Biosense's new healthcare app for iPhone under FDA scanner

BANGALORE: A healthcare application developed by a Mumbai-based medical technology firm, Biosense, which helps detect over a score of diseases from a urine sample, has come under the scanner of the Food and Drug Administration in the US.

Biosense has been asked to clarify why it did not seek prior approval from the regulator before the release of its iPhone app, uChek, the first time where a mobile healthcare app developed by an Indian company has come under the purview of regulators. "Since your app allows a mobile phone to analyse the dipsticks, the phone and device as a whole functions as an automated strip reader," said James Woods, deputy director of patient safety and product quality for the FDA office, which regulates in-home and laboratory diagnostic tests in a letter addressed to the company. "Any company intending to promote its device for use in analysing, reading, or interpreting, these dipsticks need to obtain clearance for the entire urinalysis test system."

Biosense has a month to respond to the query raised last week.

Myshkin Ingawale, 29, co-founder of Biosense, who first unveiled the product in February at the global Technology, Entertainment, Design conference in California, said his company will seek FDA registration for the product as it provides credibility and builds confidence among patients.

"We are in communication with the FDA as per their latest letter, and will be working closely with them over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world," said Ingawale, who co-founded the company with four friends in 2008.

UChek, a urine analysis system, can diagnose conditions from diabetes, urinary tract infection and hepatitis based on snapshots of urine samples.

Experts are of the view that although such technologies are non-invasive, inaccurate information can lead to serious consequences. "FDA approval is important as it establishes that the technology is good and makes it very difficult for competitors to make me-too products," said Pradip Majumder, chief scientific officer at Mitra Biotech, a Bangalore-based company that focuses on personalised cancer therapy.

In recent months, a number of mobile applications that offer healthcare services have received approval from the FDA. Last December, AliveCor received clearance for iPhone app that works like a mobile heart monitor. Another company, Cardiac Designs, received approval from FDA for a similar product in March this year.

Investors say queries by regulators about smartphone health apps, especially in direct-to- consumer diagnostics is a positive development.

"I am enthusiastic about direct-to-consumer diagnostic devices. Investors who understand the value it provides for patients are willing to invest and wait for three years for such approvals," said Ajit Singh, partner at venture capital fund Artiman Ventures, which manages a global corpus of about 4,100 crore.

"When these companies get FDA approval, their valuation rises," said Singh, whose fund has backed Click Diagnostics, which specialises in infectious diseases diagnostics. "I prefer to bet at an early stage."

In March, Biosesene received early funding of 2.7 crore from GSF Accelerator and Insitor Fund, a social venture capital fund. India is slated to become one of the biggest players in the global app market, according to Internet and Mobile Association of India that estimates that the industry will be valued at 1,800 crore by year end.