Biotech Tracker News - Study Highlights the Barriers to the Use of Genetic Susceptibility Testing
March 12, 2003 Myriad Genetics (NASDAQ: MYGN) is the leader in the development of genetic susceptibility tests. Its tests for susceptibility to heritable cancers have been validated by several detailed scientific studies, but consumer acceptance of these tests is slowed due to fears of insurance carrier discrimination as well as psychological and psychosocial issues. Fourth quarter 2002 sales of Myriad’s genetic tests yielded only about $8.2 million in revenue.  A new publication analyzes how factors such as insurance discrimination and patients’ attitudes impact use of hereditary nonpolyposis colorectal cancer (HNPCC) susceptibility testing, marketed by Myriad as Colaris. These concerns suggest a long road toward routine acceptance of gene-based susceptibility testing. Until these barriers are addressed, each new test will face a significant degree of resistance. The current investigation assessed attitudes, intentions, and uptake of genetic testing within newly identified families with HNPCC.  Hadley, Kirsch et al published Genetic Counseling and Testing in Families With Hereditary Nonpolyposis Colorectal Cancer in the March 10, 2003 issue of Archives of Internal Medicine. The researchers conducted a cohort study at the National Institutes of Health between April 15, 1996, and November 20, 1999, in which data were obtained through questionnaires before HNPCC-related education sessions, individual counseling sessions, and the offer of genetic testing.  Of 111 evaluable first-degree relatives of CRC-affected individuals in whom a suspicion for a familial susceptibility mutation existed, 51% chose to participate in education and counseling sessions. The likelihood that a first-degree relative would participate in genetic risk assessment increased with greater numbers of first-degree relatives with cancer. Participation did not increase with a personal history of cancer. Prior to education and counseling sessions, several notable factors prevailed:  64% had heard little about genetic testing for cancers  97% stated intentions to pursue testing  72% believed they very likely or definitely were carriers of an HNPCC mutation  51% indicated that learning about their children’s risks was the most important reason to consider testing  17% were most interested in guiding decisions regarding cancer screening and surveillance  some younger study subjects were interested in guiding their reproductive decision making 39% indicated the potential effect on their health insurance as the most important reason to not undergo testing  51% eventually chose to undergo genetic testing.  The concerns of the 39% who worried that they themselves or family members could lose health insurance are typical, despite researchers and practitioners discussing the relevant state and federal laws addressing genetic discrimination and the paucity of genetic discrimination cases reported to date. Moreover, participants tend to worry, as they did in this trial, about their own reaction to test results and the effects the knowledge would have on family members. Whether the impact of choosing to undergo testing was optimal in terms of Colaris-associated morbidity and mortality reduction remains to be seen, and is certain to be evaluated in future study. Given specific comparative clinical and epidemiological factors, Colaris should have at least the impact of BRACAnalysis on the successful management of cancer and cancer susceptibility.  HNPCC, also known as the Lynch syndrome, is the most common hereditary form of colorectal cancer, accounting for approximately 1-5% of individuals who develop colon cancer. Approximately 380,000 individuals in the U.S. carry an HNPCC susceptibility mutation and have a greater than 90% lifetime risk of developing at least one of the following cancers: colon, rectum, uterus, small intestine, stomach, urinary tract, kidney, ovary, brain, and certain other (more rare) sites.
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