipour, chief revenue officer at inui. “We are ensuring that our generation will be the last to know so little about our health.”
 
inui Health, headquartered in Silicon Valley, with offices in Boston, Mass., and Dubai, UAE, is a consumer medical devices company with the vision of providing consumers with universally accessible, medical-grade information anytime, anywhere. Venture backed by world class investors which include: Relay Ventures, Redmile Group, Laboratory Corporation of America (Lab Corp.), Tencent Holdings Limited, Fosun Pharma, iGlobe Partners and Three Leaf Ventures. inui is building a suite of products that help consumers detect complications early, monitor their health, share their health information with their healthcare providers to stage timely interventions and know more and worry less about their health.