Friday, May 6, 2011

SaneVax Inc. Protests FDA Approval of Second-Rate HPV Genotyping as a Cancer Test

Last week the FDA approved the HPV cobas test manufactured by Roche for HPV-16 and HPV-18 genotyping utilizing a probe-based technology for cervical cancer screening in the United States.


PRLog (Press Release) – May 04, 2011 – This test was approved without a public advisory committee meeting, despite FDA regulations requiring such a meeting prior to the approval of any cancer diagnostic test.

Granting approval behind closed doors has denied American medical consumers’ access to any safety and/or efficacy data submitted to the FDA prior to their approval of this Class III ‘cancer screening’ test, contrary to prior FDA actions and current published guidelines.

According to one prior FDA Reclassification Order, “HPV test device shall therefore be retained in Class III, and is subject to premarket approval requirements.” (This includes at least one pre-approval advisory committee meeting open to the public.) The same FDA order also ruled, “…probe design is a critical process for HPV DNA testing because of the large number of closely related HPV genotypes. Complex probe cocktails may cross-react and/or compete with one another….”

A separate FDA Staff and Industry Guidance Document clearly states the FDA recommends any new HPV genotyping device be validated by an FDA-approved HPV test, or by PCR plus sequencing.

Both the National Cancer Institute and current scientific textbooks refer to DNA sequencing as the reliable method, or the ‘gold standard’ for HPV genotyping.

Based on research the SaneVax Team discovered in the public domain, approval of the HPV-16 and HPV-18 genotyping method used in Roche’s cobas device was not granted in accordance with the FDA’s own recommended protocol, or currently accepted scientific standards. This has made it virtually impossible to determine the validity/accuracy of Roche’s test.

The SaneVax Team received no response to their April 22, 2011 letter to FDA Commissioner, Dr. Margaret Hamburg, which emphasized one additional problem with the new ‘cancer screening test’ manufactured by Roche:

“The positive predictive value (ppv) of this cancer test for CIN3 (8.4%) was reported to be lower than the ppv for CIN2 lesions (14.0%). We all know a CIN3 lesion is more cancer-like than a CIN2 lesion. It is highly disturbing to learn that a ‘cancer test’ approved by the FDA appears to lose its positive predictive value as a precancerous lesion progresses to a more severe stage close to cancer.”

It appears the FDA has left medical consumers depending on a test that has not been proven accurate (validated), has not cross-checked results by using DNA sequencing, and exhibits accuracy (ppv) that diminishes as abnormal cervical lesions come closer to developing into cancer.

Should this ‘cancer test’ be marketed as a means to monitor HPV vaccinations, it will do nothing to prove HPV vaccine safety, efficacy or need.

Therefore, the SaneVax Team again requests the approval of Roche’s cobas HPV test be rescinded until the device is properly validated according to current FDA standards.


1. View Roche's press release - ...

2. View Re-classification order - ...

3. View Guidance for Industry and FDA Staff - ...

4. View NCI HPV testing information -

5. View textbook information on HPV testing -

6. Read letter to FDA Commissioner -

# # #

SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

No comments:

Post a Comment