In fact, such tests are in place and used routinely in many of our laboratories today. These molecular tests are an extension of the current diagnostic armamentarium. They can be thought of as tools that detect disease earlier than conventional screening tests such as mammograms. The benefits of early detection are prediction of risk for development of disease, early intervention, monitoring and targeting of therapy. For example, leukemias carry unique, somatic genetic markers which serve not only to help diagnose the disease but to monitor recurrence after treatment.
Cancer treatment is generally far more successful before the cancerous cells massively reaccumulate.
A major question has been posed by the Subcommittee regarding quality assurance of genetic testing as a safeguard against incorrect results of genetic testing. As practitioners of laboratory diagnostics, pathologists have a deep and primary concern for ensuring the quality of laboratory tests, including genetic tests. By working together with federal regulatory agencies, pathologists and other laboratory physicians have constructed a very effective system to accredit laboratories, certify physicians and approve test materials. The accreditation of the accuracy of genetic testing can be assured through the existing program by extension of the regulations to genetic tests. In fact, this process is already underway.