
A new study has revealed that a new mechanized three-dimensional (3D) cell-imaging platform could effectively identify lung cancer in sputum samples with high rates of sensitivity and specificity.
The Cell-CT technology, developed by VisionGate, Inc. (Sydney, Australia), a company developing a noninvasive test for the early detection of lung cancer, utilizes an approach called optical projection tomography to image cells in 3D. A cell is transferred through the Cell-CT’s glass micro-capillary by applying pressure to a gel that inserts cells. As the capillary spins, the cell is scanned from various angles, providing a series of pseudo-projection images.
These images are then merged together using a technique known as filtered back-projection, producing the final 3D cell volume.
These new findings were presented at the International Association for the Study of Lung Cancer (IASLC) 15th World Conference on Lung Cancer, held October 27-30, 2013, in Sydney (NSW, Australia).
The pilot study looked at and examined sputum samples from patients with lung cancer and from healthy individuals. The findings showed that the Cell-CT platform and the LuCED sputum test successfully detected the existence or nonexistence of lung cancer cells in patient sputum from an impulsive cough.
Of the 53 individuals studied up till now, LuCED and the Cell-CT achieved a sensitivity of more than 95% and specificity of 99.8%. The high sensitivity demonstrates that the Cell-CT detects most tumors, and the high specificity means that the rate of false-positive readings is considerably low. This indicates a far greater accuracy than has been previously shown with any other lung cancer-screening test.
“Lung cancer remains the leading cause of cancer death in the US, primarily because it is not detected until after the cancer has spread. Results to date from this ongoing clinical study suggest that LuCED and the Cell-CT correctly identify more than nine out of every 10 cases of lung cancer with virtually no false-positive results, supporting the goal of developing a new lung cancer screening paradigm that is both accurate and cost-effective,” said founder and CEO of VisionGate, Alan Nelson, PhD.
The automated Cell-CT platform generates exceptionally clear and detailed 3D digital images of the cells contained in sputum. It uses sophisticated algorithms to identify the existence or nonexistence of cell biosignatures tied to malignant or normal status, making it possible to determine with a high rate of accuracy whether a patient has cancer. Low-dose computed tomography (CT) screening can detect lung cancer at early stages and save lives. However, CT screening has an exceedingly high rate of false-positive results, which can lead to expensive and invasive follow-up procedures. The large US National Cancer Institute (NCI; Bethesda, MD, USA) National Lung Screening Trial revealed that more than 96% of the “positive” results from CT screening were actually false-positives. Consequently, its use is recommended only in the highest-risk individuals. The potential ability of VisionGate’s Cell-CT platform to noninvasively and cost-effectively confirm or denounce positive findings from CT scans would make widespread use of lung cancer screening a more achievable possibility.
“The urgency of developing accurate, cost-effective tools for early detection of lung cancer is highlighted by the thousands of preventable lung cancer deaths each year. These data showing that the Cell-CT platform can detect lung cancer with high accuracy from sputum samples in patients at all stages of the disease, as well as identifying those who are cancer-free, is very encouraging. We look forward to continuing to work with VisionGate to enlarge the study population and generate the data needed to advance development of this promising lung cancer screening test,” said director of clinical research, Cancer Treatment Centers of America Western Regional Medical Center (Goodyear, AZ, USA), Glen J. Weiss, MD.
Previous research had verified that analyzing cells in sputum could be useful in the early detection of lung cancer. However, the characteristically poor sensitivity of raw sputum analysis and the labor-intensive nature of the process made it unfeasible for widespread use. The Cell-CT’s high-resolution 3D technology and its automated image analysis software for the first time make a cell-based diagnostic approach using sputum samples logistically not only possible, but cost-effective.
“We soon expect to supplement these exciting efficacy results with peer-reviewed economic analysis data that confirm the cost-effectiveness of our approach. We also are expanding our collaborative efforts with a variety of institutions as we focus on generating the additional data needed to gain FDA regulatory clearance of LuCED and the Cell-CT platform for adjunctive use with X-ray CT screening, and then possibly as a stand-alone test for lung cancer screening that would be readily available at moderate cost to the broader population,” said president of VisionGate, Scarlett
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