News | January 26, 2015

New diagnostic blood test plus low-dose CT reduces false-positive rate

Gensignia, lung cancer, LDCT, microRNA, ASCO

Image courtesy of Gensignia Life Sciences.


January 26, 2015 — Research by Gensignia’s scientific co-founders 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 Jan. 20, 2015.

The ASCO report states: "Additional recent research will help improve the efficacy of low-dose CT [computed tomography] 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). 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 percent to 3.7 percent)."

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 research was published in the Proceedings of the National Academy of Sciences (PNAS) in 2011.

The microRNA assay was further validated in a large clinical study completed in 2013 and its results published in JCO in January 2014. 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. 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.

For more information: www.gensignia.com


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