SAN DIEGO, Oct. 12, 2015 /PRNewswire/ -- Gensignia Life Sciences, Inc. (Gensignia) announced today that it received certification under the Clinical Laboratory Improvement Amendments (CLIA). The State of California has granted the company initial CLIA clinical laboratory license under the "deemed status" provision of the U.S. Department of Health and Human Services (HHS) Center for Medicare and Medicaid Services (CMS).
"With CLIA certification we have successfully executed on our plan to establish a clinical laboratory in San Diego for the Gensignia™ miRNA Signature Classifier (MSC) Lung Cancer Test and future diagnostic tests," said Lee R. McCracken, Gensignia's Chief Executive Officer. Lee further commented, "following the completion of the technology transfer from Istituto Nazionale dei Tumori, (INT) in Milan and CLIA certification, we have accomplished major milestones supporting our commitment to advance the Gensignia™ MSC Lung Cancer Test towards improving lung cancer detection worldwide."
Gensignia's scientific co-founders, Ugo Pastorino, M.D., Gabriella Sozzi, Ph.D. and Mattia Boeri, Ph.D., at INT, 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 improve the accuracy of detection of lung cancer. The discovery was made in the context of early detection of lung cancer in 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 2011.1
The MSC Lung test was initially validated in a large clinical cohort of the Multicenter Italian Lung Detection (MILD) Trial.2 The correlative study was completed in 2013 and its results published in the Journal of Clinical Oncology (JCO) in January 2014.3,4 This research was recognized in Clinical Cancer Advances 2015: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology published online in JCO on January 20, 2015.5 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."
Gensignia Life Sciences, Inc. (Gensignia) is a privately held molecular diagnostics company advancing development and global commercialization of the Gensignia™ MSC Lung Cancer Test and additional diagnostic tests in the future.
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.
1 Boeri, 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.
2Pastorino 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.
3Sozzi 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.
4Massion, Biomarkers To The Rescue In A Lung Nodule Epidemic. J Clin Oncol 32:725-726; Published online February 10, 2014.
5Masters, 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.