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As RainDance Center of Excellence, RUCDR to Offer dPCR, Mutation Analysis to Academia, Pharma


NEW YORK (GenomeWeb) — RUCDR Infinite Biologics, the research services and biorepository arm of the Rutgers University Cell and DNA Repository (RUCDR), has been named a RainDance Technologies Center of Excellence, the partners said this week.

The partnership is expected to benefit RainDance by enabling RUCDR Infinite Biologics' clients in both academia and pharma to develop new applications for RainDance's picodroplet-based digital PCR platform, RainDrop, as well as its ThunderBolts Cancer Panel for targeted sequencing and profiling of cancer mutations.

Meantime, RainDance's products enable RUCDR to conduct rapid and cost-effective profiling of tumor samples stored in its biorepository, and allow RUCDR Infinite Biologics to support biomarker discovery and companion diagnostic development for its valuable pharmaceutical and biotech customers, RUCDR Infinite Biologics Chief Operating Officer Andrew Brooks told PCR Insider.

"This is a partnership … [and] part of a program that [RainDance is] looking to expand so that they can work with academic labs and service organizations that will … champion new applications for the technology," Brooks said. "Given that we are as much an academic facility as a service organization, this helps not only validate the existing technologies, but transition [them] and make them more globally available."

RUCDR Infinite Biologics is a service organization that is run out of Rutgers University's Human Genetics Institute, but is independent of the school. Currently, RUCDR Infinite Biologics is the federal biorepository for four National Institutes of Health institutes.

"We do work with literally hundreds of investigators that are funded through NIH for genetics and biobanking work," Brooks explained. In addition, the organization has partnered with BioStorage Technologies to create a private sector business called the BioProcessing Solutions Alliance, which uses essentially the same infrastructure to offer these types of services to pharma and biotech customers.

"So that is also a component of this [RainDance] Center of Excellence, that we have broad reach in academia and industry to kind of identify those applications and vet them with new technologies," Brooks said.

A RainDance spokesperson told PCR Insider in an email that aspects of the partnership call for the RUCDR team to act as a "reference and best practices demonstration site" and provide fee-based lab services to cancer researchers and collaborators who wish to run studies at RUCDR using RainDance's platform, of which RUCDR has several.

"In exchange, RainDance will collaborate with RUCDR for scientific validation studies and for the development of novel genomic content and applications," the spokesperson said.

"For a lot of these new technologies, it's not even the cost of buying the box or the new technology, it's assessing its value for specific applications," Brooks added. "So this kind of center designation gives them the opportunity to partner not only with us in the development, but with other people who want to use and implement the technology to make it more successful."

Brooks said that a typical academic client of RUCDR Infinite Biologics or the BioProcessing Solutions Alliance would use the RainDance platform for research and discovery. "We provide all of the extraction and QC services. And then basically we would run ThunderBolts or digital PCR for them to make their assessments in a research-grade format. We provide the continuum of services from sample collection management and logistics all the way through to analysis."

Meantime, on the private sector side, all of the organization's services are "highly regulated," Brooks said. "It's possible that as part of a clinical trial, one of our pharmaceutical clients … would want to generate variant data either as a part of companion diagnostic development, to find actionable markers that relates to their submission, or generate data on specific actionable genotypes as a part of their clinical trial."

Brooks underscored the fact that RainDance's technologies are all research use only, and as such, "anything we would potentially use in a clinical setting, which is really the goal here, would be validated independently through our laboratory-developed test process in our CLIA lab."

RainDance has developed several instrument platforms and applications around its proprietary picodroplet technology. The company's first products, the RDT 1000 and ThunderStorm, specifically addressed the targeted sequencing market. Meantime, in early 2012 RainDance began delivering its RainDrop digital PCR system to early access customers and began selling the platform last year.

In September, RainDance announced that it had closed a structured debt financing with Capital Royalty Partners, providing it with up to $35 million to support commercial expansion of both its digital PCR and targeted sequencing products. However, at the time, RainDance CEO Roopom Banerjee told PCR Insider that the financing would particularly support the company's burgeoning digital PCR business, which RainDance expects to equal or eclipse its targeted sequencing business by the end of this year.

In general, all of RainDance's products are powered by the picodroplet technology, which provides high levels of sensitivity and speed, and low cost per sample compared to competing products. These characteristics also made the platform attractive to RUCDR Infinite Biologics and its clients.

"[For] digital PCR, it's in a class by itself," Brooks said. "The only other digital PCR applications that we were running previously were with Fluidigm. But their technology has limitations associated with the number of reactions you can do per sample. For digital PCR, it's not that we were unhappy with what we were using; it's just that this gives us a level of sensitivity that we could not achieve before."

Meantime, for targeted sequencing and enrichment applications, RUCDR supports a number of technologies, Brooks said.

"For targeted sequencing, we were previously running largely AmpliSeq from [Thermo Fisher Scientific's] Ion Torrent," he said. "Here the issue was the process, the emulsion PCR, the instrumentation that Ion offered, leading to a lot of variability. And they're still working and trying to improve that."

The advantage of ThunderBolts, he added, "is not so much what we get out of sequence quality … but it's the process. Here the process is extremely simple and is very robust. So it's a combination of how the technology works and the sensitivity, which makes it unique."

Another attractive feature of RainDance's droplet-based applications is that they can all be run on essentially the same instrument platform — including quantitation and quality scoring of samples using RainDrop digital PCR; profiling incoming samples for primary tumor mutations using ThunderBolts; and subsequent validation of important driver mutations using RainDrop again, RainDance's spokesperson noted.

"The advantage that we see in having multiple applications for a single technology is standardization," Brooks added. "It's the same platform, but with a number of different applications, which really is most efficient and maximizing sensitivity."