Biomira Diagnostics Inc.'s blood test for detecting recurrent breastcancer was cleared for marketing Monday by the FDA.

The Truquant BR Radioimmunoassay detects the CA27.29 antigen, amucinous glycoprotein product of the MUC-1 gene, which is presentin cancer cells. The glycoprotein is shed into the bloodstream asbreast cancer spreads.

Truquant BR already is being sold in Canada and Europe, and hasbeen available for research use in the U.S. The approval is expectedto expand the U.S. laboratory market to $10 million from $6 million,said Tim White, product manager, oncology, for BiomiraDiagnostics, a Toronto-based wholly owned subsidiary of BiomiraInc., of Edmonton, Alberta.

"This is a significant milestone in the [12-year] history of BiomiraDiagnostics," White said. "It's very big news for this company. Weregetting a large number of requests for information about the product."

The test specifically was approved to detect recurrence in womenpreviously treated for Stage II and III disease, which represent tumorsthat have spread to nearby nodes. More than 1 million women in theU.S. have been diagnosed with those stages of disease.

White said Biomira is preparing additional claims that would allowuse with Stage IV disease, indicating spread to a distant organ.

The test, Biomira said, detects recurrence of breast cancer on averagefive months earlier than existing methods. Early detection can lead toearlier treatment.

Polymedco Inc., of Corltandt, N.Y., is exclusive distributor ofTruquant BR. Immunex Corp., of Seattle, is co-marketing the productwith Biomira. Immunex will target oncologists with its sales force,which already is in place, and will help in getting reimbursementfrom insurers. The test is expected to cost $50.

A study involving 166 breast cancer patients who were free ofdisease at enrollment found a positive Truquant test meant the cancerrecurred 99 percent of the time. n

-- Jim Shrine

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