Tuesday, November 13, 2007



FDA Week via NewsEdge Corporation :

Genetic testing advocacy organizations applaud the HHS genetic task
force's call this week for FDA and other agencies in HHS to jointly
assess direct-to-consumer advertising of genetic tests and take
enforcement action against laboratories and companies that make false
genetic test claims. The groups are also pleased the task force is
pushing HHS to expand a voluntary genetic testing registry and consider
making it mandatory after a five-year review, but a prominent consumer
group says such a registry should be mandatory immediately.

The Secretary's Advisory Committee on Genetics, Health and Society
(SACGHS) issued a slew of recommendations Monday (Nov. 5) calling for
better supervision of genetic testing to ensure the tests are accurate
and useful. The panel demurs from suggesting FDA or CMS have primary
oversight of genetic tests, an issue some genetic advocacy groups had
wanted the task force to settle.

Task force member Kathy Hudson, director of the Genetics and Public
Policy Center at Johns Hopkins University, says the panel felt both
agencies had jurisdiction.

But regulation is murky: Although FDA only regulates tests sold to other
labs, CMS administers the Clinical Laboratory Improvement Amendments
(CLIA), which assess how well tests perform.

FDA has generally ignored laboratory-developed tests but recently
stepped up oversight in the area. It issued a guidance this summer on
what tests qualify as multivariate index assays (IVDMIAs), which are a
subset of genetic tests patients use to predict whether they will
develop diseases such as cancer. FDA also issued a guidance in 2006 on
its oversight of analyte specific reagents (ASRs), which are the
building blocks used by clinical laboratories to develop LDTs. ASRs
include antibodies and proteins.

SACGHS states there is a disparity between FDA and CMS regulations and a
lack of clarity on genetic test measures. The panel recommends HHS'
agencies collaborate and with professional organizations on collecting
better data for analytical and clinical validity and developing
standards for applying genetic tests in clinical practice.

Analytical validity is the measure of a test's reliability. Clinical
validity is a test's ability to detect a disorder.

SACGHS also expresses concern about DTC ads for genetic testing. It says
consumers don't understand the ads, claims are unproven and ambiguous,
and there is a lack of trained genetic professionals to explain test
results to patients.

FDA, CMS, the Federal Trade Commission and other agencies, working with
state governments and stakeholders, need to address false or misleading
DTC ads. The agencies also need to consult with states and other
stakeholders to develop an enforcement approach for any misleading ads,
SACGHS states in the draft report.

Edward Abrahams, executive director of the Personalized Medicine
Coalition, says the group supports federal intervention in DTC ad
genetic test oversight because the public is not trained to interpret
genetic risks from tests.

SACGHS also recommends a voluntary, genetic testing database, developed
through a private-public partnership, "to cut down on the information
gap on the number and identity of labs performing tests and the tests

SACGHS recommends HHS fund the expansion of GeneTests, a voluntary
online directory of genetic tests and the labs offering them. The panel
estimates more than 1,100 genetic tests are offered in clinical labs,
based on the information submitted to GeneTests.

No federal agency maintains the site. SACGHS recommends HHS assess the
system after five years and consider making registration necessary if
data is lacking.

Paul Radensky, a lawyer representing The Coalition for 21st Century
Medicine, says a registry could boost physicians and patients'
confidence in clinical test validity. Over time, he says, payers may
look at the registry to determine coverage.

Registration seems to be a good idea, says Vince Stein at the American
Association for Clinical Chemistry. Still, AACC, a professional group
representing lab directors, wants to know whether GeneTest registration
would require test approval before a test is submitted to the database.

Peter Lurie at Public Citizen calls the recommendation and report "very

"It's a rubber stamp for the no-significant action approach the
government has been taking," he says.

SACGHS also states FDA needs to better explain the "nature and scope" of
FDA oversight of electronic systems that interpret genetic data used to
determine physician treatment.

SACGHS recommends FDA work with other agencies, working groups and
stakeholders to come up with a better regulatory framework for clinical
decision support systems. It says FDA should then prepare a guidance on
clinical decision support systems explaining which system features are
devices regulated by FDA.

SACGHS also calls on HHS to recommend additional studies to assess
clinical utility, which refers to how useful the test will be in routine
practice, and says HHS should publish results of assessments on HHS' or
another Web site.

The panel also recommends CMS make sweeping changes to its CLIA
structure to better address genetic tests. One of the panel's larger
concerns is a test measure of how well genetic tests consistently
diagnose patients correctly. CMS rejected a request by Public Citizen
and a genetics policy group earlier this year to require that
laboratories always prove the efficiency of the genetic tests they use.

SACGHS recommends HHS add more tests under CLIA that must go through the
proficiency testing process; develop incentives for proficiency testing
providers to expand their services to more genetic tests; and fund
effectiveness studies for other types of performance assessments. The
task force calls for CMS to consult or contract experts to train
inspectors of genetic testing labs; and use revenues generated by CLIA
to hire staff to enforce regulations.

SACGHS also urges CMS to cover and reimburse genetic tests and
counseling services.

SACGHS wants CMS to prevent labs from performing genetic tests without
CLIA certification. The CLIA program cannot penalize uncertified labs so
CMS must report these labs to the HHS Inspector General.

"HHS should explore mechanisms and seek or develop new authorities and
resources to enable CMS to strengthen its enforcement efforts against
laboratories that perform genetic tests for clinical purposes without
CLIA certification. CMS should step up its efforts to make publicly
available a list of laboratories that have been cited by CLIA for
condition-level deficiencies," the report states.

SACGHS also calls for CLIA's regulations or statutory authority to be
expanded to cover genetic tests that test for caffeine metabolism or
determine the gender of a fetus.

These tests are "examples of health-related genetic tests that are
skirting the boundaries of CLIA's authority," the report states.

SACGHS is scheduled to meet Nov. 19 and 20 to discuss the draft report.
Comments are due Dec. 21.

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