© 2000 by Oxford University Press
Journal of the National Cancer Institute, Vol. 92, No. 8, 596,
April 19, 2000
© 2000 Oxford University Press
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NCI-Myriad Agreement Offers BRCA Testing at Reduced Cost
An agreement between the National Cancer Institute and Myriad Genetics of Salt Lake City provides one model for how gene patent holders can work with the scientific community to support research.
Myriad holds the commercial rights to the BRCA1 and BRCA2 breast and ovarian cancer susceptibility genes. Some critics contend that such patents hamper research because patent holders can prohibit others from performing genetic tests and charge high fees for their services (see News, Feb. 2).
But Greg Critchfield, M.D., president of Myriad’s diagnostic laboratory subsidiary, said it is in the company’s interest as well as the public’s to promote and facilitate research on the genes. This fact led Myriad to offer researchers within or funded by the National Institutes of Health full BRCA gene sequencing for $1,200 per person, just less than half the commercial cost, netting Myriad no profit.
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"We understand the value of having research data about the utility of our test," Critchfield said. "We have always encouraged labs to perform research." Before the commercial launch of the test in 1996, Myriad performed thousands of tests for free "to help the world understand the biology of BRCA testing," he said, and the company now sponsors follow-up research on the health and psychosocial status of people testing positive.
Critchfield justified the $2,580 charge for commercial BRCA testing, citing the need to fully sequence the very large genes. More than 1,000 different mutations have been found in the two genes, and 35% of mutations Myriad finds are novel ones. If a specific mutation is identified in a family (or a group of mutations, such as those common among Ashkenazi Jews), the company can test for one or a few mutations at much reduced cost, he said.
The University of Pennsylvania’s Arupa Ganguly, Ph.D., independently developed a BRCA test, which the university offered to patients for a $1,900 fee until Myriad enforced its patent and stopped it in 1998. Penn continued to offer testing to other members of the NCI-funded Breast Cancer Genetics Network for $1,000, typically paid by the researchers’ grants. In 1999 Myriad ordered Penn to cease this use of the test, although Ganguly still uses it in her own research. Ganguly said Myriad offered her a license to do follow-up testing of identified mutations after Myriad did the initial screening.
"But my forte was in screening the gene," Ganguly said, "so I refused to accept that license, because I said if I cannot do the whole thing, then I won’t do anything."
Myriad’s offer of reduced-cost testing is viewed as a boon by NCI, said Kathy Sybert, Ph.D., of the institute’s technology transfer office.
"We thought it was a great idea to advance the research," she said, "because we’re looking at some very large population-based studies in the future, and the testing costs could get to be pretty phenomenal."
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