CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News UpdateUNITED STATES: FDA to Scrutinize HPV Test Linked to False Readings
By Bob Ortega
August 2, 2013
USA Today (07.31.2013)
The US Food and Drug Administration (FDA) issued a warning more than six months ago that BD SurePath test kits used to screen women for human papillomavirus (HPV) could give incorrect false-negative results. However, laboratories continued to use the BD SurePath test, prompting a dispute between FDA and the American Clinical Laboratory Association (ACLA).
Becton Dickinson and Co. originally developed the BD SurePath kit for Pap testing; laboratory use of the kit for HPV testing was not FDA-approved. Laboratories used SurePath for approximately 3 million Pap/HPV tests annually, despite national cervical cancer screening guidelines that specified use of FDA-approved tests for HPV screening.
ACLA argued that FDA had no jurisdiction under federal law because the SurePath test was not a medical device. Current law specifies that a laboratory can develop clinical tests or use existing tests for non-FDA-approved purposes, if the laboratory conducted studies to establish the “test’s accuracy and sensitivity.” At present, the Centers for Medicare and Medicaid Services (CMS) exercises oversight of lab-developed tests under the Clinical Laboratory Improvement Amendment (CLIA). Developers can outsource review of laboratory-developed tests to auditors, such as the College of American Pathologists, but are not required to provide results of validation studies to CMS.
Because of concerns about SurePath and other laboratory-developed tests, FDA has submitted new draft guidance to the Obama Administration. The College of American Pathologists agreed with the FDA proposal to regulate “high-risk laboratory-developed tests” and recommended that CLIA regulations continue to govern the development of “low- and moderate-risk laboratory-developed tests.”