A Food and Drug Administration advisory panel stunned Oncor Inc. yesterday when it failed to recommend approval of the Gaithersburg-based biotechnology company's test to predict the recurrence of breast cancer..
The company was banking on a positive endorsement from the immunology devices advisory panel to set the stage for marketing its second product in the United States.
Stock analysts who track the company had expected that the panel would back FDA approval of the test. The FDA usually follows the advice of its advisory panels.
"We are surprised and disappointed. We thought our presentation of the test data was very strong," said Stephen Turner, Oncor's founder and chief executive officer.
"This is a medical test that doesn't put anyone at risk -- and it's another technology that will be available in Europe but not available to Americans," added Mr. Turner.
The company has received approvals to market the test in
Germany, Ireland, Britain and Australia.
Sharon Snider, a spokeswoman for the FDA, said the panel thought that the pool of people used in a study to gather data on Oncor's gene-based test was too small. About 240 people had participated in a study by the company.
Ms. Snider said one panel member thought the data pool should involve about 2,000 patients.
"The panel thought the test has a lot of promise, but the company's study is too small," she said.
Mr. Turner said the company planned to work closely with the FDA to see what new information it would need to provide when the company makes a new presentation before the panel, early next year it hopes. Mr. Turner said he did not think that an entirely new study would be needed.
"We see this only as a hiccup," said Mr. Turner.
However, the unexpected delay in gaining approval for the pioneering test could cost the company money in the marketplace.
A report by Fahnestock & Co. 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.
For the first nine months of this year, Oncor reported a loss of $10.7 million on revenues of $12.6 million.
Oncor's test is known as the HER-2/neu gene-based test system. Angus Macdonald, an analyst with Fahnestock & Co.'s Boston office, has estimated that sales in Europe should help push the company into the black next year. Breast cancer is the most common form of cancer among women, with 182,000 women diagnosed last year, according to the American Cancer Society.
If detected early, the disease is considered very treatable: 94 percent of women whose cancer is spotted early survive five years or longer.
Oncor has had FDA approval since 1990 to market a gene-based test for leukemia and lymphoma. It is also working on a gene-test for lung cancer.
Oncor's stock fell 43 cents per share yesterday, to $5.87.
OncorMed Inc., a subsidiary that is attempting to market genetic tests based on research by Johns Hopkins University scientists, also took a hit in the market yesterday, its shares dropping $1 to $7.25.