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RainDance Eyes Early 2012 for Digital PCR Launch; Preps New Sequence Enrichment Platform for ASHG

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By Ben Butkus

RainDance Technologies President and CEO Roopom Banerjee this week provided an update on the company's timeline for its planned foray into the digital PCR space and disclosed that its forthcoming platform may be as much as 10 times more sensitive than originally estimated.

In addition, Banerjee updated investors on RainDance's near-term product commercialization efforts in the areas of sequence enrichment, targeted resequencing, and single-cell genomics; and reiterated RainDance's interest in the diagnostics arena.

Speaking at the UBS Global Life Sciences Conference in New York, Banerjee told investors that RainDance expects to launch a digital PCR instrument platform driven by its picoliter-volume droplet technology in "early 2012," most likely around the time of the American Association of Cancer Research meeting in early April.

Banerjee also said that the company will likely be previewing the digital PCR platform and publicizing some early data from experiments conducted with it at the Association of Molecular Pathologists meeting in November.

Since it was founded in 2004, Lexington, Mass.-based RainDance has primarily targeted the sequence enrichment and targeted resequencing space with its technology, which has the ability to create discrete picoliter-volume droplets containing individual molecules and PCR reactions at a rate of 10 million per hour.

However, in an interview with PCR Insider last July, Banerjee intimated that the same technology would enable unprecedented throughput and sensitivity for digital PCR applications such as rare mutation detection, single-cell gene expression, and rare event detection; and that RainDance was actively eyeing the space (PCR Insider, 7/8/10).

Then, the company confirmed that it was developing a digital PCR platform when it closed a $37.5 million Series D financing round in January (PCR Insider, 1/27/11). At that time, Banerjee said that the company hoped to be taking pre-orders for a digital PCR platform by the end of this year, but his comments this week suggest that timeline has now been delayed by a few months.

Once it is launched, the platform should exceed initial expectations in terms of throughput and sensitivity: Whereas RainDance originally estimated that its platform would be able to generate approximately 1 million data points per sample, it now believes that figure will be closer to 10 million data points per sample due to some "technological breakthroughs" to elements such as optical labeling technology and multiplexing capabilities, Banerjee said.

"In order to be successful, digital PCR must have a maximum number of data points per sample, it must be multiplexed, and it must be able to be scaled up," Banerjee said, all characteristics enabled by RainDance's technology.

The end result for an application such as mutation detection is that "while our competitors struggle to see one in 5,000 mutations, we will have one in 100,000 to 200,000 right out of the gate," Banerjee said. "We also have the ability to multiplex, and to do single-cell or single-molecule genomics." Competing digital PCR platforms in order from first on the market to most recent include Fluidigm's BioMark HD, Life Technologies' OpenArray platform, and QuantaLife's Droplet Digital system.

Researchers from RainDance and partnering academic institutions demonstrated the multiplexing capability of the RainDance digital PCR technology in a pair of scientific publications in May, papers that also exemplified how the technology might be used in clinical diagnostics (PCR Insider, 5/26/11).

Still, the newness of RainDance's technology presents the company with the challenge of explaining to potential customers exactly how its platform will work and what new applications it might enable, just as Banerjee found himself explaining these items to investors at the UBS conference.

When questioned by once conference attendee about how RainDance expects to detect single positive reactions in a sea of millions of picoliter droplet reaction chambers, Banerjee pointed again to the company's proprietary optical labeling technology, which he said makes "a single fluorophore in a droplet look as bright as the sun. It's so simple to call a positive."

Questions still abound about the digital PCR intellectual property landscape, which Banerjee himself called "thorny" last summer. Life Tech has made some early claims on microdroplet biology IP acquired along with Stokes Bio; and a license to some of RainDance's core IP obtained from Lawrence Livermore National Laboratory is shared with competitor QuantaLife.

But Banerjee assured investors at UBS that the company "would not be doing this if we didn't have a high degree of confidence in our freedom to operate."

Lastly, investors asked Banerjee whether he could foresee the company developing its own assay content for digital PCR applications or applying the technique for molecular diagnostics purposes. To the former, Banerjee said that it could happen "down the road;" and to the latter, he said that the company already has "two unannounced partnerships with diagnostic companies that will help achieve that."

ThunderStorm Brewing

In other news, Banerjee said that RainDance will unveil its newest instrument platform for sequence enrichment, the ThunderStorm, at the American Society of Human Genetics meeting next month in Montreal.

ThunderStorm is a "fully automated, walkaway system for single-cell sequence enrichment and targeted resequencing," Banerjee said, adding that it is basically a much higher throughput version of the company's current flagship RDT 1000 sequence enrichment platform, with the ability to process 96 samples per day.

According to Banerjee, ThunderStorm will be able to complete a targeted resequencing protocol in about 15 minutes with no hands-on time as compared to the several days it takes competing platforms. He also said that the instrument will enable RainDance to offer sequence enrichment protocols at a price of between $100 and $150 per sample, primarily due to "the success of the Sony DADC Blu-Ray technology" that RainDance announced it had incorporated into its consumable products in June after finishing a two-year collaboration with the consumer electronics firm.

Banerjee said that it expects that "all of RainDance's sequencing applications will run on [ThunderStorm] in the future."

Separate from Banerjee's presentation at UBS, RainDance said this week that Ambry Genetics would be one of the first ThunderStorm customers and would offer genetic testing and next-generation targeted sequencing services on the platform once it is launched.

ThunderStorm is "a true game changer both in terms of processing speed and data quality, and we look forward to rolling out a portfolio of services based on this technology platform to our customers," Ardy Arianpour, vice president of business development at Ambry Genetics, said in a statement.


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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