Breast cancer test OK'd abroad Md. biotech firm gets nod to sell product in Europe, Australia


Oncor Inc., a Gaithersburg biotechnology company, has received government permission to market in Europe and Australia a test that some experts believe could revolutionize the way doctors diagnose and treat breast cancer.

The diagnostic test, which is still awaiting approval for marketing in the United States, can predict how likely a breast cancer patient's disease is to recur.

That is significant because breast cancer patients whose disease recurs elsewhere in the body have lower survival rates than those whose cancer is diagnosed and treated early, said medical experts.

Oncor's test, which took five years to develop, is the only gene-based test for cancer recurrence that has received permission to be marketed. The development should help move the publicly held company, which is developing gene tests to detect cancers and other diseases, into the black for the first time since its founding in 1984, say stock analysts.

"The test is a significant step forward for the company and could become a standard of care. It literally helps the physician determine how invasive a breast cancer will be," said Angus Macdonald, an analyst with Fahne stock & Co.'s Boston office.

He predicts that the company, which lost $6.8 million during the first half of this year, should turn a profit in 1996, thanks in part to its ability to market the test in several countries in Europe -- including Germany, Ireland and Britain -- as well as Australia.

Physicians might routinely order the test for patients diagnosed with breast cancer so they can improve their course of therapy.

tTC That would obviously be good news for patients.

But it could bode well for doctors, too. Breast cancer treatment has emerged as the leading reason doctors are sued for malpractice, noted Mr. Macdonald.

If the test is used, he said, doctors could say they did everything possible to diagnose and treat the disease.

While the test has not yet been approved for marketing in the United States by the Food and Drug Administration, Mr. Macdonald and others believe that permission should not be far off since the test holds great promise for helping doctors get a better handle on how best to treat breast cancer patients and reduce lawsuits.

"There is a very strong need for this kind of test. There is nothing like it on the market," said Mr. Macdonald.

A report by Fahnestock on Oncor in June estimated that the United States alone could represent an annual market of $150 million if all breast cancer survivors received the test once a year, and that tests on new cases could bring in $17.5 million.

Breast cancer is the most common form of cancer among women, with 182,000 women diagnosed last year, according to the American Cancer Society. About 46,000 women will die this year of the disease, the cancer society estimates. If detected early, the disease is considered very treatable: 94 percent of women whose cancer is spotted early survive five years or longer.

Dr. John Stevens, an Atlanta-based cancer expert and vice president for research and grants for the American Cancer Society, said Oncor's test presents "a whole new approach" to the diagnosis and treatment of cancer.

The test holds the potential for allowing doctors to identify which patients to schedule for intensive therapy, while sparing those who would not be candidates for such therapy, Dr. Stevens said.

In medical terms, Oncor's test is known as the HER-2/neu gene-based test system, which means the test is conducted on the DNA level by looking at the building blocks of cells.

Stephen Turner, Oncor's founder and chief executive officer, said the company plans to begin shipment to the seven countries in Europe where it has received permission to market HER-2/neu between October and December.

Mr. Turner declined to predict revenues from the sale of the test in Europe and Australia, other than to say it should represent a "main component" of Oncor's revenues next year.

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