BIOTECH: Supreme Court Ruling on Gene Patent Case Clears Path to Competition
By MEGHANA KESHAVAN
San Diego’s Pathway Genomics Corp . is employing a social entrepreneurship model as it launches its new genetic test for breast cancer — entering a market made more high profile and competitive after a U.S. Supreme Court ruling last year that invalidated patents on genes.
For every breast cancer test ordered by a physician, Pathway will donate another to a woman in need through philanthropic organizations like Susan G. Komen for the Cure. The company plans to give away $10 million in free testing, or about 5,500 tests.
The test, called the BRCATrue, detects the presence of a gene mutation found among families that have multiple cases of the disease. A Salt Lake City-based company called Myriad Genetics Inc. held a patent on tests for the genes, called BRCA1 and BRCA2, and its monopoly stymied other companies from developing tests for these genes.
But the Supreme Court ruled in June 2013 that the patents on the BRCA genes — or any genes — were invalid, opening the market for companies such as Pathway Genomics to provide such tests.
This issue came into the media spotlight last year when actress and activist Angelina Jolie announced she had received a double mastectomy after learning she carried the genetic mutations that predisposed her to breast cancer. She vocally advocated greater accessibility for BRCA testing; soon after, the Supreme Court ruling was announced.
“After that happened, we accelerated our development on the hereditary breast cancer test,” CEO Jim Plante said. “And while we’re not the only test on the market, we think ours is the best.”
It’s a large and growing market: About 85 percent of Myriad’s fi scal 2013 revenue of $613.2 million came from BRCA testing. At the time, Myriad was charging more than $3,000 for these breast cancer tests. In the year since the ruling, Pathway has brought down the cost considerably, offering the BRCA testing for $1,799. Quest Diagnostics Inc., the largest player in the testing space, offers its most comprehensive version of a BRCA test for $2,500. It has been on the market since last October.
Pathway is differentiating itself from competitors like Myriad and Quest with its offer to donate $10 million in free testing; it also offers free genetic consultation with all of its testing, providing information about genetic testing — before and after it’s taken — for physicians and patients. Pathway Genomics said the BRCATrue has a sensitivity of higher than 99.99 percent. The company boasts the fastest testing turnaround time, promising results within 10 business days, Plante said.
“One out of every eight women will be affected by breast cancer in her lifetime,” said Ardy Arianpour, Pathway Genomics’ chief strategy offi cer. “By making our test more accessible, we aim to make a substantial impact in the prevention of breast cancer and help further raise awareness by partnering with global patient advocacy organizations.”
The company has been developing tests for hereditary cancers for two years, and plans to expand further into this market, by potentially offering tests for colorectal, lung and prostate cancers.
“In the near term, we plan to launch tests that cover all the cancers that have high prevalence rates,” Plante said.