By Debbie Strickland

Oncor Inc. representatives took the dais at National Press Club Wednesday in Washington to introduce a just-approved breast cancer recurrence test, Inform HER-2/neu, which the company said is the first-ever gene-based predictor of cancer recurrence to receive FDA clearance.

The news boosted the company's share price (AMX:ONC) Wednesday to $4.625, a gain of $0.375.

Although previously approved in much of Europe, the product is still unpartnered. Oncor last summer retained New York-based investment bank Lehman Brothers to assist with the effort to forge a strategic alliance with a partner.

For now, though, the Gaithersburg, Md., firm will undertake the HER-2/neu launch on its own, with distribution ramping up over the next 30 days. The test is a kit and will be performed by qualified laboratories.

With the company receiving revenue of $100 per test, the product has a market potential in the U.S. alone of more than $100 million, according to Oncor.

"We view Her-2/neu as the company's flagship product, and it is indicative of the kind of advancement we intend to make in the field of molecular medicine," said Cecil Kost, chief operating officer.

HER-2/neu is a genetic breast cancer test designed to identify HER-2/neu gene amplification, an independent marker of breast cancer aggressiveness. The test identifies the one-third of node-negative breast cancer patients at high risk for early recurrence and death.

In clinical trials, 31 percent of patients with originally localized breast cancer that had a positive HER-2/neu test died within five years of surgery, while 97 percent of patients with negative test results survived at least five years.

In the U.S., the test could offer a head start on treatment for the 40,000 women each year who face a high risk of recurrence.

Patients will not have to undergo additional surgery or other procedures — doctors can send stored post-surgical samples for testing.

"The beauty of the test is that it can be run on readily available breast cancer tissue samples," said Kost.

Oncor also is developing HER-2/neu as a molecular marker in the evaluation of prostate cancer. *

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