The search for a screening tool that can help detect lung cancers at early stages has been a focus of research aimed at the leading cause of cancer death in the United States. While much excitement has been created by the performance of helical computed tomography (CT) scans in a large National Cancer Institute (NCI) trial that ended last year, work continues on creating imaging technology that clinicians can use for improved diagnoses.
VisionGate, Inc is a 10-year-old company that has developed the Cell-CT™ system, which produces 3-dimensional (3D) images of cell samples without the use of x-rays. In September, VisionGate opened a laboratory in Phoenix, Arizona, near 1 of its academic research partners. The company is working on studies needed to support an application with the FDA to bring the technology to market.
Here, Thomas Neumann, MD, vice president for Medical Sciences at VisionGate, discusses the technology.ONC: Please describe how the Cell-CT technology works.Neumann:
VisionGate named its instrument the “Cell-CT” because it is used to image cells with techniques that are generally applied in CT. However, the Cell-CT does not work with x-rays; it employs light sources common in standard microscopes. The Cell-CT is used to create high-resolution 3-dimensional (3D) images of cells for the diagnosis of important diseases, such as cancer.
Briefly, suspensions of cells isolated from human specimens are fl owed through a rotating glass capillary tube smaller than a human hair. One by one, the rotating cells pass by a microscope objective that images each cell from hundreds of different angles. The images are then automatically reconstructed, using CT, into 3D objects of unsurpassed precision, allowing for improved detection of cellular changes specific to certain diseases.
Analysis can be done through visual examination of the 3D images by a cytologist or cytopathologist, or automatically by using computer programs that are trained to recognize cell features of diagnostic value. Principally, any cellular specimens can be imaged on the Cell-CT. Sputum samples, which contain cells shed from the inner lining of the lungs, are used for lung cancer screening. To produce these specimens, patients are asked to expectorate phlegm (sputum) from their lungs, a collection procedure that is both easy and noninvasive.Would the Cell-CT replace x-ray CT scans or be used to enhance the results of current technology?
These 2 imaging techniques are complementary rather than competitive. The Cell-CT can detect cancer cells in sputum, whereas x-ray CT is used to discover suspicious nodules in the lung. The Cell-CT will not replace x-ray CT. Lung cancer usually develops over decades, often as a result of prolonged exposure to carcinogenic substances due to smoking. The features of the epithelial cells that comprise the inner lining of the lungs are indicative of the cancer risk. A larger degree of abnormality in the cells corresponds with an increased likelihood to develop lung cancer in a certain time window. Thus, the Cell-CT is not only trained to detect cancer cells in lung cancer patients, it can also characterize the degree of precancerous changes in cells from at-risk patients. Since the Cell-CT test is noninvasive, economical, and easy, it can be used repeatedly. Cytology is known for very high specificity—ideal for combination with x-ray CT, which is associated with a high false-positive rate. An efficient pretest based on automated sputum cytology would significantly improve the cost effectiveness of x-ray CT.In what stage of development is the Cell-CT technology?
The current generation Cell-CT was developed for applications in scientific research and small clinical studies. A number of published studies in the biomedical field have established the superiority of the Cell-CT. Several of our instruments have been purchased by research institutions. We are currently developing the next generation of Cell-CTs that will serve as diagnostic platforms in large-scale laboratories. The new-generation Cell-CT will analyze human specimens automated and with high throughput.Please discuss the $2.6 million grant the company won from the National Institutes of Health (NIH).
The NIH has designed a program called Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN). This program provides significant financial support for accelerating the market introduction of technologies with the ability to lead to a significant breakthrough in medicine, combined with a significant business potential in United States and/or global markets. The data on Cell-CT performance submitted to the NIH convinced the review panel of the impact of VisionGate’s technology. Other important review criteria were the research and development strategy, and the business plan, as well as the qualification of the team. VisionGate was selected among 10 awardees for this program.What studies/trials are underway or planned?