VisionGate, Inc., a company developing a revolutionary non-invasive test for the early detection of lung cancer and other applications, today reported that it has achieved full automation of its Cell-CT™ system, a proprietary imaging platform that generates high-resolution 3D biosignatures from intact cells. Development of the fully automated system was funded in part by a $2.6 million grant from the National Institutes of Health's (NIH) BRDG-SPAN program (Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies). Separately, VisionGate announced that it will be presenting at the OneMedForum 2012 Finance Conference in San Francisco on Tuesday, January 10, 2012.
VisionGate's first diagnostic application for the automated Cell-CT system is the LuCED® test, a non-invasive test in development for lung cancer screening. LuCED will initially be marketed in conjunction with x-ray computed tomography (CT) scans to detect lung cancer in high-risk individuals at its earliest stages, when curative therapy is still feasible.
"Achieving full automation of the Cell-CT system is a major milestone for VisionGate," said Alan Nelson, PhD, Chairman and CEO of VisionGate. "To realize the exceptional potential of this breakthrough 3D imaging technology for disease diagnosis and prognosis in large patient populations, it had to be developed as part of a fully automated system that can process patient samples rapidly and efficiently. We believe the automated Cell-CT platform could revolutionize cell-based diagnostics, both by enabling early disease detection and by providing pathologists with a powerful new tool for a wide range of applications. We are grateful for the support from the NIH that helped us reach this critical goal."
Dr. Nelson continued, "In the near-term, automation of the Cell-CT platform sets the stage for submission of our first applications to the Food and Drug Administration (FDA) later this year for regulatory review of LuCED."
In a July 2011 presentation at the International Academy for the Study of Lung Cancer's 14th World Conference on Lung Cancer, VisionGate showed how LuCED and the Cell-CT platform can accurately detect cancer cells in sputum samples from individuals at high risk of lung cancer.
Scarlett Spring, President of VisionGate, noted, "Achieving full automation of the Cell-CT platform is another on-time milestone in our plans to file for regulatory approval of the LuCED test during 2012. It also complements our recently announced strategic partnerships for clinical assessment of the LuCED technology used adjunctively to reduce the high rate of false positive cases that result from x-ray CT lung cancer screening. We expect these partnerships will provide valuable data to further advance our LuCED regulatory strategy."
LuCED and the Cell-CT platform produce 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 score that indicates whether or not cancer cells are present. The Cell-CT system produces strikingly clear and comprehensive 3D images of the cells, enabling extremely accurate classifications. LuCED is initially being developed for use in conjunction with x-ray CT screening, which has been shown to reduce lung cancer deaths in high-risk individuals, but which also has a high rate of false positive results. LuCED is expected to greatly reduce the incidence of false positives, potentially enabling the approach to be used for cost-effective lung cancer screening on a mass scale.
"The Cell-CT 3D imaging system could be a valuable tool for early detection of lung cancer, when the disease is potentially curable," said David Yankelevitz, MD, Professor of Radiology and Director of the Lung Biopsy Service at the Mount Sinai Medical Center in New York City. "But the large number of individuals at high risk for developing this disease, which kills more than 160,000 Americans annually, mandates that screening be accurate, efficient and cost effective. Automation of this innovative diagnostic tool is an important step towards achieving these performance requirements, and I look forward to seeing the results of the clinical studies that VisionGate will conduct later this year."
The Cell-CT automated system harnesses the power of cutting-edge optics and computational technology that have the capability to capture images very rapidly, rendering scanned objects into 3D digital images. All components of the Cell-CT system have been custom designed by VisionGate's scientists and engineers. The technology is covered by 66 issued patents around the globe.
VisionGate was awarded an NIH BRDG-SPAN grant for automation of the Cell-CT platform in recognition of its potential to "improve human health and create significant value and economic stimulus." The BRDG-SPAN program aims to accelerate the transition of research innovations and technologies toward the development of products or services that will improve human health, help advance the mission of NIH and its Institutes and Centers, and create significant value and economic stimulus. This program also aims to foster partnerships among a variety of R&D collaborators working toward these aims.
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