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Myriad Partners with RainDance for Front End of NGS-based Hereditary Cancer Panel Test

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As an indication of getting closer to launching its first next-generation sequencing-based diagnostic test, Myriad Genetics said today that it will use RainDance Technologies' microdroplet PCR technology as the front end of an NGS-based Hereditary Cancer Panel test.

The companies signed a multi-year supply agreement that "marks an important milestone in our preparation for the future launch of our next-generation HCP test," said Mark Capone, the president of Myriad Genetics Laboratories, in a statement.

According to Myriad, the test will analyze "numerous" high-prevalence genes that "play a critical role in inherited cancer risk." It will cover "a broad spectrum" of cancers, providing "a more complete assessment of inherited cancer risk than any currently marketed product."

Myriad did not say when it intends to launch the HCP test, or the sequencing platform on which it will run.

According to two recent company presentations, the test is in analytical validation and will enter clinical validation next, the last step before launch. Three other tests in development – Melanoma Dx, Lung Cancer Prognosis, and HRD Breast – are further along, while a Kidney Damage test is at a similar stage and nine other tests are behind in the pipeline.

Myriad estimates the annual market size for the hereditary cancer test to be $1.5 billion in the US and $5 billion globally, larger than for any other product in its molecular diagnostic pipeline.

The HCP test will likely compete with other NGS tests in development or on the market, for example, InVitae's test for 270 inherited conditions, including inherited cancers, which the company plans to launch this year (PGx 1/30/2012), or Ambry Genetics' Hereditary Cancer Panels.

Myriad currently offers nine diagnostic tests and had $149.1 million in total revenue in the first quarter, the lion's share from its BRACAnalysis test for inherited breast and ovarian cancer, which tests for mutations in the BRCA1 and BRCA2 genes and uses a combination of Sanger sequencing, PCR, quantitative PCR, and array CGH.

A company spokesperson declined to provide additional information on the HCP test, saying that Myriad plans to offer more details around the time of its investor day, which will be held May 9, in conjunction with its second-quarter earnings release.

It is unclear whether the HCP test will be Myriad's first next-gen sequencing-based test. A year ago, the company said it has several NGS tests in its pipeline, including the hereditary cancer test, a colon cancer test, and a tissue-based BRCA test that will be optimized for FFPE tumor samples (CSN 1/4/2012).

As of last summer, Myriad was equipped with several Illumina HiSeq and MiSeq instruments, several Roche 454 sequencers, and was considering Life Technologies' Ion Torrent platforms. A spokesperson said at the time that Illumina's HiSeq 2500 could "potentially" satisfy Myriad's requirements for accuracy, cost, and turnaround time.

However, Gary King, Myriad's executive vice president of international operations, added that the company had "found nothing that's as accurate, as fast, and as reliable as Sanger sequencing" yet (CSN 8/11/2012).

Besides exploring different next-gen sequencing platforms, Myriad has evaluated several DNA capture or enrichment technologies for its HCP test and chose RainDance's ThunderStorm system because it offered "the most automated and affordable solution for large volume genetic testing," according to the company.

Specifically, the ThunderStorm, which can analyze up to 20,000 genomic regions and process up to 96 samples in parallel, affords "unparalleled genomic coverage, the ability to detect large gene rearrangements, workflow benefits, and a favorable cost profile, all of which have been critical in overcoming the challenges associated with creating content- rich next-generation sequencing gene panels suitable for a high-throughput commercial laboratory," Myriad's Capone said in the statement.

The supply agreement demonstrates RainDance's ability "to scale up to the quality and volume of a major commercial laboratory of Myriad's scale," CEO Roopom Banerjee told Clinical Sequencing News. "It obviously gives us a very large commercial base upon which to grow our business with a single customer."

Under the agreement, RainDance will provide Myriad with ThunderStorm systems, reagents, gene panels, and consumables but the companies did not disclose financial terms of the agreement.

RainDance sells two platforms, the ThunderStorm and the RDT 1000, both of which use its microdroplet PCR technology. It has more than 70 "major translational, clinical genetics, and commercial testing labs" as customers, Banerjee said.

Among them are more than 20 customers that use RainDance as part of a laboratory-developed diagnostic next-gen sequencing test, such as Ambry Genetics, GeneDx, Emory Genetics Laboratory, Baylor College of Medicine, and Munich Leukemia Laboratory.

Those tests include some for inherited diseases and others for cancer, including several types of inherited cancers. "Whether or not those overlap with the exact areas that Myriad is working on, we are not able to disclose at this time," Banerjee said.

He said Myriad started working with RainDance several years ago, working with both the lower-throughput RDT 1000 and the higher-throughput ThunderStorm, but he did not disclose how many systems Myriad has currently installed.

He also did not comment on whether Myriad plans to use the ThunderStorm for other next-gen sequencing tests, "but the potential is there, given their pipeline, and as they expand their suite of next-gen sequencing applications."

RainDance's technology can be used with any sequencing platform, a potential advantage for Myriad, allowing it to switch sequencing platforms in the future if needed, Banerjee said. As an example, he pointed to Illumina's recent acquisition of non-invasive prenatal testing company Verinata Health, which turned Illumina into a competitor to several of its customers that use its sequencing platform. "Being able to separate the proprietary content from the commoditizing sequencing platform is a true advantage to many of these large commercial labs," Banerjee said.

While Myriad may optimize the ThunderStorm for a particular sequencing platform, "our technology is platform-agnostic and will support whatever sequencing platform our customers decide to select," he said.

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