Their petition is addressed to Mark McClellan, the outgoing administrator of the Centers for Medicare and Medicaid Services (CMS).

"Regulations are necessary to ensure the accuracy and reliability of genetic testing," Gail Javitt, a policy analyst at the Genetics and Public Policy Center, said at a news conference at the National Press Club in Washington.

The CMS has the authority to regulate genetic testing through a 1988 act that oversees specialties of clinical testing.

While genetic testing is undoubtedly a highly complex type of clinical testing, the CMS has not yet established a specialty area for most types of genetic tests.

The absence of a specialty area has meant that no proficiency testing is required for any laboratories performing genetic testing, the consortium petition points out.

The consortium wants the CMS to classify genetic testing into a specialty area so that mandatory and regulated proficiency tests can be established for all types of genetic testing.

Questions about the oversight of genetic testing have grown as genetic tests have been increasingly used for diagnostic purposes. Genetic tests did not exist until the late 1970s, but with the recent completion of the Human Genome Project and scientific advances, genetic tests are now used to diagnose and predict the development of more than 900 diseases.

Technological advances have made it possible for genetic tests to become a commercial venture. Although many of the laboratories that perform genetic tests are of a very high quality, the consortium argues that regulations are needed in order to standardize the quality of tests administered by all labs.

DNA Direct, a San Francisco-based genetic testing company, mails test kits to its customers, and the customers then send back a cheek swab or a stool sample for analysis. While DNA Direct provides its customers with the information necessary to understand the complex results of their genetic test, the actual laboratory analysis is conducted in the laboratories of LabCorp.

Ryan Phelan, founder and chief executive officer of DNA Direct, told UPI the national labs are already operating under the standards the consortium would require.

"The smaller labs are the ones which will be challenged to a higher standard of testing. Regulations may help increase the quality of testing at smaller independent labs, but the majority of testing in the country is being done by nationally referenced labs that are already at a very high standard," Phelan said.

Although Phelan doesn't believe that strengthening regulation will impact her company, she is wary of regulation because of its market-distorting potential.

"For nationally referenced labs, regulations and standardization will reduce competition. ... Regulations can adversely impact the quality of care available to consumers down the road, because competition is a good thing," she said.

Kathy Hudson, director of the Genetics and Public Policy Center, disagrees with Phelan and maintains that increased regulation is necessary even for the large national labs.

Hudson told UPI that recent surveys conducted by the Genetics and Public Policy Center indicate that 44 percent of the large labs surveyed are not conducting proficiency testing on some or all of their samples. This finding is important because there is a clear and direct correlation between participating in proficiency testing and test quality, she said.

While Hudson admits many national labs are "going the extra mile" to ensure that their test results are accurate and reliable, she says stronger regulation is needed to provide consumers with accurate and reliable information about the quality of tests administered by all companies.

"It is impossible for consumers to distinguish between a quality lab and a substandard lab because information about performance on proficiency testing is not publicly available," she said.

Receiving inaccurate test results can have devastating consequences, such as misdiagnosing diseases. The consortium's petition points out that even with stringent standards, some errors will occur. The potentially tragic consequences of inaccurate genetic test results suggest ensuring accuracy should be the foremost priority.

Despite their different perspectives on the issue of genetic-testing regulations, there is one thing that both Phelan and Hudson can agree on: "Getting patients the highest quality of tests is in our interest and everyone's interests," Phelan said.

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