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As Novartis Prenatal Pact Ends, Fluidigm Offers IP to Others, Continues Single-Cell Genomics Push


Just ahead of announcing its first-quarter financial results, Fluidigm this week disclosed the end of one partnership and the beginning of another, with the net result being a de-emphasis of its digital PCR technology for molecular diagnostics and a continued emphasis on single-cell genomics research.

Earlier this week, Fluidigm said that it and Novartis Vaccines and Diagnostics would not continue a collaboration begun in 2010 exploring the use of Fluidigm's integrated fluidic circuit technology for digital PCR-based, non-invasive prenatal diagnostics, particularly fetal aneuploidies.

The company will not continue to actively pursue similar applications for its technology in the near term, instead continuing its recent focus on single-cell genomics, which spokesperson Howard High said this week represented the company's "most important emerging market opportunity, without question."

Underscoring that notion, Fluidigm also yesterday announced that it has partnered with the Broad Institute to launch a new research center dedicated to mammalian single-cell genomics.

Fluidigm began its collaboration with Novartis in May 2010, but officially disclosed the partnership in December as it prepared for its IPO (PCR Insider, 12/9/2010).

The deal provided Novartis with an option to exclusively license Fluidigm's technology in the primary field of non-invasive testing for fetal aneuploidies and the secondary field of non-invasive testing of genetic abnormality, disease, or condition in a fetus or in a pregnant woman; RhD genotyping or carrier status in a pregnant woman; and the genetic carrier status of a prospective mother and her male partner.

Further, the agreements stipulated that except with Novartis, Fluidigm could not use, develop, or sell any products or services in those primary or secondary fields, other than for research applications in the secondary field.

However, this week Fluidigm noted in a filing with the US Securities and Exchange Commission that it "successfully achieved all of our technical feasibility milestones, completed the first phase of the collaboration plan, and received all milestone payments … however, the collaboration will not proceed to the next phase" as Novartis did not exercise its option prior to the option term date.

It is unclear whether Novartis will continue to pursue prenatal diagnostics using another technology platform or if it is continuing to explore the market at all. The company was unable to comment prior to publication of this article.

Fluidigm's High told PCR Insider this week that although he could not speak for Novartis, Fluidigm still believes that its technology, which enables multiple samples to be partitioned into tens of thousands of individual PCR reactions in order to detect rare genetic events, is "very applicable" to prenatal diagnostics and non-invasive genetic analysis, in general.

"We're certainly aware of companies like Sequenom … that are actively pursuing the non-invasive prenatal space right now, and enjoying good success," High said. "We really think this whole space and market is a significant one."

"But is that something that is an immediate impact to our company? Probably not, because we would still have to go through the various reviews and [regulatory] approvals … but we may come back and address [diagnostics] in the future."

In fact, High noted, one of the silver linings of the Novartis collaboration was that it helped Fluidigm better understand the various hurdles involved in clinical diagnostics development, should it eventually choose to re-enter the space.

"When this started in 2010, Fluidigm was still a private company, and because we hadn't been successful in our 2008 IPO bid [and] were in the throes of the great recession … having an agreement with a company like Novartis was a great opportunity in the sense that we gained a revenue stream as we met the milestones of the agreement," High said. "We also got to move our technology forward in the prenatal diagnostics space, and learn a bit about the whole regulatory environment around that space. So we developed our product line, we gained the revenue stream, and all of that was good."

This is not to say that Fluidigm is scrapping the idea of clinical diagnostics entirely in the near term, as the company noted in a statement that "it can now offer unrestricted sales of its digital PCR and other advanced technology to customers interested in pursuing research and product development into the prenatal health and non-invasive prenatal diagnostics fields, as well as other fields."

Until the Novartis agreement, Fluidigm had sold its products primarily for biomedical research applications such as gene expression analysis and targeted resequencing. However, High said that a number of its customers were interested in exploring its products for various non-invasive genetic testing applications, including prenatal diagnostics.

"Our ability to sell into this prenatal market was an increasingly important opportunity that we were having difficulties with," High said. But, because of the deal with Novartis, "some of our customers were nervous that they would come up against legal problems if they were in that space," High said. "They felt the risk was too great and they had to … look for other options to meet their needs."

As such, Fluidigm did lose some sales to customers interested in these markets. "On the flip side, we gained some revenue from Novartis as we met the milestones, so there's good and bad with everything," High said.

Now, however, customers are free to use Fluidigm's platforms for not just prenatal diagnostics, but any sort of non-invasive testing of genetic abnormalities — "in a fetus, a pregnant woman, to assess carrier status of a prospective parent," High said.

"As a variety of companies are looking to try and service the prenatal health and prenatal diagnostic area, that's a significant market opportunity for us," he added.

One Cell at a Time

Internally, Fluidigm will continue to focus its efforts on single-cell genomics, an emerging market that the company has been trumpeting as a core revenue driver for its products for the foreseeable future.

In fact, in February the company noted that single-cell genomics continued to drive sales of its BioMark HD platform, with approximately 45 percent of BioMark HD systems sold in the fourth quarter of 2011 designated for that application. Further, single-cell genomics revenues grew essentially evenly between BioMark HD instruments and the company's consumable chips (PCR Insider, 2/16/2012).

"This is a place where we can grow and sell right now," High said. "We're trying to focus as much attention and energy in that emerging single-cell market and capture that."

To that end, Fluidigm said in August that it was working with Becton Dickinson to co-host a series of public seminars on isolating and analyzing single cells using a combination of fluorescence-activated cell sorting and Fluidigm's digital PCR technologies.

And this week, following the announcement of its discontinued Novartis partnership, Fluidigm said that it was launching a mammalian single-cell genomics center at the Broad Institute's main building in Cambridge, Mass.

Fluidigm said that the center is expected to be a hub for collaboration among single-cell genomics researchers in a variety of fields, including stem cells and cancer biology; and that it will feature a "complete suite of Fluidigm single-cell tools, protocols, and technologies," most notably the BioMark HD System.

The center grew out of ongoing collaborations between the Broad Institute and Fluidigm bridging multiple genomic platforms.

"If you fast forward to where Fluidigm is today, fortunately now we were successful at our IPO in 2010. We have good capitalization, we are a more mature company with a thriving product line and some growing market segments such as single-cell genomics," High said. "So we have opportunities that we are actively working to seize, and products we are developing to service those market needs."