SaneVax criticizes FDA for approval of Roche's cobas HPV genotyping test

In an April 22, 2011 letter to FDA Commissioner; Dr. Margaret Hamburg, Norma Erickson on behalf of the SaneVax Inc. Board of Directors, criticized the FDA for not following its own guidelines and recommendations in approving Roche's cobas HPV Test for cervical cancer screening and for HPV-16 and HPV-18 genotyping.

“HPV test device shall therefore be retained in Class III, and is subject to premarket approval requirements.”

The 2009 FDA guidance for industry and FDA staff recommends new HPV test manufacturers consider analytical evaluation of the test on the most clinically relevant non-vaccine targeted HPV genotypes because the most clinically relevant HPV genotypes are expected to shift over time among HPV vaccinated individuals in the United States. An HPV test for genotyping of the vaccine-targeted HPV-16 and HPV-18 only does not meet this FDA requirement.

Furthermore, the above FDA guidance also recommends any new HPV genotyping device be validated by an FDA-approved HPV test, or by PCR plus DNA sequencing. There is no evidence that the Roche cobas HPV genotyping test has been validated by an FDA-approved genotyping method or by sequencing.

Since the Roche cobas HPV test has not been properly validated for its accuracy in genotyping and has not been evaluated for detecting the most clinically relevant non-vaccine targeted HPV genotypes, it should not be approved as a new HPV test device for commercial distribution, said Erickson.

According to one prior FDA Reclassification Order, "HPV test device shall therefore be retained in Class III, and is subject to premarket approval requirements." Approval of a class III cervical cancer screening device without an advisory committee meeting open to the public is also against the FDA's own rules, Erickson pointed out.

The SaneVax Team believes that HPV genotyping methods for safe and effective HPV vaccination practice and for post-licensure vaccine monitoring must be reliable. Therefore, they request that the approval of Roche's cobas HPV test be rescinded until the device is properly validated according to current FDA standards.