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Myriad to Launch NGS Hereditary Cancer Panel Next Month

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Myriad Genetics said this week that it would launch its next-generation sequencing-based hereditary cancer panel, dubbed myRisk Hereditary Cancer, next month, earlier than previously expected.

During a conference call reporting its fourth-quarter fiscal year 2013 results, CEO Peter Meldrum said that the hereditary cancer panel "has the potential to double our existing market."

Myriad's myRisk Hereditary Cancer panel will target 25 genes associated with an increased risk for six different hereditary cancers — melanoma, breast, colon, ovarian, endometrial, and pancreatic. As previously reported, the panel will run primarily on Illumina's HiSeq 2500 machine, will have a turnaround time of 14 days or less, and a list price between $4,000 and $4,500 (CSN 5/13/2013).

On this week's call, the company said it plans to initially target 250 physicians, with the goal of expanding later in the fiscal year and "attaining complete conversion by the summer of calendar year 2015," Mark Capone, President of Myriad Genetic Laboratories, said. Capone added that Myriad plans to present several publications on the test at conferences this fall.

Capone said that the myRisk Hereditary Cancer test will detect "at least 30 percent more deleterious breast and ovarian cancer mutations," compared to its Sanger-based BRACAnalysis test.

Since the US Supreme Court ruling in June that human genes are not patentable but cDNA is patent eligible, a number of other companies have launched, or announced intentions to launch, sequencing-based hereditary cancer panels that include the BRCA1 and BRCA2 genes (CSN 6/26/2013).

As such, Myriad's myRisk test will likely compete with these firms' offerings. During the call, Capone said that despite only recently entering the next-gen space, Myriad's myRisk test would have a number of advantages over competitors' offerings.

For instance, he said that the company has already received positive feedback from the payor community, because myRisk would provide a 30 percent increase in sensitivity over BRACAnalysis at a comparable price.

While competitors may have an advantage in terms of more experience with next-gen sequencing, those "panels have generally had very long turnaround times, in excess of 70 days, up to 90 days. They have not been reimbursed. They're not necessarily in insurance contracts," he said.

Additionally, Meldrum maintained that the company's intellectual property portfolio covering its BRACAnalysis test is strong, noting that it holds 24 patents and over 500 claims that "remain valid and fully enforceable."

Myriad has already sued two companies for patent infringement — Ambry Genetics and Gene by Gene. Ambry now includes BRCA1 and BRCA2 analysis in several of its cancer panels, while Gene by Gene began offering a BRCA1/2 test following the Supreme Court decision.

As reported by sister publication Pharmacogenomics Reporter, Ambry has countersued, alleging antitrust violations and seeking a declaratory judgment that the patent claims asserted by Myriad are either invalid or that Ambry is not infringing them.

Meldrum did not comment on these lawsuits, saying that it is company policy to not comment on ongoing litigation.

Following the call, Credit Suisse analyst Vamil Divan, wrote that he believes it is "unlikely that [Myriad] will be successful in obtaining a preliminary injunction against competitors."

Additionally, he wrote that while the myRisk Hereditary Cancer panel is Myriad's "most important" new product launch, "we do not see [Myriad] having nearly the advantage over competitors with myRisk as they did with BRACAnalysis, assuming competitors are allowed to stay in the BRCA testing market."

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