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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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June 4, 2004 Approval Letter - Procleix HIV-1/HCV Assay

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

June 4, 2004

Our STN Number: BL 103966 / 5021

ATTN: Leanne M. Kiviharju
Gen-Probe, Incorporated
10210 Genetic Center Drive
San Diego, California 92121-1589

Dear Ms. Kiviharju:

Your request to supplement your Biologics License Application (BLA) for Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) to allow for an expanded intended use claim to include testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing, has been approved.

Your request for additional indications for testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors) has also been approved.

This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.

Sincerely yours,

--- signature ---

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