VisionGate sets sights on FDA approval for noninvasive lung cancer Dx

As lung cancer diagnostics pick up steam in the industry, Phoenix, AZ-based VisionGate is looking to distinguish itself from the pack with its noninvasive test for the disease. And the company is counting on FDA approval for its innovative technology to take business to the next level.

VisionGate is in discussions with the agency about moving forward with approval for its lung cancer test, dubbed LuCED, CEO Dr. Alan Nelson told FierceDiagnostics. The company wants its test approved as a class III PMA, similar to a pap smear of the lungs, and VisionGate is gearing up to announce U.S. and international-based clinical trials that involve "very large" patient populations, he said.

VisionGate's LuCED test runs through its proprietary Cell-CT platform, which automatically reads the test and produces a diagnostic result. The company owns all the technology to run the system from the beginning of sample collection until the release of results.

VisionGate CEO Alan Nelson

But to obtain the infrastructure it needs to accommodate testing volume and fuel its upcoming trials, VisionGate needs some cash--and the company is mulling an IPO to ramp up operations.

"This is a very good time to be scaling up the company for the future market that we think is very substantial," Nelson said. "We're not committed to a particular timeline but we're completing everything that's required. It would appear that we're well-positioned and we're considering that option."

The company has already charted progress this year, planning to move into a new, 15,000-square-foot space with a CLIA-licensed lab in Phoenix. VisionGate is also exploring other avenues for expansion, considering using its Cell-CT technology to work with pharma companies on drug development and personalized medicine, Nelson said. The company is also planning to build out its portfolio, adding tests for breast cancer, circulating tumor cells in the blood, esophageal cancer and bladder cancer.

"We've had a laser focus on lung cancer screening and we will deliver on that front. That means developing an international and national footprint for lung cancer screening with a noninvasive test. That business alone is a multibillion dollar business," Nelson said. "It's all about new execution." -- Emily Wasserman (email | Twitter)