Petrelis Files

Feb. 22, 2005

David Corcoran
Science Desk
The New York Times

Dear Mr. Corcoran:

Since Feb. 12 the Times' many articles about a suspected case of a drug-resistant mutant strain of HIV in New York have reported on tests used to test the specimens of the patient with this strain. These tests are manufactured, sold and promoted by the ViroLogic company.

In all of the reporting on this case by the Times, the paper has failed to once inform readers that the drug-resistant tests have not received the blessing of federal Food and Drug Administration.

This fact can be verified by reading the four-page product guide for ViroLogic's PhenoSense GT assay, which states the following:

"This test was developed and its performance characteristics determined by ViroLogics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration." (Source: http://www.virologichiv.com/pdf/GT_Product_Guide.pdf , page 4)

The reasons for this lack of approval are contained in ViroLogic's 2002 eighty-seven-page annual report to shareholders.

It said:

"The FDA may impose medical device regulatory requirements on our tests, including possible premarket approve requirements, which could be expensive and time-consuming and could prevent us from marketing these tests.

"In the past, the FDA has not required that genotypic or phenotypic testing conducted at a clinical laboratory be subject to premarketing clearance or approval, although the FDA has stated that it believes its jurisdiction extends to tests generated in a clinical laboratory.

"We received a letter from the FDA in September 2001 that asserted such jurisdiction over in-house tests like ours, but which also stated the FDA is not currently requiring premarket approval for HIV monitoring tests such as ours provided that the promotional claims for such tests are limited to its analytical capabilities and do not mention the benefit of making treatment decisions on the basis of the test results.

"The FDA letter also asserted that our GeneSeq test had been misbranded due to the use of purchased analyte specific reagents (ASRs), if test reports do not include a statement disclosing that the test has not been cleared or approved by the FDA. We now utilize in-house prepared ASRs in our products. The FDA has indicated in discussions that the focus of the letter was our genotypic tests and not our phenotypic tests, but there is no certainty its focus will remain narrow.

"We have had several discussions with the FDA related to its position set forth in the letter. We do not at this point believe the FDA will require us to take steps that materially affect our business or financial performance, but we cannot guarantee this will remain the case.

"We cannot be sure the FDA will accept the steps we take, or that the FDA will not require us to alter our promotional claims or undertake the expensive and time consuming process of seeking premarket approval with clinical data demonstrating the sensitivity and specificity of our tests.

"If premarket approval is required, we cannot be sure that we will be able to obtain it in a timely fashion or at all; and in such an event the FDA would have authority to require us to cease marketing tests until such approval is granted.

"In general, we cannot predict the extent of future FDA regulations of our business. We might be subject in the future to greater regulation, or different regulations, that could have a material effect on our finances and operations. If we fail to comply with existing or additional FDA regulations, it could cause us to incur civil or criminal fines and penalties, increase our expenses, prevent us from increasing revenues, or hinder our ability to conduct our business." (Source: http://media.corporate-ir.net/media_files/NSD/VLGC/reports/2002_ar.pdf , pages 29 and 30)

Please answer two questions I have about the lack of FDA approval for ViroLogic's tests, the reasons behind it, and your paper's coverage of the tests and their tremendous impact on the news and public health policies.

First, why has the Times not reported on the absence of FDA approval for the tests?

Second, is the paper truly committed to reporting on all scientific aspects of the mutant HIV strain in New York, including questions about why the FDA has not condoned ViroLogic's drug-resistance assays?

I ask for a prompt response.

Regards,
Michael Petrelis
San Francisco, CA