Oncor wins OK to market its new breast cancer test Inform HER-2/neu offers gene-based help in detection

January 01, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

Oncor Inc. yesterday won approval from the Food and Drug Administration to market its gene-based test for breast cancer in the United States.

The test, known as Inform HER-2/neu, will be the first gene-based test available in the United States to predict the recurrence of breast cancer. Oncor is banking on it to be a big revenue generator.

"This is blazing new trails," said Oncor President Cecil Kost. "We are thrilled with the news. This approval validates our approach to molecular medicine and its usefulness as a diagnostic."

Oncor Chief Executive Officer Stephen Turner said, "This is a very gratifying day, one which marks the beginning of a new era in medicine."

Cancer experts say early diagnosis of cancer and the possibility of its recurrence can be critical in fighting the disease.

Dr. Jeffrey S. Ross, chairman of the department of pathology at Albany Medical Center in New York, participated in clinical trials on the test.

Ross said Inform should prove a useful tool for oncologists and help them make a "more informed choice about treatments." He noted that the test predicted "which women would have a high risk of relapse, and which women were more likely to die of the disease."

Breast cancer is the most common form of cancer among women, with 182,000 women diagnosed last year, according to the American Cancer Society. More than 40,000 U.S. women learn each year that their cancer has recurred.

Kost said the company, which develops gene-based tests for cancer and other diseases, expects the Inform test to emerge as a significant revenue generator for Oncor, though he declined to cite specific estimates. The test should be on the market by the end of January, Kost said. While the company is initially banking on new cases of breast cancer to open up the U.S. market for the test, Oncor said the test could also be used on tissue samples taken from tumor cells kept on file for many years.

In 1995, when Oncor first approached the FDA for approval to market Inform, analysts had high hopes that it would become an important revenue generator, possibly moving the company into the black.

Fahnestock & Co., which no longer has an analyst covering Oncor, estimated in 1995 that the U.S. market could be worth $150 million a year if all breast cancer survivors received the test once a year.

Tests on new cases represent an additional market of $17.5 million, Fahnestock estimated.

No analysts currently cover the company.

Oncor executives don't anticipate market resistance to the test since it would be used only after a woman has been diagnosed with breast cancer.

Genetic tests to predict whether a person has a strong predisposition to a particular cancer -- called genetic screening -- LTC have encountered sluggish sales because of fears that the information could result in discrimination by employers and health insurers.

The Inform test detects extra copies of the HER 2/neu gene. Scientists believe that the gene plays a role in spurring cancer cell growth.

Oncor's test determines which level of risk breast cancer patients have of seeing their cancer recur at some point after surgery to remove tumors.

The test is conducted using a tissue sample of the tumor. It

takes 48 hours for a result. The company expects the test along with laboratory fees to cost several hundred dollars. Oncor will sell test kits to disease-testing laboratories trained to use it.

The company envisions the test emerging as an important adjunct to currently available tests which are used to assess the potential aggressiveness of breast cancer tumors. These include test for tumor size and one to measure a tumor's appetite for estrogen.

Kost said the company plans to market and manufacture the test itself.

The company hopes to convince oncologists, pathologists and managed heath care groups that Inform HER-2/neu can provide "a much better portrait of a patient's cancer from which treatment decisions can be made."

The company has been working for two years to get FDA approval to market the Inform test.

In late 1995, an FDA advisory panel rocked the Gaithersburg biotechnology company when the panel said it would not recommend marketing approval.

As a result, Oncor conducted additional tests on previously tested tissue specimens and developed training materials showing doctors and others how the test is to be done to ensure accuracy.

Pub Date: 1/01/98

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