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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

August 27, 2009

August 27, 2009

Our STN:   BL 125255/7                                      

Roche Molecular Systems, Inc.
Attention:  Carol A. Pachl, Ph.D.
4300 Hacienda Drive
Pleasanton, CA  94566-0900
Dear Dr. Pachl:

We have approved your request to supplement your biologics license application for your cobas TaqScreen MPX Test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA, to include testing for HIV-1 Group O and Group M RNA , HIV-2 RNA, HCV RNA, and HBV DNA in post mortem cadaveric (non-heart beating) donors using an individual testing format.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

All promotional claims must be consistent with and not contrary to approved labeling.  You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

 

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and
  Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research