Topics:

Smartphone-based diagnostic device could deliver quick, at-home lab results

Tools
Biomeme's iPhone-based diagnostic device--Courtesy of Biomeme

Amid a sea of companies creating mobile medical devices, a Philadelphia startup hopes to set itself apart and deliver an innovative product that provides quick, at-home lab diagnostics on a smartphone.

Biomeme is developing a device that attaches to an iPhone and uses its computing and built-in camera functions to test for diseases and run biological diagnostics in almost any setting, Wired reports. Scientists based the product on a real-time PCR machine, a device that traditionally costs thousands of dollars and does not allow for field-based diagnostics. Biomeme's product is portable, allowing physicians to diagnose diseases on site or individuals to test common biomarkers at home.

The company's diagnostic tool, also known as a thermal cycler, latches on to the back of an iPhone and comes with a color-coded sample prep kit. A user inserts the sample into the cycler, which uses a heating and cooling process to identity the presence of a certain DNA or RNA strand. A smartphone camera measures the luminosity of the sample, and if the strand is present, the sample will glow.

Although CEO Max Perelman touts the product's ease of use and lower cost, Biomeme could face significant hurdles in getting the device approved in the U.S. Perelman cited genetics outfit 23andMe's recent scuffle with the FDA as a model to avoid, and said the company plans on launching its product overseas and ramping up R&D before it attempts to win the hearts of regulators.

"I've learned not to make strong claims about genomic testing," he told Wired. "It's a field that's still developing and these tests may be very accurate, but we're still learning about what that means in terms of predisposition to disease."

Biomeme is not the only company developing next-generation mobile healthcare products. In January, Samsung snagged FDA 510(k) clearance for its S Health mobile app that works with different health monitoring devices to track vital signs. In May, San Diego, CA-based Cue rolled out its new iOS home testing device that allows users to detect biomarkers such as testosterone, inflammation, vitamin D and fertility.

Not to be outdone, leading app maker Apple ($AAPL) also has plans for mobile diagnostic technology in the works. The company sat down with FDA officials last December to discuss its new mobile health sensors and glucometers, and recently unveiled its mobile health and fitness platform, Healthkit, for iOS 8 and Mac.

- read the Wired story

Related Articles:
Mobile medical app brings laboratory testing to the home
FDA releases details of Apple device meeting in response to FOIA request
Four months later, 23andMe's clash with the FDA remains unresolved
Samsung wrangles FDA clearance for S Health mobile app
FDA limits scope of final rule governing mobile medical apps

Filed Under