OncorMed to market test for mutation Firm says gene flaw could show tendency for some cancers

July 24, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

OncorMed Inc., a biotechnology company that has developed genetic tests for cancers and other diseases, says it will begin marketing next week a breakthrough test that can predict whether some women with family histories of breast and ovarian cancer have a strong genetic predisposition for the diseases.

The company says the new test can detect more than 60 percent of mutations in a recently discovered gene, called BRCA2. Research has shown that mutations in the BRCA2 gene can lead to breast and ovarian cancers.

The test is being further developed to detect almost 100 percent of the mutations, company officials said.

The Gaithersburg company will be the first company to hit the U.S. market with a test for the BRCA2 gene, said David Sobell, a Boston-based analyst who covers OncorMed for Rodman & Renshaw.

A competitor, Myriad Genetics, is expected to launch marketing of a BRCA2 test next year, Sobell said. But OncorMed, for now at least, appears to have the stronger distribution network as a result of the clientele it has built for other genetic tests it already offers, the analyst said.

The BRCA2 test initially isn't expected to have a big effect on OncorMed's revenue stream because regulatory and social issues regarding genetic testing are still to be resolved, Sobell said.

But, once those issues are resolved and physicians, insurers and the general public understand and appreciate the potential usefulness of genetic tests in managing patient health, the test could provide an important revenue source to OncorMed, Sobell said.

The company reported that it lost $6.5 million on sales of $300,000 in 1995.

Yesterday, shares in OncorMed closed at $4.25, down 50 cents.

'Market will build'

"There's a lot of uncertainty right now of just how big a market there is for this kind of test," Sobell said.

"However, there's no question that the BRCA2 test is an important new technology that could really benefit people who are at a high risk for some cancers to manage their health. Eventually the market will build for this and other genetic tests."

Sales of OncorMed's BRCA2 test, and a similar genetic test for breast and ovarian cancer that OncorMed offers -- called the BRCA1 test -- should get a boost if Congress passes health care reform measures next year, analyst Sobell said.

Those measures are under consideration now and would bar insurers and managed-care companies from dropping or discriminating against people who have taken gene tests and found they have a strong likelihood of contracting a specific disease.

Sobell said sales also should get a boost once data is collected and distributed from early users of the test showing its reliability.

Dr. Leslie Alexandre, vice president for corporate affairs at OncorMed, said the BRCA2 test will be marketed to oncologists, obstetricians and other physicians as appropriate only for women who have family histories of breast or ovarian cancer.

$300 to $1,000

Those women also must have a living relative no more distant than a first cousin who has breast or ovarian cancer, the doctor said.

"This test is not meant to be used as a general screen for the general public," Alexandre said.

Women who agree to take the test would be given counseling before and after the test so they understand the test and its implications for their health care, she said.

The company expects the test to cost between $300 and $1,000, depending on how many mutations of the BRCA2 gene the company searches for.

Breast cancer is the most common form of cancer among women, with 182,000 women diagnosed with it 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.

Between 5 percent and 10 percent of breast cancer is inherited. Researches have found that mutations in the BRCA1 gene account for about 45 percent of the inherited cases, while mutations in BRCA2 account for about 35 percent.

Women who are found to have a BRCA1 or BRCA2 mutation have an 85 percent chance of developing breast cancer and have an increased risk of developing ovarian cancer, Alexandre said.

Pub Date: 7/24/96

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