FACTBOX-U.S. Supreme Court says human genes cannot be patented
June 13 (Reuters) - The U.S. Supreme Court decided on Thursday that human genes cannot be patented, but said patents on synthetically produced genetic material are valid.
The issue has gained importance for patients in recent years as scientists make progress in identifying the specific genes, or mutations, that determine the course of disease.
The Supreme Court case involved Myriad Genetics Inc and its patents on two genes known to raise the risk of breast and ovarian cancers.
Here is a breakdown of the issues:
* BRCA1 and BRCA2 - breast cancer susceptibility genes 1 and 2 - are human genes that belong to a class known as tumor suppressors. A permanent change, or mutation, in these genes has been linked to hereditary breast and ovarian cancer.
The likelihood that an individual case of breast or ovarian cancer is due to these mutations is highest in families with a history of multiple cases of those cancers. Since not every woman in such families carries the mutated genes, tests such as the one sold by Myriad Genetics were developed to screen women with close family members who developed breast or ovarian cancer.
* The National Institutes of Health estimates that about 2 percent of adult women in the general population fit the profile of needing to be tested for BRCA mutations.
About 12 percent of women will develop breast cancer sometime during their lives, according to the NIH, but that probability rises to about 60 percent of women with BRCA mutations.
Lifetime risk for ovarian cancer among women in general is about 1.4 percent, compared with between 15 percent and 40 percent of women who have harmful BRCA1 or BRCA2 mutations.
Because of this heightened cancer risk, some women who test positive for the mutations, such as actress Angelina Jolie, have chosen to have their breasts or ovaries surgically removed.
* The Myriad test, which costs more than $3,000, is generally covered by insurers.
Analysts expect that the court's ruling will lead to increased competition in the diagnostics market, but said practical implementation will take time since doctors will need to be convinced that other tests are valid and reliable. Immediately after the ruling, academic researchers and at least one genetic testing company said they could soon provide competing tests.
(Reporting By Deena Beasley. Editing by Andre Grenon)