After ending its own testing program for the BRCA1 and BRCA2 breast cancer genes in July 2001 because of a legal threat, the British Columbia Cancer Agency (BCCA) has resumed testing — in Ontario. The BC government ended the agency's own testing program after Myriad Genetics filed an exclusive patent for the gene-testing process (see CMAJ 2001;165[6]:812). Ontario allowed the tests to continue despite the patent claim, so testing of BC patients will now take place there instead.
The cost in Ontario is about one-third the price charged by Myriad Genetics, but the Ontario laboratory does not charge patients because its expenses are covered by a research grant. Women are required to participate in a study by completing questionnaires; they deal directly with the laboratory, so the BCCA does not face any legal liability.
Before this arrangement was made, the only option available to women in BC was to pay Can$3800 to Myriad Genetics, which provides results in about 6 weeks; about 6 of the BC women did this. Results from Ontario arrive in about 6 months.
Ending the test program was a bitter pill for the BCCA to swallow. “We had been testing for BRCA mutations for at least 5 years, our laboratory was totally geared up to do that work, it was an integral part of the service we provided and it was an area for research and development,” says Dr. Simon Sutcliffe, the CEO. He says other provinces have continued testing, even though they received the same cease-and-desist order from Myriad Genetics as BC.
About 300 tissue samples were awaiting testing at the BCCA when its program ended, and those women have been contacted regarding the Ontario arrangement. Dr. Charmaine Kim-Sing, medical leader of the Hereditary Cancer Program, said the response has been “overwhelming.” Sutcliffe doesn't know how long the arrangement with Ontario can continue, but he is optimistic that another solution can be found if needed.
“Myriad has patented the gene and any and all mutations in the genes and any knowledge that might arise from the genes, now or in the future. Neither the genes nor the mutations are innovations. Most of us feel that patenting is absolutely fine if it pertains to a [true] innovation or invention, but to actually lock the gene away from any form of further testing or research and development is an inappropriate piece of patenting.” — Heather Kent, Vancouver