Genomic eyes early breast cancer market

By Julie Steenhuysen

LOS ANGELES (Reuters) - Genetic testing company Genomic Health Inc. (GHDX.O: Quote, Profile, Research, Stock Buzz) aims for about half of new early breast cancer patients each year to use its test in the next few years, Chief Executive Randy Scott said on Wednesday.

Genomic Health makes tests that predict whether women with estrogen-sensitive tumors whose cancer has not spread will benefit from chemotherapy.

Last year, the company had about 7 percent of the roughly 100,000-person market for early breast cancer patients, he said. Genomic Health aims to reach 50 percent of that market in the next three to five years, he said.

One potential sticking point for the company may be recent interest the U.S. Food and Drug Administration has taken in Genomic Health and a handful of other test makers.

"We just received the letter from them in January. We know they are interested in this space," said Scott, speaking at the Reuters Biotechnology Summit in Los Angeles.

Redwood City, California-based Genomic Health's breast cancer test, Oncotype DX, is currently regulated by the Centers for Medicare and Medicaid Services, the federal health insurance program for the elderly and poor.

FDA spokeswoman Kristen Neese signaled that the agency may be looking to regulate at least some of these types of diagnostic tests.

"These tests that are developed and intended for use in the lab are not currently regulated by FDA. However, depending on the intended use of the product in a clinical setting or use outside a lab setting, there may be situations in which the product needs to be reviewed by the agency," she told Reuters.  Continued...