Since the completion of the Human Genome Project in 2003, scientists, physicians, policy makers and consumers have eagerly anticipated the era of personalized medicine with targeted preventive care and therapeutic treatment based on an individual’s genetic makeup. Today, billions of dollars are being invested in research and development in order to advance our knowledge of genetic information that helps people make more informed medical decisions in conjunction with other factors including family history, lifestyle and environment. Genetic results do not replace or override these factors, but should be considered in combination with them to provide a more complete risk profile.

Pathway Genomics wants patients, FDA and Congress to know that safety, security, privacy and the delivery of accurate and practical information continue to be our top priorities.

While the recent Government Accountability Office (GAO) report did identify serious and legitimate concerns about the practices of some genetic testing companies, we feel that it is unfair to associate the scientific leaders of this emerging industry with what the GAO referred to as “bottom feeders” who are exploiting people’s misunderstanding of genetic tests. We agree, these types of practices should not be tolerated, and have no place within the scientific and medical community.

Further, the GAO report recommends that FDA develop consistent standards for this developing science, a position Pathway wholeheartedly agrees with and supports. It is noteworthy that the GAO report does not refute the validity of the scientific data of each company’s results, only the interpretation of the data. Pathway believes that the industry would greatly benefit from a standardized method of interpreting a person’s genetic test results. We anticipate working with FDA and other regulatory agencies in the establishment of these standards.

Licensed physicians can order personal genetic reports from Pathway’s federally CLIA-certified and California state-licensed laboratory. Furthermore, Pathway’s on-staff medical doctors and genetic counselors review all orders and results before information is released to individuals. To further support physicians and their patients, genetic counseling is available, at no extra charge, before, during and after testing. Our genetic counseling service is staffed by qualified counselors who are Board-eligible or -certified by the American Board of Genetic Counseling. All of our genetic counselors are under the supervision of our on-staff medical doctors.