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Myriad Launches Hereditary Cancer Panel to Early-Access Customers

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Myriad Genetics last week launched its next-generation sequencing-based hereditary cancer panel to early-access users.

As the company previously said, it will initially launch its panel as an early-access product to 250 healthcare providers (CSN 8/14/2013). According to a company spokesperson, by early next year it will expand its access phase.

"The goal of this phase of the launch is to ensure that we are responsible and meeting our customers' expectations in terms of accuracy and turnaround time," the spokesperson told Clinical Sequencing News. "Also, we want to make sure healthcare providers receive the appropriate training before using this new test."

The myRisk panel targets 25 genes associated with an increased risk for eight different hereditary cancers — melanoma, breast, ovarian, colon, endometrial, pancreatic, prostate, and gastric.

The company uses the RainDance Thunderstorm to amplify the 25 genes. Sequencing is done primarily on the Illumina HiSeq 2500 to 1,000-fold coverage and variants are called via in-house developed software. Sanger sequencing is used to fill in any gaps and to confirm point mutations. Deletions and duplications are called from the sequencing data and confirmed with microarray. The test will have a turnaround time of 14 days and a list price between $4,000 and $4,500.

Myriad will now have to compete with other firms like Ambry Genetics and GeneDx, both of which have launched hereditary cancer panels since the US Supreme Court struck down some of Myriad's patents on the BRCA1 and 2 genes, and others that plan to soon launch such panels (CSN 6/26/2013). Ambry, which has been offering hereditary cancer panels without BRCA1 and 2 genes for almost two years, added those genes to its test immediately following the June ruling, while GeneDx launched a suite of hereditary cancer panels that assess the BRCA1 and 2 genes late last month, including a 35-gene comprehensive panel for breast, colorectal, endometrial, ovarian, pancreatic, and uterine cancers as well as attenuated familial adenomatous polyposis and familial adenomatous polyposis (CSN 8/28/2013).

Ambry's Senior Vice President of Business Development, Ardy Arianpour, told CSN that he thinks the introduction of Myriad's panel to the market, despite competing with Ambry's CancerNext panel, could actually help Ambry's business.

Myriad's panel "justifies the fact that we've been doing the right testing," he said. "Because Myriad has such a big sales force and marketing push, everyone will know about the myRisk product," he said, which will "increase awareness about panels in general and increase our business."

The competition has also spurred a number of lawsuits. Myriad is currently suing both Ambry and Gene by Gene for patent infringement, as reported by sister publication Pharmacogenomics Reporter (PGx Reporter 7/10/2013). The two firms have in turn countersued, alleging antitrust violations by Myriad. GeneDx has so far not become entangled in the legal fray.

The hereditary cancer panels offered by Myriad, Ambry, and GeneDx are similar, but with slight differences. For instance, Myriad calls both point mutations and deletions and duplications from the next-gen data and confirms with Sanger and arrayCGH respectively. By contrast, Ambry and GeneDx use arrays as the primary method for calling deletions and duplications.

Additionally, the companies' panels differ in the number of genes they analyze. Myriad's myRisk panel analyzes 25 genes, GeneDx's comprehensive cancer panel assesses 35 genes and Ambry is currently in the process of bumping up its CancerNext panel from 24 genes to 45.

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