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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

LONDON, MILAN, and SAN DIEGO, Jan. 13, 2014 /PRNewswire/ -- GENSIGNIA Ltd, a London-based, privately held molecular diagnostics company with laboratory operations in San Diego, CA, and Fondazione IRCCS, Istituto Nazionale dei Tumori (INT), Milan, a National Cancer Research Center in Italy, announced today that positive clinical validation results for the microRNA signature classifier (MSC) Lung Cancer assay were published in the Journal of Clinical Oncology (JCO). The results demonstrate for the first time that a blood-based test can significantly reduce the high false positive rate associated high resolution imaging, specifically with Low-Dose Computed Tomography (LDCT or Spiral CT), the current recommended lung cancer screening methodology for heavy smokers.  The MSC Lung Cancer assay had high sensitivity and detected lung cancer up to 2 years prior to diagnosis by LDCT. Aspects of the study results were presented on January 8th in San Diego as a plenary talk at the AACR-IASLC Molecular Origins of Lung Cancer meeting by Gabriella Sozzi, Ph.D., Professor, Head of Cancer Genomics at INT. In 2014, GENSIGNIA intends to introduce a lung cancer diagnostic test initially in the U.S.

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Prospectively collected blood samples from 939 heavy smokers from the randomized lung cancer screening trial comparing LDCT versus observation (Multicentric Italian Lung Detection [MILD] trial; INT) were used to validate the diagnostic performance and demonstrate clinical utility of the MSC Lung Cancer assay, a 24 microRNA expression signature assay. Heavy smokers from the MILD trial t
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