UTAH FIRM TO PROVIDE NEW TESTING TO SCREEN FOR BREAST, OVARIAN CANCER.

Byline: Richard Saltus The Boston Globe

A Utah biotech firm Thursday opened the way for widespread testing for inherited breast and ovarian cancer genes, saying it will test blood samples drawn by any doctor who believes a woman is at high risk of carrying the genes.

The test is intended only for women likely to have a genetic susceptibility - because they or a close relative have developed breast or ovarian cancer at an early age, or they know a relative carries the mutant gene - officials of Myriad Genetics Inc., said in announcing that the tests will become commercially available next week.

Critics, including women's health groups and some geneticists, have said it is premature to offer the tests commercially. They say that the information has limited value, because there's little a woman can do to forestall the cancers if she carries the gene and that it could lead to discrimination against her in insurance or employment.

For a woman already diagnosed with cancer, the test would give her and her physician useful information about the chances of a recurrence and also would show whether her daughters need worry about inherited susceptibility.

But Myriad officials said they will establish a registry, located at Dana-Farber Cancer Institute in Boston, to collect information on the consequences of testing in an effort to determine its benefits. With their patients' consent, physicians will notify the registry of results of the genetic tests, any cancers that develop later and the outcome of any preventive measures.

Dr. Fred Li, who will head the Dana-Farber registry, said the information would ``provide new knowledge'' about the effectiveness of preventive strategies and ``should eventually lead to better care for women and their families.'' The data will be kept confidential and anonymous, Li emphasized.

An unknown number of women have undergone testing in the past year or two, some under research conditions and a small number through another firm, OncorMed, of Gaithersburg, Md.

Scientists at Myriad discovered the genetic sequences of the two mutated genes, called BRCA1 and BRCA2, which may cause 5 to 10 percent of all breast and ovarian cancers - and about 90 percent of those due to inherited predispositions.

A woman who undergoes testing because of a strong history of early breast or ovarian cancer in her family and learns she carries a mutant BRCA1 gene faces an 82 percent chance of developing breast cancer and a 44 percent chance of developing ovarian cancer by age 70, say Myriad scientists.

Mark Skolnick, a Myriad scientist and vice president, said that new, unpublished research has revealed a higher rate of BRCA1 mutations among older breast and ovarian cancer patients than had been thought.

Although even prophylactic removal of the breasts or ovaries isn't certain to prevent the cancers, some women choose these drastic measures, along with more frequent X-rays and other monitoring tests. They may also use the information to make family planning or life decisions. The test will identify those women in high-risk families who do not carry the mutation; their risk will then drop to the same level that most women face.

The company said it will insist that any physician sending in a patient's blood sample must have fully informed the woman about the consequences of testing, and must have obtained her signed consent. Genetic counseling before and after testing is strongly recommended as well.

Myriad will charge $2,400 to carry out the laborious and demanding gene test, officials said. However, if a gene mutation is identified, other family members can be tested for that specific mutation for $395.