VisionGate, a developer of non-invasive tests for the early detection of lung cancer, has achieved full automation of its Cell-CT system, a proprietary imaging platform that generates high-resolution 3D biosignatures from intact cells.
The Cell-CT automated system uses cutting-edge optics and computational technology that has the ability to capture images rapidly, converting scanned objects into 3D digital images.
In part by a $2.6m grant from the National Institutes of Health's BRDG-SPAN programme, the Cell-CT system has been fully automated.
The company's first diagnostic application for the automated Cell-CT system is the LuCED test, a non-invasive test in development for lung cancer screening, that will be marketed along with X-ray CT scans to detect lung cancer in high-risk individuals at its earliest stages.
LuCED and the Cell-CT platform produce advanced 3D images of cells in sputum, which are then analysed to identify key features, or biosignatures, associated with potential malignancy.
VisionGate chairman and CEO Alan Nelson said the automated Cell-CT platform could revolutionise cell-based diagnostics, both by enabling early disease detection and by providing pathologists with a powerful new tool for a variety of applications.''
"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," Nelson added.
VisionGate president Scarlett Spring said attaining full automation of the Cell-CT platform helps the company 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,'' Spring added.
Mount Sinai Medical Center in New York City, US, Lung Biopsy Service director David Yankelevitz said the Cell-CT 3D imaging system could be an important tool for early detection of lung cancer, when the disease is potentially curable.
''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," Yankelevitz added.