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FDA Grants Marketing Approval to Gen-Probe

The Food and Drug Administration granted marketing approval to Gen-Probe, Inc. recently for the nation’s first approved blood test for West Nile virus.

The San Diego-based company, best known for tests for hepatitis C and HIV, rose to the FDA’s challenge in 2002 to begin developing such a test. The urgency extended from the discovery that the virus could be transmitted through donated blood.

Gen-Probe developed the test known as Procleix WNV with San Francisco Bay Area’s Chiron, Inc. Gen-Probe’s stock, traded on the Nasdaq stock exchange under the symbol GPRO, rose $3.01, or 6 percent the day after the approval to close at $49.18 on Dec. 2, but dropped slightly to level off at $47.60 by the close of market Dec. 6.

While Procleix WNV was being tested at blood centers across the nation, Gen-Probe said the test intercepted about 1,500 units of blood infected with West Nile virus, preventing as many as 4,500 people from receiving contaminated blood.

In the United States this year, 2,775 cases of West Nile virus have been reported this year, according to the federal Centers for Disease Control and Prevention. There have been 854 cases reported in California this year , one in San Diego County.

Gen-Probe, which has 900 employees and was founded in 1983, reported net income of $54.6 million in 2004.

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Avanir Posts Results:

San Diego’s Avanir Pharmaceuticals reported a net loss of $30.6 million, or 30 cents per share, for the year ended Sept. 30 compared with $28.2 million, or 36 cents per share for its 2004 fiscal year.

The company markets Abreva, a cold sore medication, and has submitted an application to the Food and Drug Administration for Neurodex, a drug that would be used to treat pseudobulbar affect, or uncontrollable laughter and crying in people with neurological disorders.

Revenues increased to $16.7 million for the year compared with $3.6 million in fiscal 2004. The jump is due primarily to licensed technology and research and development services that Avanir provides to drug companies, including London-based AstraZeneca and Basel, Switzerland-based Novartis, the company reported.

Avanir had about $27.5 million in cash and equivalents compared with $25.9 million at last year’s end. Avanir stock trades under the symbol AVN on the American Stock Exchange.

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Naviscan Gets $6.5 Million:

Naviscan Pet Systems, Inc., which makes positron emission tomography scanners, has relocated its headquarters to San Diego and recently attracted $6.5 million in investment from venture capitalists.

The private company’s scanners are used to image small body parts to guide difficult surgical and radiological procedures. Naviscan said it will use the money from venture capitalists to pay for testing the scanners, which might also have the capability of detecting cancer tumors while still in early stages. The series B financing round was led by Sanderling Ventures, which has offices in San Diego and San Mateo. Rochester, Minn.-based Mayo Medical Ventures also participated.

Naviscan announced Nov. 28 its plans to move from Rockville, Md., to the Sorrento Valley area.

Chief Executive Officer Paul Grayson said the company, founded in 1995, relocated to take advantage of the high-tech work force in San Diego.

Contact Katie Weeks with biotechnology news at kweeks@sdbj.com, or call her at (858) 277-6359.


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