GENSIGNIA's miRNA signature classifier (MSC) - Lung Cancer Test is a molecular diagnostic assay to detect lung cancer-related microRNA in plasma.
microRNA BIOMARKERS
In recent years circulating miRNAs have become attractive candidates to be used as cancer biomarkers.
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CLASSIFIERS
Our Scientific team has identified miRNA signatures to address the unmet clinical need for a molecular marker-based non-invasive test for early diagnosis of lung cancer in subjects at risk.
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REFERENCES
See key publications related to our discovery and the related field.
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Key Publications

Sozzi, G. et al., Clinical Utility of a Plasma-Based miRNA Signature Classifier Within Computed Tomography Lung Cancer Screening: A Correlative MILD Trial Study, JCO published online on January 13, 2014; DOI:10.1200/JCO.2013.50.4357.

Abstract

Purpose: Recent screening trial results indicate that low-dose computed tomography (LDCT) reduces lung cancer mortality in high-risk patients. However, high false-positive rates, costs, and potential harms highlight the need for complementary biomarkers. The diagnostic performance of a noninvasive plasma microRNA signature classifier (MSC) was retrospectively evaluated in samples prospectively collected from smokers within the randomized Multicenter Italian Lung Detection (MILD) trial.

Patients and Methods: Plasma samples from 939 participants, including 69 patients with lung cancer and 870 disease-free individuals (n = 652, LDCT arm; n = 287, observation arm) were analyzed by using a quantitative reverse transcriptase polymerase chain reaction–based assay for MSC. Diagnostic performance of MSC was evaluated in a blinded validation study that used prespecified risk groups.

Results: The diagnostic performance of MSC for lung cancer detection was 87% for sensitivity and 81% for specificity across both arms, and 88% and 80%, respectively, in the LDCT arm. For all patients, MSC had a negative predictive value of 99% and 99.86% for detection and death as a result of disease, respectively. LDCT had sensitivity of 79% and specificity of 81% with a false-positive rate of 19.4%. Diagnostic performance of MSC was confirmed by time dependency analysis. Combination of both MSC and LDCT resulted in a five-fold reduction of LDCT false-positive rate to 3.7%. MSC risk groups were significantly associated with survival (χ12 = 49.53; P < .001).

Conclusion: This large validation study indicates that MSC has predictive, diagnostic, and prognostic value and could reduce the false-positive rate of LDCT, thus improving the efficacy of lung cancer screening.

Pastorino, U. et.al. Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial. Eur J Cancer Prev. 2012 May;21(3):308-15.

Fortunato O. et. al. Assessment of Circulating microRNAs in Plasma of Lung Cancer Patients. Molecules 2014, 19, 3038-3054.

Massion, P., Biomarkers to the Rescue in a Lung Nodule Epidemic. JCO March 10, 2014 vol. 32 no. 8 p. 725-726.