Authors' recommendations: Background Cancer is the second most common cause of death in the United States. In 2015, it was estimated that cancer would affect 1,658,370 Americans, causing death in approximately 589,430 cases. The age-adjusted death rate from cancer in the United States from 2008 to 2012 was 171.2 per 100,000 individuals (SEER, 2016). Of men and women born in the United States today, approximately 40% will be diagnosed with cancer at some stage in their lives. As cancer is essentially a disease in which dysfunctional genetic alterations lead to abnormal cell growth and division, genetic and genomic testing is of great interest in the evaluation of cancer. Assessment of the particular genetic alterations present in an individual's tumor may provide information of interest in diagnosis, prognosis, or targeted treatment. Comprehensive tumor testing—in which multiple genetic locations and other molecular markers can be simultaneously interrogated by various methods in order to provide precision treatments of cancer—has become commercially available in the last few years (Gray et al., 2014; Epelbaum et al., 2015). Molecular Intelligence (MI) is a set of molecular biomarker tests that may be ordered within a predefined profile or individually, offered as part of a tumor profiling service provided by Caris Life Sciences. It is based upon a previous test known as Target Now Molecular Profiling. MI differs from Target Now in its methodology platform, which incorporates next-generation sequencing (NGS), and in the biomarkers analyzed. According to the manufacturer, MI testing provides information based upon an extensive literature review that associates a tumor's biomarker status with standard or nonconventional therapeutic agents that have potential or lack of potential clinical benefit. The profiling also identifies open clinical trials relevant to particular biomarkers. Each component of the profile is tied to referenced published evidence regarding the relevant biomarker. Final therapeutic decisions are to be determined by the treating physician using MI as a guide. The focus of this review is to assess the evidence that supports the use of MI profiling as a decision support aid for physicians, providing them with a list of potentially actionable biomarkers to help guide treatment and improve clinical outcomes in patients with rare, advanced, or refractory solid tumor cancer. This report does not evaluate the clinical validity/utility of tumor profiling in general, and does not address the clinical trials and data supporting drug/biomarker correlations that may be used by this test.

Project Status: Completed

Year Published: 2016

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=42666

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: 2014 Winifred S. Hayes, Inc