Therefore, they should not be regulated in a manner that is different from other medical tests. Ensuring that organizations carrying out a medical test are doing so in an accurate and responsible fashion is within the purview of government institutions, but such oversight should be exercised on all medical tests, independent of the technology used to arrive at the result. Rather than creating a new regulatory structure, therefore, it is essential to make sure the current system keeps up with scientific advancement. Consequently, BIO s view is that appropriate oversight is already provided by the current CLIA system. The CLIA system has successfully promoted quality in laboratory tests for many years and we are confident it can continue to do so.
Genomics is a developing science.
As our knowledge this field increases, the utility of genetic tests will change. The scope of genetic testing will not only be predisposition to disease but also knowledge about the body s metabolism and other general conditions. We need an oversight system that is flexible enough to adapt to technological developments. These technologies will provide patients with new types of beneficial information about their health and the most appropriate therapeutic to maintaining their health. Moreover, singling out genetic tests for separate and increased regulation could hurt the development of new technologies that hold great promise for patients.