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NanoString to Launch New Expression Assays; CEO Dishes on Dx Strategy

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This story has been updated from a previous version to include information about a competitive offering.

By Justin Petrone

NanoString Technologies will next month introduce a new assay that can profile mRNA and microRNA expression at the same time, according to its CEO.

Brad Gray told BioArray News that the Seattle-based company will launch a custom codeset offering for mRNA and miRNA expression profiling in September. The offering will debut on the heels of its recently launched rat miRNA panel, and is part of the company's effort to expand its gene-expression menu.

Gray also discussed the company's diagnostics strategy, and said that NanoString has commenced a clinical study of its breast cancer prognostic, and is already communicating with the US Food and Drug Administration about the appropriate path forward for the test.

According to Gray, once launched, the mRNA/miRNA panel will make NanoString the "only firm in the market" to offer mRNA and miRNA expression in the same assay. Most microarray firms sell separate arrays for gene- and microRNA-expression profiling.

At least one firm, HTG Molecular Diagnostics, has a similar offering. The company has allowed users the ability to survey mRNA and miRNAs in the same assay on its qNPA ArrayPlate System since 2008.

Still, Chris Grimley, NanoString's vice president of marketing, claimed last week that "all of our competitors require users to do mRNA and miRNA assays separately." He told BioArray News that the firm's customers will soon be able to select mRNA and miRNA targets of interest, and receive back a custom codeset that will allow users to assay all the markers at the same time.

"Customers have expressed an interest in this capability, and it is an interesting development on our side," Grimley said. He declined to discuss the new assay in detail, but said that NanoString is using a workflow similar to its miRNA workflow to be able to enable mRNA and miRNA expression profiling at once.

"It is facilitated by the fact that we have an enzyme-free expression technology," Grimley noted. "We directly detect targets, we don't amplify. That allows us to combine the workflows."

When asked how the codesets will compare against microarray technology, Grimley stressed that NanoString "resides in the validation space." The main discovery tools "will continue to be microarrays and RNA-seq," Grimley said.

NanoString was founded in 2003. Its nCounter Analysis System was developed on technology licensed from the Institute for Systems Biology and enables researchers to measure gene expression in a multiplexed fashion using sets of color-coded molecular barcodes and single-molecule imaging to detect and count hundreds of unique transcripts in a single reaction.

The firm has launched a number of expression-focused products, most recently a panel for rat miRNA profiling. The company launched human and mouse miRNA panels last year.

The nCounter Rat miRNA Expression Assay Kit provides the capacity to perform multiplexed profiling of more than 400 rat miRNAs in a single tube and is compatible with multiple sample types, including formalin-fixed, paraffin-embedded samples, according to a statement from the firm.

"We now cover all the major species for miRNA," said Grimley. "We are really building a strong portfolio in expression in general." According to Grimley, the new panel should make the company competitive against array firms that sell miRNA chips, such as Agilent Technologies, Affymetrix, Exiqon, and Illumina.

"I think our performance is better than microarrays and we offer higher resolution," he said.

'Taking the High Road'

While NanoString builds its research offering, it is also branching out toward the clinic.

The company announced in December 2010 that it had secured from Bioclassifier, a consortium of cancer experts from four institutions, an exclusive worldwide license for the PAM50 gene signature to develop breast cancer-related in vitro diagnostic and research products.

NanoString subsequently made the signature available for research purposes with an eye toward submitting the test, called the Breast Cancer Intrinsic Subtyping Assay, for FDA approval within the following few years (BAN 12/7/2010).

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NanoString announced earlier this month that it had initiated the first in a series of studies to evaluate the clinical utility of the assay. The initial investigation will rely on approximately 1,000 samples from the TransATAC study to evaluate whether the assay can quantitate the probability of cancer recurrence in individual post-menopausal women with hormone receptor-positive, early stage breast cancer who have been treated with hormonal therapy.

TransATAC is a translational study group that has used the tissue and data from the Arimidex, Tamoxifen, Alone or in Combination trial to study the molecular characteristics of tumors in patients with ESBC. Mitch Dowsett, head of the academic department of biochemistry at the Royal Marsden NHS Trust in the UK, is a member of the TransATAC study group and the lead investigator collaborating with NanoString on the study.

While the company moves ahead with the trial, it is also discussing with FDA the path forward for the test, according to Gray. He said that Agendia's MammaPrint test, a microarray-based breast cancer prognostic that received premarket approval from the agency in 2007, is a "possible predicate" for NanoString.

He also said that submitting the assay for 510(k) clearance, as Roche and Affymetrix did in 2004 for the AmpliChip CYP450, is also possible.

"It's just too early to say," Gray said of the process by which the test would be submitted for clearance. He also declined to discuss a timeline for when the company would submit it for FDA review.

Overall though, the company is committed to getting its platform cleared for diagnostic use.

"Our objective is to have our program as the premier platform for gene-expression diagnostics worldwide," said Gray.

He said that the firm will likely continue to focus on tests for cancer.

"There is plenty of work to do in oncology," said Gray. "Sixty percent of research being done on our system is focused on cancer, and clients are using our system to validate signatures identified in discovery." Such studies provide the firm with a "steady stream" of potential test content, he noted.

At the same time, NanoString will not make the nCounter system available for other companies or organizations as a technology platform for their own tests. Some tool vendors, such as Affymetrix and Luminex, have allowed other companies to commercialize tests based on their respective platforms. NanoString does not have similar plans.

"We like to control our destiny," said Gray of the firm's strategy. "That's the only way a company with a unique platform like ours can be certain that high-quality diagnostics are developed on its technology platform."

He said that to follow Affy and Luminex's example would be to "hope other people select good diagnostics" for NanoString's system. "And you collect a very small fraction of the value of the diagnostic," he noted.

"We are taking the high road, the expensive road, but it will have more benefits in the long run," he said.


Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com.

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