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Gen-Probe to Test Blood for West Nile

Posted on: Friday, 2 December 2005, 09:00 CST

By Penni Crabtree, The San Diego Union-Tribune

Dec. 2--Diagnostics developer Gen-Probe yesterday won regulatory approval for the nation's first test to screen donor blood for the potentially deadly West Nile virus.

Since 2002, when it was discovered that West Nile could be transmitted in donated blood, government health officials, blood banks and select diagnostics companies have been working to devise a test to protect patients who get blood transfusions from contracting the disease.

Gen-Probe, a San Diego biotechnology company best known for HIV and Hepatitis C screening tests that are widely used to safeguard the nation's blood supply, devised its West Nile test in 2003.

U.S. blood centers have been using the test, dubbed Procleix WNV, on an experimental basis and have screened more than 29 million units of donated blood. The testing has intercepted about 1,500 West Nile-infected units, preventing transfusion of contaminated blood into as many as 4,500 people, according to Gen-Probe.

"This approval is the result of a tremendous cooperative effort among FDA, other public health agencies, the test kit manufacturers and the blood industry," said Dr. Jesse Goodman, director of Food and Drug Administration's Center for Biologics Evaluation and Research. "To develop an investigational test to screen blood, tissue and organ donors, and to get this test in blood banks throughout the country, and then licensed this quickly is a remarkable achievement for public health and patient safety."

Shares of Gen-Probe rose $3.01, or 6 percent, to close at $49.18.

There have been 2,744 cases of West Nile virus disease reported in the United States this year, 98 of them fatal. In California, 847 people have contracted the virus since January, and 18 have died.

Since 2002, the virus has led to 762 deaths and about 20,000 diagnosed patients, according to the FDA. There have been about 30 documented cases linked to donated blood, the agency said.

The virus is transmitted to humans through the bite of a mosquito that has fed on infected birds. Most people who get the virus suffer mild, flulike symptoms, but in some instances it can cause deadly brain inflammation.

Gen-Probe will market the test, which detects the viruses' genetic material at the earliest stages of infection, with Emeryville-based Chiron Corp. While Gen-Probe will be the first to market with the test, rival Roche Diagnostics is testing a similar product. Roche did not return telephone calls.

"FDA approval of our West Nile virus assay represents another significant milestone in our efforts to help safeguard the U.S. blood supply," said Henry Nordhoff, chief executive officer of Gen-Probe. "The entire development program for this highly accurate assay, which began only three years ago, has been a tremendous success story for Gen-Probe."

The West Nile test has been provided to U.S. blood centers at cost while it was being tested on an experimental basis. With the FDA approval, the price will almost double, allowing Gen-Probe to make a profit on the test, Nordhoff said.

"It should be important to our revenue and net income," said Nordhoff.

Last month, President Bush named Gen-Probe a 2004 National Medal of Technology Laureate in recognition of its work in developing tests to screen the U.S. blood supply. It is the nation's highest honor for technological innovation.

Gen-Probe, which employs 900, last year reported net income of $84 million on revenue of $270 million.

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Copyright (c) 2005, The San Diego Union-Tribune

Distributed by Knight Ridder/Tribune Business News.

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GPRO, CHIR,

Source: The San Diego Union-Tribune

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