Molecular Blood Test Detects Lung Cancer

Recent screening trial results indicate that low-dose computed tomography (LDCT) reduces lung cancer mortality in high-risk patients, but high false-positive rates, costs, and potential harms highlight the need for complementary biomarkers.

Scientists from the Istituto Nazionale dei Tumori (Milan, Italy) and their colleagues prospectively collected blood samples from 939 heavy smokers from the randomized lung cancer screening trial comparing LDCT versus observation from the Multicentric Italian Lung Detection [MILD] trial. The microRNA signature classifier (MSC) Lung Cancer assay is a 24-miRNA expression signature assay.

Total RNA was extracted from samples with the mirVana PARIS Kit (Life Technologies, Carlsbad, CA, USA). The miRNA expression was determined by using the Life Technologies’ Multiplex Pools Protocol on custom-made microfluidics card containing the 24 miRNAs spotted on duplicates. Plasma samples obtained before or at diagnosis from the 939 participants across LDCT and observational groups were analyzed by using a real-time reverse transcriptase polymerase chain reaction (RT-PCR)–based assay with a prespecified MSC algorithm of low, intermediate, and high risk of cancer groups.

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 five-fold reduction in the false positive rate of LDCT-identified suspicious lung nodules in heavy smokers that did not have lung cancer.

The authors concluded that MSC had satisfactory diagnostic performance for early detection of lung cancer within this large validation study of plasma samples prospectively collected from 939 participants enrolled onto the randomized MILD screening trial. Gabriele Cerrone is the founder and executive chairman of GENSIGNIA (San Diego, CA, USA), the molecular diagnostic company that intends to introduce a lung cancer diagnostic test initially in the USA in 2014. Mr. Cerrone said, “In combination with a LDCT, the MSC Lung Cancer assay significantly reduces the false positive rate, which can translate in substantial savings for the global healthcare system by avoiding the need for additional workups and scans required to confirm diagnosis.” The study was published on January 13, 2014, in the Journal of Clinical Oncology.

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Istituto Nazionale dei Tumori
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GENSIGNIA