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NanoString Establishes Dx Unit as Breast Cancer Test Moves Closer to FDA Submission

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NanoString Technologies this week took another step toward commercializing its Breast Cancer Intrinsic Subtyping Assay for clinical use by establishing a new diagnostics business unit to focus on selling the test, while moving sales of its research products to its newly named life sciences unit.

NanoString also said this week that it has hired Bruce Seeley to lead the new diagnostics unit. In his position as senior vice president and general manager of diagnostics, Seeley will oversee the marketing of NanoString's breast cancer test to pathologists and oncologists.

"We are building from scratch a new business," NanoString CEO Brad Gray told BioArray News this week. Gray said that "everything" that NanoString has done to date has been focused on research, but that entering the molecular diagnostics market required a separate team.

"The customer set is so different, and it's a regulated business that moves at a different cadence" from life sciences research, Gray said. He said that Seattle-based NanoString is now looking to fill out its diagnostics unit with medical industry veterans, and that the customer focus will be on "oncologists, pathologists, and clinical laboratories."

Privately held NanoString launched its first-generation nCounter Analysis System in 2008 and has since introduced applications for gene expression, microRNA analysis, and copy number variation. The company introduced a smaller, benchtop system last year (BAN 10/18/2011). Using the nCounter, researchers can measure expression or copy number using sets of color-coded molecular barcodes and single-molecule imaging.

The company's breast cancer assay is based on PAM50, a gene signature that it exclusively licensed last year from Bioclassifier, a consortium of academic cancer experts. PAM50 can be used to estimate the prognosis of postmenopausal women with hormone receptor-positive early-stage breast cancer, the firm claims.

NanoString presented the results of a first clinical validation study in December at the San Antonio Breast Cancer Symposium (BAN 11/08/2011). Earlier this month, NanoString said it had initiated a second clinical validation study that will evaluate samples from more than 1,000 patients enrolled in the Austrian Breast & Colorectal Cancer Study Group 8 trial

Gray said that the company will likely present results of this second study at a "major cancer meeting" within the next 12 months. Moreover, he said the two validation studies will form the basis of a submission of the test to the US Food and Drug Administration, though he declined to provide a date for when that might happen. "Our objective is, as soon as we can do so, to begin commercial sale of this test," he said.

Gray called Seeley a "nontraditional hire," as his background is in therapeutics. Seeley previously worked at Seattle Genetics, where he helped launch a therapy for lymphoma called Adcetris. Prior to that, he helped lead the launch of Herceptin at Genentech. Seeley said he is unsure of how large NanoString's diagnostics team will need to be to address the market, citing a host of issues that require assessment, such as the reimbursement environment.

NanoString's breast cancer test will not be the only diagnostic to run on its platform. Though he declined to go into detail, Gray said that 60 percent of NanoString's customers are academics involved in cancer research. He said that NanoString maintains an "active dialogue" with its customers concerning potential diagnostic signatures.

Life Sciences Update

While NanoString builds its diagnostics business, it hasn't taken its eye off life sciences research. The firm continues to compete in a number of markets currently dominated by microarray vendors.

Specifically, earlier this year, NanoString introduced its Plex2 Expression Assay Kit, which allows nCounter users to measure up to 200 targets in up to four samples in a single tube; its Cancer Copy Number Assay Kit, which supports the analysis of 86 genes that are commonly amplified or deleted in many cancer types; and its Human v2 miRNA Expression Assay Kit, which allows investigators to profile 800 of the most highly expressed miRNAs in a single tube without the need for amplification.

Of the latter assay, the company said in a statement at the time that it offers "superior specificity and sensitivity at a lower cost than microarrays and next-generation sequencing."

Gray said the firm has seen a "positive response" to the assays, and that all three are "geared to oncology researchers." The company's miRNA assay — which faces off against a host of companies, including Affymetrix, Illumina, Agilent Technologies, and Exiqon —is actually NanoString's "most popular" product, Gray said.

"It's a very important part of our business, growing robustly since we launched it in spring 2010," he said.

And while some array firms, notably Affy, have seen expression array sales slip due to the migration of users to next-generation sequencing-based approaches, NanoString has "not felt an erosion of its business due to RNA-seq," Gray said.

Rather, he sees customers adopting nCounter to validate signatures identified by NGS, as both approaches are digital, as opposed to fluorescence-based array technologies. Instead, the company is more eager to convert users of quantitative PCR to its platform, he said.

Having raised funds several times in the past few years — including a $15 million round of debt financing last month and the closure of a $20 million series D round last November — Gray said the firm is investing in life science research by "trying to drive the performance up and the cost down." To that end, last month it announced the hire of Joseph Beechem, a former Life Technologies executive with a background in sequencing, as senior vice president of R&D.

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