The American Society of Clinical Oncology (ASCO) Recognizes Gensignia's Research in Lung Cancer Screening

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Jan 22, 2015, 06:00 ET

SAN DIEGO and MILAN, Jan. 22, 2015 /PRNewswire/ -- Gensignia scientific co-founders' research has been recognized in Clinical Cancer Advances 2015: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology published online in the Journal of Clinical Oncology (JCO) on January 20, 2015.¹

The ASCO report states: "Additional recent research will help improve the efficacy of low-dose CT lung cancer screening and reduce potential harms by identifying the populations that stand to benefit the most from screening, and developing ways to reduce false-positive screening results."

"A recent study addressed the problem of false-positive findings by developing a new diagnostic blood test for lung cancer (this study was funded in part by a grant from the NIH).² The experimental test is noninvasive; it only requires a blood sample, rather than a potentially painful and risky biopsy. By analyzing molecules called microRNA in a patient's blood, physicians can determine if the abnormality detected on a scan is truly lung cancer. In a large validation study, combination of the microRNA test and low-dose CT resulted in a five-fold reduction of false-positive screening rates (from 19.4% to 3.7%)."

Gensignia's scientific co-founders, Gabriella Sozzi, Ph.D., Mattia Boeri, Ph.D., and Ugo Pastorino, M.D., are attributed with the discovery that the evaluation of certain microRNAs in the blood of subjects at high risk for lung cancer (heavy smokers) can be used to determine, with improved accuracy, the likelihood that lung cancer is developing or has already developed. The discovery was made in the context of screening high risk subjects using routine low-dose computed tomography (LDCT) scans for the presence of potentially cancerous lung masses. Their pioneering research was published in the Proceedings of the National Academy of Sciences (PNAS) in 2011.³

The microRNA assay was further validated in a large clinical study completed in 2013 and its results published in JCO in January 2014.²^,⁴ This clinical validation was a correlative study from the Multicenter Italian Lung Detection (MILD) Trial that was published in the European Journal of Cancer Prevention in 2012.⁵ The authors concluded from the results of the clinical validation study that the MSC Lung Cancer assay had predictive, diagnostic, and prognostic value and reduced the high false-positive rate of LDCT, thus potentially improving the efficacy of lung cancer screening.

"We are honored to have Drs. Sozzi, Boeri and our team's research included by ASCO as one of the most important cancer research advances in 2014," stated Ugo Pastorino, M.D., Scientific Director, Fondazione IRCCS Istituto Nazionale dei Tumori, and Gensignia co-founder.

Lee R. McCracken, Gensignia's Chief Executive Officer, further commented, "We are truly appreciative of ASCO's acknowledgment of Gensignia's clinical research and are committed to bringing the Gensignia™ miRNA Signature Classifier (MSC) Lung Cancer Test into clinical practice to improve lung cancer detection worldwide."

About Gensignia
Gensignia Life Sciences, Inc. (Gensignia) is a privately held molecular diagnostics company advancing development and global commercialization of the Gensignia™ MSC Lung Cancer Test in 2015, and additional diagnostic tests in the future, through the establishment of a clinical laboratory in San Diego.

For more information visit www.gensignia.com.

Forward Looking Statements
Statements in this press release about the Company's expectations, applications of its technology, markets, launch of tests and other statements that are not historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's current beliefs, assumptions, estimates and projections. Actual results could differ materially from those projected in the forward-looking statements for various reasons, including risks associated with product and test development, test transfer to contracting labs, government regulation, market acceptance, limited commercial experience and dependence on key personnel and financing.

Contact
Clyde Shores
[email protected]

References
¹Masters, G., et al, Clinical Cancer Advances 2015: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology, JCO.2014.59.9746; Published Ahead of Print on January 20, 2015.
²Sozzi G, Boeri M, Rossi M, et al: Clinical Utility of a Plasma-Based miRNA Signature Classifier Within Computed Tomography Lung Cancer Screening: A Correlative MILD Trial Study. J Clin Oncol 32:768-773; published online on January 13, 2014.
³Boeri, M., et al., MicroRNA Signatures In Tissues And Plasma Predict Development And Prognosis Of Computed Tomography Detected Lung Cancer. PNAS, 2011. 108(9): p. 3713-8.
⁴Massion, Biomarkers To The Rescue In A Lung Nodule Epidemic. J Clin Oncol 32:725-726; Published online February 10, 2014.
⁵Pastorino U, Rossi M, Rosato V, et al: Annual Or Biennial CT Screening Versus Observation In Heavy Smokers: 5-Year Results Of The MILD Trial. Eur J Cancer Prev 21:308-315, 2012.

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