Clinical validation study results of a microRNA signature classifier lung cancer assay demonstrated that a blood-based test can significantly reduce the high false-positive rate associated high-resolution imaging, specifically with low-dose computed tomography.
The MSC Lung Cancer assay, developed by Gensignia Ltd., detected lung cancer up to two years prior to diagnosis by LDCT.
Aspects of the study were presented as a plenary talk at the AACR-IASLC Molecular Origins of Lung Cancer meeting. The study was also published in the Journal of Clinical Oncology.
Prospectively collected blood samples from 939 heavy smokers from the randomized lung cancer screening trial comparing LDCT versus observation (Multicentric Italian Lung Detection trial) were used to validate the diagnostic performance and demonstrate clinical utility of the 24 microRNA expression signature assay.
Heavy smokers from the MILD trial that were cancer-free (n=870) or diagnosed with lung cancer (n=69) were examined in this correlative study. The assay demonstrated an overall sensitivity of 87 percent for the presence of lung cancer.
For all subjects, the assay had negative predictive values of 99 percent and 99.86 percent 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 five-fold reduction in the false positive rate of LDCT-identified suspicious lung nodules in heavy smokers that did not have lung cancer.
Gensignia intends to introduce a lung cancer diagnostic test in the U.S. in 2014.
