PARIS -- (Marketwire) -- 03/21/13 -- Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that it has launched a registry study to determine the impact of Cellvizio optical biopsies on the diagnosis of lung cancer, the leading cause of cancer death in the world. Previous studies have shown that Cellvizio's real-time, cellular-level views of distal lung tissue extend the reach and improve the diagnostic accuracy of bronchoscopy procedures, reducing the need to repeat invasive, expensive diagnostic tests.
The registry will include 200 patients enrolled at up to ten leading U.S. lung centers.
"Data from the recently-published National Lung Screening Trial (NLST) suggest that lung cancer screening with low-dose CT chest scans in long-term smokers leads to early detection and improved survival. However, the very high false positive rate associated with CT scans often results in additional diagnostic procedures to evaluate a lesion," said Sandhya Khurana, MD, Associate Professor of Medicine, Pulmonary Diseases, and Critical Care at the University of Rochester Medical Center (URMC). Dr. Khurana is one of the Principal Investigators of the Cellvizio U.S. lung registry. "Our goal is to accurately diagnose these lesions by using the least invasive, lowest risk and highest-yield tests."
According to the NLST, a study sponsored by the National Institutes of Health and originally published in the New England Journal of Medicine, 96.4 percent of CT scans generated false positives for lung cancer. Based on a recent analysis of the data, 24 out of every 100 patients screened will have lesions and only one of the 24 will eventually be diagnosed with lung cancer. Getting to a final diagnosis can be quite taxing on patients because of the limitations of traditional bronchoscopes and tissue biopsy techniques. Recent studies have found that 31% of lung lesion biopsies need to be repeated(i) due to radiologists and pathologists requesting additional information.
"Cellvizio offers a potential new way for pulmonologists to achieve accurate real-time characterization of tissue as benign or malignant, particularly in areas of the lung not directly accessible to the bronchoscope," Dr. Khurana said. "Using a navigational bronchoscopy system to guide physicians to the suspicious lesions could further enhance diagnostic accuracy of optical biopsies and decrease the need for additional invasive diagnostic procedures. We are excited to be a part of this important trial."
Dr. Khurana and Dr. Michael Nead, study co-investigator, enrolled the first Cellvizio lung registry patient at URMC earlier this month.
The U.S. lung registry study is a prospective observational study which will aim to refine the criteria to differentiate healthy versus diseased tissue in patients with discrete lung lesions. Once these criteria have been refined, the diagnostic parameters and the reproducibility of optical biopsies will be assessed. Investigators will also use the registry to characterize acute lung rejection in patients with transplanted lungs. The Food and Drug Administration-cleared AlveoFlex probe is 1.4 mm in diameter and works with a standard bronchoscope.
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