Many physicians have to take a wait and see approach when a nodule is found inside of a patient’s lung.

But VisionGate recently revealed a non-invasive LuCED test on sputum for the early detection of lung cancer may offer an alternative, non-invasive next step for patients.

More than 1.5 million people in the United States will have suspicious nodules detected incidentally in their lungs this year. Additionally, roughly one-fourth of smokers over the age of 50 will have suspicious nodules detected on a low dose CT scan done in the setting of lung screening programs. However, less than 5 percent of those nodules will be diagnosed as cancerous.

Knowing that nodules are more often not malignant, physicians are frequently faced with the quandary to “watch and wait” – see if the nodule grows over time – or perform additional, often invasive procedures.

VisionGate’s blinded clinical study of the LuCED test included 139 patient specimens and demonstrated 90 percent sensitivity to lung cancer with a 97 percent specificity finding patients without the disease.

“With each clinical milestone, we are encouraged by LuCED’s unparalleled performance,” VisionGate founder and CEO Alan Nelson, PhD said. “If LuCED were able to help confirm or rule out cancer earlier in these patients – utilizing a non-invasive method – it would transform the way these incidental nodules are managed.”

LuCED is a physician-ordered test performed at home. Three spontaneous sputum samples (phlegm) are collected and mailed to VisionGate’s laboratory in Phoenix. They are processed on VisionGate’s Cell-CT, a platform that generates high-resolution 3D images of each cell in a sputum sample. It then automatically analyzes cells to identify 700 key features, or structural biomarkers, associated with malignancy.

LuCED has the potential to be used to help triage incidental lung nodule findings, as an adjunct to low-dose CT in lung cancer screening to reduce false positives, and as a primary screener for lung cancer following FDA clearance.

In a second presentation at the WCLC, LuCED also demonstrated promise in detecting bronchial dysplasia, a precursor to cancer. When dysplasia is detected, patients become candidates for chemoprevention drug therapies such as Iloprost. VisionGate and the University of Colorado are poised to embark on a Phase III clinical trial involving Iloprost to reduce dysplasia with LuCED as the tool to detect dysplasia.