By Mary Welch

Vysis Inc. submitted a pre-market approval application with the FDA for its PathVysion HER-2 DNA Probe Kit, which detects and quantifies HER-2 genes in breast cancer patients. The Downers Grove, Ill., company filed for an expedited review of its application under new FDA guidelines.

"There are four guidelines to qualify for an expedited review," said Russ Enns, vice president of regulatory affairs. "You only have to meet one criteria. We think we meet all four, and we definitely meet three out of the four."

Without the expedited status, the company should hear from the FDA within 180 days on its application. The FDA has 45 days to rule on its request for a speedy review. "If we are granted the expedited status, it just means that our application goes to the top of the pile," Enns said.

Realistically, the company, which reported first-quarter 1998 revenues of $5.1 million and 1997 year-end revenues of $18.2 million, expects the diagnostic test to be on the market in the first half of next year. "It's possible it could be by the end of this year or very early next year," said John Bishop, president and CEO. "But we're planning for the first half of 1999 and for the end of this year in Europe."

The test should cost a laboratory between $85 to $100. Vysis will market the product worldwide, except in Japan where it has a partnership with Fujisawa Pharmaceutical Co. Ltd., of Osaka. Vysis will file for approval in France within the next two weeks and expects a response within the next three to four months.

Each year 178,000 women in the U.S. and a similar number in Europe are diagnosed with breast cancer. In addition more than 3 million women in the U.S. and Europe are living with breast cancer.

Bishop said all patients should have the PathVysion kit analyze their biopsies. "That is our market," he said.

"We like to say that this test is the first major example of genomic disease management," said Bishop. "We are directly detecting an individual's gene configuration. Normally, one HER-2 gene clings to each chromosome 17. About 30 percent of breast cancer victims have more than one HER-2 gene on the chromosome, leading to a more severe diagnosis. The presence of multiple copies of the HER-2 gene and the overexpression of its protein are becoming a key therapeutic and prognostic marker in breast cancer."

The PathVysion kit, which can identify the multiple copies of the gene, thus serves as a guide for doctors to select therapy. "We can tell if the prognosis is worse than first expected and what the response might be to different therapies," said Bishop. "In other words, this helps doctors decide what to do."

In addition, the HER-2 test may also be used as a prognostic marker for breast cancer risk-assessment, and to potentially help women get new biotechnology therapies.

"Once you have the amplified gene, it is always present," said Enns. "The biopsy sample is always saved. Women who have been diagnosed years ago may want to go back and have their biopsy re-evaluated with our test to see if they have the amplified gene. That may help doctors re-evaluate a woman's treatment in a different light and see if she may be responsive to the new treatments being developed."

Vysis's stock (NASDAQ:VYSI) closed at $10, down $0.25. *