VisionGate to Present Early Lung Cancer Detection Data at ASCO

LuCED® Test has Potential to Detect Cancer with a Cough

Phoenix, AZ – May 7, 2014 – VisionGate®, Inc., an in vitro diagnostics company that is developing a revolutionary, non-invasive test for the early detection of lung cancer and other applications, today announced that data on sensitivity and specificity of its LuCED lung cancer detection test will be presented at the American Society of Clinical Oncology’s (ASCO) 50th annual conference at McCormick Place in Chicago. ASCO runs from May 30 to June 2.

On Saturday, May 31, results from “Early Detection of Lung Cancer Based on the Three-Dimensional, Morphometric Analysis of Cells from Sputum,” will be presented during a poster session from 1:15 to 5:00 p.m. in S Hall A2, poster board 155.

The new data on this new approach to lung cancer detection follows the April 30 Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) vote against coverage for annual screenings using low-dose CT scans for high-risk lung cancer patients.

“We applaud the numerous physicians and advocates who have dedicated time, funding and energy to generate awareness around the benefits of early lung cancer detection and advancements in lung cancer screening. CT screening programs are an important part of lung cancer screening, but recent concerns about high false positive rates associated with CT screening programs highlight the significant need for additional data to help physicians identify patients who actually have lung cancer, rather than a benign lesion,” VisionGate Founder and Chief Executive Officer Alan C. Nelson, PhD, said. “We look forward to working alongside both the medical community and lung cancer advocates to develop reliable, non-invasive, cost-effective alternative options to precede, supplement or follow low-dose CT scans.”

In December 2013, new guidelines issued by the U.S. Preventative Services Task Force recommended annual low-dose CT screening for lung cancer in adults aged 55 to 80 who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. The MEDCAC expressed uncertainty that the benefit of these CT screenings did not outweigh the harm of false positives or radiation exposure.

The LuCED test incorporates VisionGate’s Cell-CT® automated system that harnesses the power of cuttingedge optics and computational technology that have the capability to capture images very rapidly, rendering scanned objects into 3D digital images. For this particular study, the Cell-CT platform produces clear, detailed, 3D images of cells in sputum, which the system automatically analyzes to identify key features, or biosignatures, associated with potential malignancy. The analysis yields a high score when cancer cells are present.

In the United States, approximately 160,000 people die annually from lung cancer, which represents about 27% of all cancer deaths.

About VisionGate

VisionGate, Inc. is led by Dr. Alan Nelson, physicist, bioengineer and entrepreneur who developed the world’s first and only automated screening test to detect cervical cancer, marketed today as FocalPoint by Becton Dickinson. VisionGate offers the first automated 3D cell imaging platform, the Cell-CT, which computes highresolution 3D biosignatures from intact cells. The company’s first implementation of the Cell-CT is the LuCED test, initially being developed as a CLIA lab developed test for adjunctive use with low dose x-ray computed tomography (LDCT) screening for the early detection of lung cancer in high-risk individuals. Adjunctive use of LuCED to better manage the high rate of false positive results in CT screening could increase the utility and cost effectiveness of the approach, which has been shown to decrease lung cancer deaths in high-risk patients. VisionGate is headquartered in Phoenix, Arizona, and has a research and development office in Seattle, Washington. It currently holds 106 issued patents. For more information about VisionGate, visit www.visiongate3d.com.

About Lung Cancer

According to the American Cancer Society, lung cancer is by far the leading cause of cancer death among both men and women. Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). In men, prostate cancer is more common, while in women breast cancer is more common. The American Cancer Society estimates that in 2014 in the United States about 224,210 new cases of lung cancer (116,000 in men and 108,210 in women) will be diagnosed, and an estimated 159,260 people will die from lung cancer (86,930 in men and 72,330 among women), accounting for about 27% of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.