BOSTON, Mass. — Often known as the silent killer, kidney disease impacts an estimated 35 million Americans.

Now, there's a new Smartphone app aiming to help break down barriers and diagnose patients early.

Paula LeClair is with a company called Healthy.io. A few weeks ago their app, "Minuteful Kidney: Home Urine Test," received FDA clearance. No trip to the doctor's office is needed.

"What we want to do is test everyone early and the earliest easiest way to do that is through the urine," LeClair said.

Instead, using a urine sample at home, people can run a screening test using their smartphone. Results usually appear in less than a minute.

"It’s not until late stages that they become symptomicatic, if they become, they are close to needing dialysis or a transplant," LeClair added.

There are broader implications to all this as well. People of color are four times more likely to have chronic kidney disease. The hope is that by breaking down barriers, especially for people who may not have access to a primary care provider, early detection can still be possible.

"It's such a large problem," she noted.

While this is the first app of its kind to be FDA approved for at-home kidney screenings, it's part of a growing list of FDA-approved mobile medical apps, including EKG readers, blood-pressure cuffs and pulse oximeters.