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WaferGen Signs on Two Additional Early-Access Partners for Single-Cell Analysis Tech


NEW YORK (GenomeWeb) – WaferGen Biosystems this week announced that it has signed on two additional early-access partners for its SmartChip-based single-cell analysis technology, laying the groundwork for a planned 2015 launch of what the company sees as the primary driver of its future growth.

At the same time, the firm is developing a commercialization strategy for the new technology — an effort being overseen by newly appointed President and CEO Rolland Carlson — as it gears up to go head-to-head with top competitor Fluidigm for a share of a market estimated to be worth as much as $600 million.

As new data points to the existence of heterogeneity among individual cells of the same population, "single-cell analysis has become increasingly important for scientists attempting to unlock the underlying mechanisms of complex diseases," WaferGen Executive Chairman Ivan Trifunovich said during a conference call held this week to discuss the firm's first quarter financial results. As such, "both government and private institutions have committed significant investments toward single-cell basic and clinical research."

To date, he said, only Fluidigm offers a fully integrated solution for single-cell genomics research with its C1 system, resulting in a "$600 million market with a limited competitive landscape." And although Fluidigm may have been first to market, Trifunovich said that the higher-throughput of WaferGen's single-cell analysis platform gives it a significant advantage.

The C1 system is designed to automatically isolate and prepare up to 96 cells for qPCR or sequencing analysis. Fluidigm's upcoming Polaris system for single-cell assays and sample prep, meanwhile, is designed to select and capture 48 cells, while a soon-to-be released microfluidic chip for high-throughput mRNA-seq prep on the C1 system is designed for up to 800 single cells.

In comparison, WaferGen's system uses a 5,184-well chip. With an expected 80 percent yield, "we are shooting for 4,000-plus cells," he said. "That's the game-changing aspect of our product … especially for pharmaceutical companies that need to look at thousands of cells as opposed to a few dozen cells."

"There is an unmet need that Fluidigm cannot fulfill," Trifunovich added. "We feel we can do that."

After completing proof-of-concept work on the single-cell analysis technology with the Broad Institute and BGI, earlier this year WaferGen kicked off an early-access program for its SmartChip single-cell analysis technology to make sure it is ready for launch before year-end, and last month it announced that Roche subsidiary Genentech had signed on as the first early-access participant.

This week, WaferGen said that National Jewish Hospital and Sweden's Karolinska Institute have also joined the program. Notably, National Jewish Hospital will be testing the single-cell analysis technology for diagnostic use in asthma and pulmonary disease, with WaferGen holding the right of first refusal for any clinical biomarkers resulting from that work, Trifunovich said during the call.

He added that WaferGen expects to add one or two more early-access partners, but intends to be selective in its choices. "We don't want to sign everybody who shows up," he said, noting that "we have more people rais[ing] their hands than we have slots."

As early-access partners help put the finishing touches on the single-cell technology, WaferGen is also defining a strategy for commercializing it, with Carlson taking the lead as he leverages his past experience as President and CEO of privately held molecular diagnostics firm Asuragen.

Given that Carlson is still transitioning into his new role, WaferGen has not finalized a business plan for its new technology, but Trifunovich said that it is considering both building out its own sales force and finding a partner to sell products "in certain markets and through certain channels."

As for the market segments it aims to address, he said that its initial customers would be the same that Fluidigm currently sells to, including both academic and pharmaceutical industry researchers.

"As we go forward, we'll have to see how much of a clinical angle there will be with single-cell" analysis, he added. "To my knowledge, there are no approved clinical tests that are utilizing single-cell technology at the moment, but that could change as people like National Jewish Hospital come up with content."