Published on July 22, 2010
Contact: Jodi Greenblatt
CAP Urges Increased Oversight of Direct-to-Consumer Laboratory Tests Citing Potential Risk to Patients
Washington, DC—With the increasing importance of laboratory tests in diagnosing and treating disease, the College of American Pathologists (CAP) today sent a letter to Rep. Bart Stupak (D-MI), Chairman of the House Oversight and Investigations Subcommittee, urging increased oversight of “direct-to-consumer” DTC tests.
“CAP believes that direct-to-consumer testing is clinical laboratory testing and should be subject to appropriate safeguards for health related conditions,” said John Scott, the CAP’s Vice President of Advocacy.
“While direct-to-consumer testing has the potential to empower patients in the management of their own health, it is no different than testing ordered by a licensed provider in that it poses a number of risks to the patient and public safety. Since genetic testing seeks to fully detail an individual’s unique DNA or molecular composition, it can generate a multitude of diagnostic or prognostic information, which is often complex and requires expertise for proper interpretation and clinical application.”
DTC tests have recently come under scrutiny as several companies are selling non-FDA approved genetic test kits over the Internet, and some are poised to sell unapproved genetic test kits to consumers through national pharmacy chains. Many DTC genetic test kit manufacturers contend the tests do not fall under FDA regulation.
“Treating direct-to-consumer testing as clinical laboratory testing would ensure that this aspect of laboratory testing meets appropriate quality controls required under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)”, the letter stated.
The CAP believes such direct-to-consumer tests should be viewed as moderate or high complexity tests, as defined by CLIA, unless they rely solely on kits classified as “waived” by the Food and Drug Administration (FDA) and used in accordance with the kit manufacturer’s instructions.
CLIA requirements for oversight of moderate and highly complex laboratories require provision of a qualified laboratory director and clinical consultant. In the case of direct-to-consumer testing, CAP believes consumers should have access to a clinical consultant provided by the laboratory producing the direct-to-consumer testing products.
At a hearing sponsored by the Food and Drug Administration earlier this week, Gail Habegger Vance, MD, professor of Medical and Molecular Genetics at the Indiana University School of Medicine (IUSM) in Indianapolis and a member of the CAP Board of Governors, also raised concerns about quality control of DTC tests, stating “when a clinical test is performed outside a lab there is no way to ensure the competency of the testing personnel, the accuracy of software and document controls of the processing laboratory, or any other good laboratory practices required to produce accurate results.”
CAP believes that companies offering third party interpretive services to consumers for clinical testing should be considered a clinical laboratory, whether or not that organization receives or processes physical specimens, and manufacturers or marketers providing interpretive services to consumers should be subject to appropriate regulation.
CAP’s letter included the following recommendations regarding oversight of DTC tests:
- DTC tests should be regarded by state or federal authorities as clinical laboratory testing and required to meet all applicable requirements as defined by CLIA.
- The laboratory should provide consumers access to a clinical consultant.
- Better enforcement of laws or regulations is needed to protect consumers against deceptive or unscrupulous marketing or promotion of DTC testing.
- Companies offering third party interpretive services to consumers for clinical testing should be considered a clinical laboratory, whether or not that organization receives or processes physical specimens.
- Individual DTC test results should be considered health information subject to the protections of the Health Insurance Portability and Accountability Act (HIPAA) and relevant state privacy laws.
Patients deserve to be gatekeepers of their health information, but they also may need a medical professional to interpret the test results and recommend next steps, “DTC testing is clinical laboratory testing and should be subject to appropriate safeguards,” the letter stated.
Today’s pathologists are at the forefront of advancing new methods of molecular analysis that provide for better management of a patient’s disease or predisposition towards disease. This includes tests to more precisely diagnose subsets of diseases and the selection of therapies best suited to patients with specific genetic characteristics.
The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of board certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care.