Clinical OMICs - Issue 5 - (Page 10)

(continued from previous page) lytes and comparing spectra between patients, "we could do true correlational science," says Dr. Beresford. Biodesix based VeriStrat development on retrospective study samples and, more recently, completed a prospective trial that yielded positive results, demonstrating the test's predictive value (Lancet 2014; in press). Protein Biomarkers for Cancer Diagnostics Al Luderer, CEO of Integrated Diagnostics (Indi®), describes the power of proteomics as the ability to deliver noninvasive, molecular diagnostic tests that can be used early in the process of a patient work-up-in cancer that means before and perhaps instead of a biopsy. According to Luderer, the main limitation in developing proteomic diagnostics based on validated protein biomarkers at present is the availability of well-annotated clinical repositories of plasma samples for the clinical indication being targeted. "You need the clinical material to support discovery through validation," notes Luderer. "You need to demonstrate the patient work-up path and to show medical utilization, as that is a key element for reimbursement." Indi's first commercial proteomic test, Xpresys Lung, a blood-based diagnostic test, came on the market in October 2013. Designed to help clinicians assess lung nodules 8-30 mm in size identified on lung CT, the Xpresys Lung test determines the probability that a lung nodule is benign. A test result indicative of a high probability of being benign allows patients to enter a period of watchful waiting without the need for more invasive diagnostic studies or biopsy. Of the approximately 3 million people in the United States who present with a lung nodule on CT each year, about 200,000 will have lung cancer; the rest will have benign lung nodules. Xpresys Lung is a multiplexed protein assay designed with a high negative predictive value to rule out cancer. To develop the test, Indi measured hundreds of proteins in blood samples from individuals with benign or cancerous lung nodules in prospective studies, looking for Identifying the right subtype of kidney cancer is key to determining the right treatment. UroGenRA™, CGI's Array-CGH test for urogenital cancer, detects genomic copy number alterations with diagnostic and prognostic value. The ﬁrst application of UroGenRA™ Array CGH, UroGenRA™-Kidney, can predicts benign vs. malignant tumors and is the only CGH array for the subtyping of renal masses. Learn more at www.cancergenetics.com 10 Clinical OMICs June 12, 2014 www.clinicalomics.com http://www.cancergenetics.com/ http://ir.cancergenetics.com/ https://www.facebook.com/CancerGenetics https://twitter.com/Cancer_Genetics https://www.linkedin.com/company/cancer-genetics-inc. https://www.pinterest.com/cancergenetics/ http://www.cancergenetics.com http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Issue 5

Contents

Clinical OMICs - Issue 5