Life Technologies this week launched the Ion AmpliSeq BRCA 1 and BRCA 2 panel for research use in the US, which some industry observers saw as increasing the competitive pressure on Myriad Genetics, the current market leader in BRCA testing for hereditary breast and ovarian cancer.
"Life's introduction of two new Ion AmpliSeq cancer panels, including one focused on BRCA 1 and 2 raised some investors' eyebrows today, given the patent estate that Myriad currently has in place around these two genes," wrote Credit Suisse analyst Vamil Divan. The other AmpliSeq panel Life launched was for colon and lung cancer, which gauges more than 500 mutations in 22 genes.
Myriad's broad patent suite on isolated BRCA 1 and BRCA 2 sequences allows it to monopolize the BRCA testing market in the US for assessing patients' risk for familial breast and ovarian cancer. The company's BRACAnalysis test accounted for approximately 74 percent of Myriad's total revenues for the second fiscal quarter.
By launching the BRCA1/2 AmpliSeq panel as a research-use-only test, however, Divan believes that Life is shielding itself from any responsibility if its customers choose to use its RUO panel to make patient treatment decisions.
According to a draft guidance issued by the US Food and Drug Administration, manufacturers of RUO and investigational-use-only products are responsible for ensuring that such products are not being used to make medical decisions for patients. However, the FDA has acknowledged that this particular guideline may be hard to enforce since some manufacturers of RUO/IUO products may not have any way to monitor how their customers are using these types of products, while other companies may be knowingly turning a blind eye to customers using RUO/IUO materials in patient care (PGx Reporter 2/13/2013).
The launch of the RUO AmpliSeq BRCA panel comes just as the US Supreme Court is slated to hear Association for Molecular Pathology v. Myriad, a lawsuit in which patients, researchers, and healthcare providers are challenging Myriad's patents on isolated BRCA 1 and BRCA 2 sequences underlying the BRACAnalysis test. "While it is unlikely that the [AmpliSeq RUO] panel will have any impact on the volumes Myriad can obtain in the near-term with their BRACAnalysis test in the US clinical diagnostic market," the launch of Life's panel "does highlight the increased competitive pressures that exist around BRACAnalysis if and when the patent protection Myriad currently enjoys is removed, either later this year by the Supreme Court or in the coming years as the patents expire," Divan said in his note.
In a statement announcing the launch of the BRCA panel, Life noted that the AmpliSeq test analyzes the coding regions of the tumor suppressor genes BRCA1 and BRCA2. The test involves a PCR reaction and then sequencing by Ion semiconductor sequencing.
Life believes that the AmpliSeq BRCA panel is a faster and cheaper option compared to currently available tests. The company highlighted that the test can yield results in less than 24 hours. Life has also tested 65 samples with the panel and gauged all "expected mutations," the firm said in a statement.
"The Ion AmpliSeq BRCA panel does provide clinicians with a faster and cheaper way to work with BRCA 1 and 2," Divan agreed in his note. "In Europe (where the regulatory and legal landscape around BRCA and lab-developed tests differs markedly from the US), the test will also likely gain some traction as a diagnostic test."
Another investment bank, Mizuho Securities, conducted a diagnostic survey in the first quarter and found that more than 70 percent of labs it spoke to said they would not perform BRCA testing mainly due to the lack of technical capabilities to conduct such testing. Less than 15 percent of surveyed labs said they would perform testing even without access to Myriad’s large proprietary clinical database of gene-disease associations.
"Interestingly, Life Technologies' AmpliSeq BRCA1 and BRCA2 panel, run on Ion Torrent, now provides labs with the capability to perform the test, although we note the product is RUO and not for diagnostic use," Mizuho analyst Peter Lawson wrote in a note to investors.
Researchers from Radboud University in The Netherlands and the University of Porto in Portugal developed the Ion AmpliSeq BRCA1 and BRCA2 panels. "A global consortium will further test the panel, with plans to validate and implement it in their labs," Life said in a statement.
Even though in the US, Life can only sell the AmpliSeq BRCA 1/2 panel for research use, the mere availability of the platform raises questions as to whether Myriad will be able to hold on to its leadership position in this market in the long term. "Even if the panel’s use is limited to the research setting in the US for now, any greater understanding that the scientific community develops around the BRCA genes will likely limit the advantage Myriad currently holds as competitors enter the market in the US and abroad," Divan said in his note.