Senators Edward M. Kennedy (D-MA) and Gordon H. Smith (R-OR) yesterday introduced a bill in the Senate that aims squarely to control laboratory-developed tests, also known as ‘home brew” tests. The trigger for this bill is the growing role of genetic technology in laboratory testing. Also, the appearance of Web sites purporting to sell genetic tests directly to consumers has created a concern in some quarters that regulation of laboratory tests can help keep scam artists and bad science out of the marketplace.

First and foremost, the bill, S.736, would require all laboratory-developed tests to be labeled with their intended use, along with a statement if the test has not been approved under this new Laboratory Test Improvement Act [Jude – Publish the PDF of the Bill on DarkDaily.com somewhere and link to it!] for such intended use. Should this bill pass, laboratories would be required to comply within 60 days of the bill becoming law.

Labeling laboratory-developed tests is just one part of this bill. It also mandates creation of a public database of information on validity of laboratory-developed tests. This database will contain explicit details on the intended use of all laboratory-developed tests that are not yet cleared by the Laboratory Test Improvement Act. This database would be maintained by the Secretary of the Food and Drug Administration, and would be available to and searchable by the public on the FDA website. Submission of laboratory-developed test data to the database would be required within one year of the bill passing.

The act also lays out three specific classes of laboratory-developed tests. Class III laboratory-developed tests are tests that are intended for use in the diagnosis of a contagious disease or condition that is highly likely to result in a fatal outcome. It is expected that special provisions will be made to allow these tests to get through the more quickly get through the verification process defined in the Laboratory Test Improvement Act.

How will this bill directly affect labs that produce their own laboratory-developed tests? More red tape…along with more development costs because of the need to properly document all tests and filter the information to federal regulators with appropriate forms. Does this bill amount to better quality of care for patients, as intended by Senators Kennedy and Smith? It certainly aims to make it blatantly obvious as to how each laboratory-developed test is to be used. It also gives the public access to information about which specific tests have or have not passed this Act.

In the long run, enactment of this proposed legislation is likely to impede the ability of legitimate clinical laboratories to develop and offer useful tests to clinicians. After all, many laws do little to deter scamsters and con artists. They continue to rip off consumers by appearing in the nooks and crannies of the system and avoiding law enforcement. It is accredited laboratories, with ongoing compliance programs, that will be forced to endure the burdens of meeting the law’s requirements. Dark Daily also observes that the uncertainty over the consequences of genetic testing is a factor in motivating elected officials to “take action” to protect the public. So the laboratory industry is also likely to see other bills designed to control the genetic genie before it gets out of the lamp.

Related Items:

Analysis of Senator Kennedy’s sponsorship of the Laboratory Test Improvement Act

Senator Kennedy Press Release on Genetic Laboratory Tests