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| Summary Description |
| Early cancer detection through 3-D cell-imaging |
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| Management |
| Alan C. Nelson, Founder, Chairman, and CEO;
Scarlett Spring, President;
Michael G. Meyer, Chief Technological Officer;
Thomas Neumann, Vice President for Medical Sciences;
Jon W. Hayenga, Vice President for Advanced Product Development |
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| Keywords |
| Screening, test, lung cancer, non-invasive, in vitro diagnostic, early detection, cancer, 3D imaging, biosignatures |
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| Description |
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VisionGate, Inc. has developed a revolutionary non-invasive test for the early detection of lung cancer, using its automated 3D cell-imaging platform, the Cell-CT(R), which generates high-resolution 3D biosignatures from intact cells using a sputum sample. 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. The company’s LuCED test is initially being launched for adjunctive use with low dose x-ray computed tomography (CT) screening for the early detection of lung cancer in high-risk patients, when curative therapy is still feasible. Adjunctive use of LuCED to dramatically reduce the high rate of false positive results seen with x-ray CT screening will increase the cost-effectiveness and broad utility of the approach, which has been shown in a major NIH-funded study to detect lung cancer at early stages and thereby decrease lung cancer deaths by 20% in former and current smokers. Lung cancer kills more than 160,000 people in the US alone each year, and early detection could save tens of thousands of lives annually. The Cell-CT platform is also applicable to the diagnosis of a wide range of other disorders, and VisionGate’s recent success in automating the system make it feasible for use in routine clinical medicine. |
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| Products / Services |
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. 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 expected to greatly reduce the incidence of false positives, enabling the approach to be used for cost-effective lung cancer screening on a mass scale. 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. The Cell-CT has now been fully automated, increasing its suitability for use in routine clinical medicine.
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| Technology / Differentiation |
| 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 high-resolution 3D digital images. The Cell-CT platform produce detailed 3D images of cells, which the system automatically analyzes to identify key features, or biosignatures, associated with the disease of interest. The analysis yields a score that indicates whether or not diseased cells are present. The Cell-CT system produces strikingly clear and comprehensive 3D images of the cells, enabling extremely accurate classifications. Recent advances have enabled full automation of the Cell-CT platform, which enables the system to be used in routine clinical applications that require speed, efficiency and cost effectiveness. 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. |
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| Market / Customers |
The proposed first application of LuCED is as an adjunct to reduce the false positive results from x-ray CT lung cancer screening. The National Cancer Institute?s (NCI) landmark National Lung Screening Trial of more than 53,000 current and former smokers showed that low-dose helical CT screening of these high-risk individuals reduced lung cancer deaths by 20% compared to standard chest x-rays. However, the broad utility of the approach is hampered by the high rate of false positive results seen in the study?according to the NCI, more than 96% of the positive results from low-dose CT screening over three rounds of testing turned out to be false positive findings. These false positive test results are especially problematic because they require follow-up care that results in unnecessary invasive procedures for many patients and significantly higher costs for the healthcare system as a whole, as well as causing potential psychological trauma to patients. 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.
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| Strategy |
VisionGate has developed the Cell-CT platform and its associated diagnostic tests in association of a variety of clinical partners around the globe. The company intends to follow the successful development and launch of the LuCED test with tests for other conditions that leverage the unique 3D imaging and computational capabilities of the VisionGate technology.
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| Funding |
| January 2012 ? VisionGate announced that 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) partially funded the full automation of the Cell-CT platform.
October 2011 - VisionGate closed the first $2 million tranche of a projected $3 million equity financing. The financing included both existing and new investors. |
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| Status |
| Accelerate development of Cell-CT and LuCED, and initiate clinical trials for LuCED in 2012. |
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