The market leader in cancer panel gene testing flooded the zone at the annual meeting of the American Society of Clinical Oncology in Chicago. Salt Lake City-based Myriad Genetics presented several studies showing that the comprehensive approach to testing encompassed in its 25-gene myRisk heredity cancer test results in fewer undetected cancer genes than single-gene testing.
Different cancers are linked to various deleterious genetic mutations, like breast and ovarian cancer with those located on the BRCA1 and BRCA2 genes, and colon cancer with those associated with Lynch syndrome. But the data presented by Myriad — which has a 90 percent market share in panel testing, according to company spokesman Ron Rogers — show that multiple genes are risk factors for the many types of cancers.
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A study of 1,100 colon cancer patients conducted at the Dana-Farber Cancer Institute in Boston found that 10 percent of them had a deleterious mutations, but only 3 percent of the patients had a mutation associated with Lynch syndrome. A test for only the genes associated with Lynch syndrome would have missed the other 7 percent of patients who were also carriers of a mutation that puts them at higher risk.
“There are a lot more genes associated with colon cancer than we previous understood,” said Myriad CMO Dr. Johnathan Lancaster in an interview. In particular a surprisingly high 1 percent of patients had a BRCA 1 or 2 mutation.
Lancaster noted that patients in the study consisted of 1,100 consecutive patients who provided a blood sample. In other words, the sample was not biased towards those who had a family history of cancer, which would increase the odds of finding various mutations.
Similarly, another study conducted by Temple University found that among 5,020 women with ovarian cancer, one-third of the deleterious mutations were not located on the BRCA genes or Lynch syndrome, which are known to be associated with the disease.
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And when specialized clinicians were asked to list up to 8 deleterious genetic mutations an individual might have based on family history, they were unable to successfully name the correct mutation about 25 percent of the time, in another study conducted by Myriad, Stanford University and the University of Southern California.
The clinical implications of finding — or not finding — deleterious mutations are significant, according to Lancaster. They can include removal of organs to prevent recurrence or prevent the disease all together, a step famously taken by actress and BRCA carrier Angelina Jolie.
The information gained by panel testing is an “invaluable gift” because it can help reduce the risk of cancer in family members who might also be carriers of the deleterious mutation and should also get tested, Lancaster said.
Data showing that mutations closely linked to one type of cancer are also relatively common in patients with another type of cancer reinforce the new way thinking about the disease; not as an ailment of individual organs, but a molecular dysfunction linked to mutated genes.
The changing competitive landscape also necessitated Myriad’s move toward panel-testing and away from the single-gene approach. The myRisk panel is responsible for about 80 percent of the company’s cancer testing volume, Lancaster said.
Following a 2013 Supreme Court decision that overturned single-gene patents and Myriad’s monopoly on BRCA testing, competitors like Invitae and Quest Diagnostics began offering the service at lower costs, forcing the incumbent to diversify.
To that end, Myriad recently purchased Germany’s Sividon Diagnostics for €35 million ($39 million) upfront and up to €15 million ($17 million) in milestone payments to enlarge its role in diagnostics for breast cancer. Myriad previously helped distribute Sividon’s EndoPredict RNA-based breast cancer prognostic test in Europe.
Unlike Myriad’s other, laboratory-developed tests, results from Sividon’s EndoPredict can be obtained in various locations, not just specialized centralized laboratories for genetic testing. The move marks Myriad’s initial foray into “kit-based” side of the industry, a point emphasized by company CEO Mark Capone.
Lancaster said the acquisition part of the Myriad’s evolution from hereditary cancer company to a personalized medicine company. He said it aims to be a “trusted advisor” that uses molecular diagnostics to determine whether a patient is at risk of a disease, whether a patient has a disease, the aggressiveness of the disease and finally, what therapy should be used to treat the disease.
Sividon’s EndoPredict RNA test answers the third question. By predicting which patients are at risk of disease progression, it helps clinicians decide whether to conduct chemotherapy.
Lancaster said Myriad aims to introduce the test in the U.S. in 2017, and promised the publication of data showing that EndoPredict is superior to Genomic Health’s U.S. incumbent, Oncotype DX.
