Patenting move ends BC's gene-testing program

Patenting of a gene-sequencing process has forced the British Columbia Cancer Agency (BCCA) to suspend its testing for the BRCA1 and BRCA2 breast cancer genes. A Salt Lake City company, Myriad Genetics, filed an exclusive patent for the process this spring and notified the BC government it would be asserting those rights. After receiving legal advice, the Ministry of Health decided to stop providing testing while its lawyers examine the validity of the claim in Canada. Alberta has taken the same step.

Ministry of Health spokesperson Dr. Neil Fadin is worried that the move by the American company is “the thin edge of the wedge”; 300 samples from patients participating in the BCCA's Hereditary Cancer Program were awaiting testing when the ministry pulled the plug (see CMAJ 1999;161[9]:1175).

The gene testing done by the BCCA costs about $1200 per test, but it takes up to 18 months to get the results because of staffing limitations; the Ministry of Health covers the cost. About 80 families enter the program each month and about 1500 joined in the last 5 years, said Dr. Charmaine Kim-Sing, the program's medical leader.

Myriad Genetics will now charge patients $3850 for the test, with results available in 6 weeks. All test samples will now go through MDS Laboratories, Myriad Genetics' Canadian partner.

Both the Ministry of Health and BCCA have told newly registered patients in the program that the fees are their responsibility if they proceed. Dr. Simon Sutcliffe, CEO at the BCCA, says the program will continue to offer its other genetic counselling services, and any test results patients purchase from Myriad Genetics will be incorporated into their programs. Kim-Sing says BRCA gene mutations are rare and are only found in about 6% of women entering the program. The gene's presence does not indicate that a woman will get breast cancer. “The predictive power of the gene is relatively low,” said Sutcliffe.

Jan Engemoen, executive director of the BC/Yukon Branch of the Canadian Breast Cancer Foundation, said the testing is “very important to those women and their families who go through the [genetic] counselling and are ready to take the test. We hope that this will be resolved and that the Ministry of Health will reconsider its decision [not to pay].” The group gave the BCCA pilot funding for gene testing and contributed to the purchase of its DNA sequencer.

It is too early to predict the impact of the cost increase on the BC program. Sutcliffe says it is the start of a process that will characterize all cancer gene testing, “so this is just opening the door to discussions of how this should be handled.”