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FDA Finalizes HPV Diagnostic Study Guidance

Posted 14 September 2017 | By Michael Mezher 

FDA Finalizes HPV Diagnostic Study Guidance

The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer.


HPV is the leading cause of cervical cancer, with fourteen genotypes of the virus considered to be carcinogenic or high-risk. According to the Centers for Disease Control, cervical cancer was the leading cause of cancer-related death for women in the US, but thanks to widespread screening, rates of the disease have dropped significantly over the last several decades.

Earlier this week, the US Preventative Services Task Force (USPSTF) updated its recommendations for cervical cancer screening to acknowledge testing for high-risk HPV every five years as an alternative to pap tests for women ages 30 to 65.

Notably, the USPSTF's recommendations go beyond those of other groups, such as the American College of Obstetricians and Gynecologists (ACOG), whose guidelines say that HPV screening should be done in combination with a pap test.

To date only one diagnostic, Roche's Cobas HPV Test, has been approved by FDA for first-line cervical cancer screening without a pap test. Other diagnostics, like Hologic's Cervista HPV, have been approved, but only when used alongside or as a follow up to a pap test.


The newly finalized guidance provides recommendations for the studies needed to support the approval of both standalone HPV tests and ones used in conjunction with pap tests.

In particular, FDA says sponsors should conduct analytical studies to test the diagnostic's performance with regard to its limit of detection, precision, cross-reactivity and interference from other substances. FDA says sponsors should study the storage and shipping conditions for specimens and reagents used with the test.

The guidance also lays out a number of considerations for conducting clinical performance testing.

FDA encourages sponsors developing such tests to contact the agency before beginning their studies to discuss their proposals and performance goals.

"Because cervical cancer screening is recommended for virtually all sexually active women and a substantial number of these women will be tested for HPV, the risk scale for potential harm to public health from false negative or false positive results is significant," FDA writes.

Those risks, FDA says, include delayed or unnecessarily aggressive treatment that could potentially result in infertility, worsening disease or death.


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