Trade News

Pleasanton, CA, April 14, 1999

FDA Grants Approval of Roche IND for HCV Blood Screening Using PCR Technology

An extra layer of safety for the nation’s blood supply is one step closer with the U.S. Food and Drug Administration’s (FDA) approval of an Investigational New Drug (IND) application by Roche Molecular Systems, Inc. (RMS).

With its first product developed specifically for the blood screening market, the IND application for the COBAS AmpliScreen HCV Test, Version 2.0, RMS can now begin its clinical trial with America’s Blood Centers (ABC), the national network of independent community blood centers that
collects
about one-half of the U.S. blood supply.

Twelve of ABC’s member laboratories are participating in a clinical trial using RMS’ new PCR test which will evaluate the performance of PCR technology and demonstrate the effectiveness of nucleic acid testing (NAT) in blood donations.

"Public demand for a virtually 100 percent safe blood supply has driven the need for a fast, accurate testing technology," said Dr. Martin Madaus, Vice President Business Development for RMS’ blood screening program.

Currently, a "window period" exists between the time a blood donor contracts an infectious disease, such as hepatitis C (HCV), and its detection by standard serological tests. Because of the unique ability of the polymerase chain reaction (PCR) technology to detect infinitesimally small numbers of viral particles in biological specimens, and the proven reliability over the recent years of Roche’s AMPLICOR and COBAS AMPLICOR PCR diagnostic testing systems, this nucleic acid-based technology is expected to substantially improve the safety for the nation’s blood supply.

In 1994, former FDA Commissioner Dr. David Kessler charged blood banking organizations, such as ABC, to implement NAT to "shut the window" during which viruses were undetectable by currently used tests. The project is wholly supported by the current FDA administration.

"Today, blood screening for virus agents in blood transfusions depends entirely on tests that detect antibodies in an infected donor, leaving a 20- to 80-day period after a person is infected," Dr. Madaus continued.

According to the Centers for Disease Control, the risk of contracting an infectious disease today from a blood transfusion is very small, one in a million units of blood for HIV and one in 100,000 for HCV. Health experts predict NAT testing will prevent an estimated 84 cases, the vast majority, of hepatitis C transmission through blood.

"NAT is the most powerful testing technology available and holds the promise of allowing blood banking organizations to virtually prevent transmission of any known virus," said Jim MacPherson, Executive Director, America’s Blood Centers. "We are all potential patients, and as one, I am thrilled at the unparalleled safety that NAT testing promises to deliver," he added.

About Roche and its PCR Products
Roche’s Version 2.0 AMPLICOR HCV Test and Version 2.0 AMPLICOR HCV MONITOR Test (a Test for the accurate quantitation of a patient’s HCV viral load) are used in research studies by many institutions in the United States and are commercially available in Europe. In the U.S., Roche began initial filing of a marketing application with the FDA of its AMPLICOR HCV Version 2.0 Test in November 1998. Test kits for both products are provided in a microwell plate format and can also be used on the COBAS AMPLICOR analyzer, Roche’s automated bench-top analyzer for PCR-ready specimens.

The Roche Group is a world leader in research-based healthcare with principal businesses in pharmaceuticals, diagnostics, vitamins, fragrances and flavors. Through the company’s Diagnostics Division, innovative testing products and services are available to physicians, patients, hospitals and laboratories worldwide. The Diagnostics Division is composed of four business units: Roche Molecular Biochemicals, Roche Molecular Systems, Roche Laboratory Systems and Roche Patient Care. Roche Molecular Systems, Inc. is responsible for the research, development, manufacture and marketing of PCR-based products under the trade name AMPLICOR .

About America’s Blood Centers
America’s Blood Centers (ABC) is a national network of non-profit, independent community blood centers that provide almost half (47%) of the U.S. blood supply. ABC members serve about 125 million people in 45 states at more than 450 blood donation- sites. ABC members also provide more diagnostic and therapeutic services than any other U.S. blood organization. For more information, contact our Website.