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Simple blood test can detect lung cancer with high sensitivity and specificity - results from large clinical validation study published in the Journal of Clinical Oncology
Date:1/13/2014

hat were cancer-free (n=870) or diagnosed with lung cancer (n=69) were examined in this correlative study. The MSC Lung Cancer assay demonstrated an overall sensitivity of 87% for the presence of lung cancer. For all subjects, the MSC Lung Cancer assay had negative predictive values (NPVs) of 99% and 99.86% for detection and death-by-disease (lung cancer), respectively, indicating the test's high specificity for correctly identifying subjects without lung cancer.  The high specificity of the MSC Lung Cancer assay resulted in a 5-fold reduction in the false positive rate of LDCT-identified suspicious lung nodules in heavy smokers that did not have lung cancer.

"The 5-fold reduction in false positives obtained by combining the MSC Lung Cancer assay to the results of the LDCT scan is of great clinical relevance in the context of reducing the false positive rate and the potential side effects associated with repeated LDCT scans or other unnecessary invasive diagnostic follow-ups," stated Dr. Ugo Pastorino, Head of Thoracic Surgery Unit, Chairman of Department of Surgery, Istituto Nazionale dei Tumori, Milan, Italy.

This correlative study in lung cancer is the first of its kind, clinically validating a biomarker using prospectively collected blood samples from a large randomized lung cancer screening trial. In addition to a significant reduction in the rate of false positive results, the performance of the MSC Lung Cancer assay was independent of the stage of lung cancer and time prior to detection of cancer with LDCT (up to two years prior). This suggests additional potential utility for diagnosis and early detection with the MSC Lung Cancer assay.

"We have developed a minimally invasive molecular diagnostic assay that quantifies the expression of specific miRNAs which are freely circulating in blood and indicate the presence of lung cancer," stated Gabriella Sozzi'/>"/>

SOURCE GENSIGNIA Ltd
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