Less than one month after pop-culture icon Angelina Jolie’s double mastectomy brought widespread attention to a breast- and ovarian-cancer genetic test, experts say a U.S. Supreme Court ruling will make that pivotal test more affordable.
The high court’s ruling last week struck down a Utah company’s monopoly over a key gene-based diagnostic test used to predict the likelihood that a woman will get breast or ovarian cancer.
Myriad Genetics charged more than $3,000 to detect genetic mutations that are associated with a higher risk of breast or ovarian cancer.
Within hours after the Supreme Court ruled that companies such as Myriad cannot patent human genes, other labs announced they would offer less-expensive versions of diagnostic tests that detect potentially harmful mutations of the BRCA1 and BRCA2 genes. Myriad had held the patent on the genes since the 1990s and blocked efforts by other labs to develop tests based on those two genes.
A Texas lab, DNATraits, said it would begin selling the test for $995. Ambry Genetics, a Southern California lab, said it is now taking orders for the breast- and ovarian-cancer gene tests starting at $2,200. GeneDx, a Maryland company, said it will soon begin selling the test though it would not disclose its price.
“We feel it’s the right decision for both patients and the future of genomic medicine,” said Sherri Bale, founder and managing director of GeneDx. “We will compete very well on our prices as well as our technology, customer service and quality of testing.”
Mike Janicek, a Scottsdale obstetrician and gynecology oncologist, said the BRCA test has been a lifesaver for women with a strong family history of breast and ovarian cancer. Patients like Jolie — who disclosed her lifetime risk of breast cancer was 87 percent — may choose to take preventive measures such as surgery or drug therapies after discovering the mutation.
“Most doctors and patient advocates feel this is a good decision,” Janicek said.
Others predict that doctors and patients may not immediately embrace upstart labs that offer less expensive versions of the test. Myriad’s reputation and connections with doctors who offer the test will give it an advantage over competitors.
“You have name recognition already and have gotten in with all the doctors, and insurance companies know how to bill your tests, said Mary Anthony Merchant, an intellectual-property attorney with Ballard Spahr, a Philadelphia-based law firm with offices in Phoenix. “A competitor may come in and do the testing differently. Will they be as reliable?”
Experts who track genetic medicine say the test’s affordability is just one benefit of the high court’s decision. Some predict the ruling will hasten the use of genetic testing and even remove another barrier for scientists who aim to research and discover more about tests and drugs tailored to an individual’s genes.
“The court went as far as it needed to go to free researchers and competitive testing labs,” to allow them to work without fears of infringing a patent, said Paul Burns, a Scottsdale intellectual-property attorney. “We now have a clear view of what the Supreme Court will not allow.”
More and more companies are selling tests that evaluate groups of genes to give doctors and patients more information on cancer risk.
When the Human Genome was sequenced a decade ago, some researchers believed the mystery of disease triggers would be unveiled in single genetic mutations such as BRCA1 or BRCA2. That prompted a gold rush of biotech companies and scientists securing an estimated 3,000 to 5,000 individual gene patents with the specter of making the cost of genetic tests and therapies “unacceptably high,” according to the Hastings Center, a bioethics research institute.
But single disease-triggering mutations such as BRCA1 and BRCA2 proved to be the exception. More scientists are studying clusters of genes and how those may fuel growth of cancerous tumors, said Gary Marchant, director of Arizona State University’s Center for Law, Science and Innovation.
Marchant cited the example of the Oncotype DX test that examines 21 genes on a breast-cancer tumor to predict the likelihood of recurrence.
“It’s not the individual genes that are powerhouse on biotech anymore,” Marchant said. “For most health conditions, you will need to test groups of genes together” to assess risk.
In that sense, Marchant said that the Supreme Court ruling could benefit future research. He said if companies were able to patent human genes, it could discourage scientists to examine groups of genes in tandem and make diagnostic tests more expensive for consumers.
With the nation’s high court giving the green light to researchers, Janicek said he envisions that people who can interpret and explain genetic discoveries will play a more important role.
Genetic counselors, for example, explain risks of genetic tests to patients while many doctors don’t have the time or expertise to track the latest discoveries.
“Sequencing the genome is an open book; the problem is how do we interpret the open book?” Janicek said. “We know the letters in the book; how do we understand the sentences and the paragraphs?”
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