Kennedy
Targets Home Brew Tests by Introducing Laboratory Test Improvement
Act
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 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:
A
PDF of the proposed Laboratory
Test Improvement Act is available at DarkDaily.com.
Analysis
of Senator Kennedy's sponsorship of the Laboratory Test Improvement
Act
Senator
Kennedy Press Release on Genetic Laboratory Tests
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