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NanoString Developing Benchtop nCounter System; Multianalyte, Protein Analysis Assays

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NanoString Technologies' increasingly diverse portfolio of molecular analysis products is set to expand in coming quarters.

On a recent earnings call, executives at the Seattle-based company discussed a number of internal R&D initiatives that are expected to yield new products, among them a benchtop version of its nCounter Analysis system, as well as multianalyte and protein analysis assays.

They also provided an update on the launch of NanoString's Elements general purpose reagents and the company's Prosigna Breast Cancer Assay.

While much of NanoString's focus in recent quarters has been devoted to the launches of Prosigna and Elements, instrument placements continue to be its primary growth driver. The firm now has an installed base of 180 instruments, each of which has an estimated annual consumable pull through of $100,000. As NanoString outlined on the call, instrument sales in the fourth quarter of 2013 more than doubled to $5.3 million, representing more than half of the $10.1 million in revenues the company reported for Q4.

NanoString's flagship instrument to date has been its nCounter Analysis System, but in November it launched nCounter Dx, which is intended for molecular diagnostics use, and can be configured to run research or diagnostic assays, depending on the intended use. CFO Jim Johnson said on the call that NanoString placed five Dx systems with dual use configurations in Q4.

According to CEO Brad Gray, NanoString is currently developing a benchtop version of the nCounter, which should launch by the end of 2014. Gray said that the firm was keeping details about the new instrument "close to the vest," but that the "technical improvements that are required to introduce the benchtop system are largely behind us," and the company is now dealing with engineering issues prior to the system's launch.

The company continues to invest in the new instrument. On the call, Johnson attributed a 33 percent jump in the company's R&D costs to the "design and engineering of our benchtop system." However, he declined to provide additional comment about the system on the call, citing competitive reasons and, when queried, a NanoString spokesperson similarly declined to elaborate.

Gray discussed the benchtop system in January at the JP Morgan Healthcare conference in San Francisco. He said that the new system would consolidate the separate sample prep and digital analyzer instruments that make up the current version of the nCounter into one box, and that the price of the benchtop system is anticipated to be between $75,000 and $125,000.

On the call, Gray said that NanoString is also developing a multianalyte assay based on new chemistry that will "substantially increase the specificity of our probes."

According to Gray, these developments open the door to future multianalyte assays, allowing the analysis of DNA markers, RNA and proteins in a single run. "This could increase the appeal of our technology in markets where we already compete and open up new markets like proteomics, which have not been targeted in the past," he said.

NanoString continues to develop a separate assay for multiplexed protein analysis on the nCounter. The company announced in January that it had secured an exclusive option from Massachusetts General Hospital to license IP related to an approach developed by Ralph Weissleder, director of the Center for Systems Biology at MGH, and other researchers.

Weissleder and colleagues linked antibodies to DNA barcodes, and then used NanoString's nCounter system to quantify levels of these DNA barcodes, which corresponded to the levels of target proteins. Using the approach, the team was able to analyze 90 proteins at single-cell sensitivity in breast and lung cancer samples. Their study was featured in a recent Science Translational Medicine paper.

Gray said that the introduction of NanoString's protein analysis assay is "several quarters away," and that the company is working with Weissleder and others at MGH to replicate the work and to simplify the assay before it is introduced as a product.

According to Gray, both the multianalyte and protein analysis assays could become available by the end of the year.

Elements launches

Last month, NanoString announced the commercial availability of nCounter Elements, general purpose reagents developed for translational research and clinical laboratories. The offering is based on the company's digital molecular barcoding chemistry and allows users to assemble their own customized assays using standard sets of barcodes provided by NanoString and probes that they can purchase independently from an oligonucleotide manufacturer. The firm began offering Elements through an early access program last summer.

On the call, Gray discussed the roll out of Elements, which he said should "appeal to both clinical labs looking to develop their own diagnostic tests, as well as translational researchers, who have been among our core customers in the past."

According to Gray, of the 22 early access Elements customers, two thirds were involved in translational and clinical research, and half of those were focused specifically on cancer. About a fourth of early access customers' projects were dedicated to investigating fusion genes, "indicating strong interest and the potential to use nCounter-based multiplex fusion assays as a replacement for single-plex assays based on fluorescence in situ hybridization," Gray said.

NanoString has said that Elements customers will likely move their research assays into clinical use at some point. Gray predicted that the first diagnostic testing services on Elements should emerge "at a slower pace in the next quarter or two, accelerating to the back half of the year."

The first impact of Elements may actually be felt in instrument placements, Gray said. He said that cancer centers in particular could be attracted to the nCounter Dx system because of its dual use configuration, which would allow them to run Prosigna in diagnostics mode, and develop new assays using Elements in life science research mode. "The first impact we are likely to feel from Elements is actually on our instrument revenue line," said Gray.

By offering Elements with Prosigna and the nCounter Dx, Gray said that NanoString is "uniquely positioned to offer local labs the opportunity to perform both translational research and complex high-value clinical testing for cancer." He added that NanoString "expects that the clinical laboratory market will continue to emerge as a major catalyst for growth during 2014."

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