This story was first posted on Feb. 4.
Roche NimbleGen later this year plans to debut higher-density chips for use in cytogenetics research.
The firm disclosed last week that in the second half of 2011 it plans to double the density of its arrays for comparative genomic hybridization to 4.2 million markers, and will also introduce combined CGH/SNP arrays containing 2.1 million markers.
Roche discussed the pending product launches during a presentation of its 2010 annual results.
Roche NimbleGen's HD2 platform currently offers users the ability to survey up to 2.1 million markers per chip. In the past the company has not offered its clients the ability to look at SNPs.
Both upgrades will likely aid the Madison, Wis.-based firm as it competes against other big cyto research vendors like Agilent Technologies, Affymetrix, and Illumina. The ability to offer both CGH and SNP content in a single chip may equalize Roche's advantage over these rivals.
While widely adopted by geneticists for identifying the causes of constitutional abnormalities, CGH arrays are still unable to detect conditions like uniparental disomy or copy-neutral loss of heterozygosity, while SNP chips can.
The issue has prompted some geneticists to rely on SNP chips sold by other vendors, like Affy and Illumina. Agilent began offering CGH and SNP content last year to overcome this shortcoming (BAN 9/14/2010).
All four big array vendors are in discussions with the US Food and Drug Administration concerning submission of their cytogenetics-themed products for clearance. Roche said this week that it has filed a pre-investigational device submission for NimbleGen’s microarray platform with the FDA.
The firm sees such clearance as a gateway for greater revenue because it "could spearhead a product transition into IVDs, currently under development, to demonstrate their medical value and diagnostic utility," it noted in its annual report.
Roche NimbleGen CEO Frank Pitzer told BioArray News in July that, beyond constitutional genetic testing, the company envisions its arrays being used in other diagnostic markets, such as oncology (BAN 7/20/2010).
In November, it partnered with Beijing-based CapitalBio to help prepare its platform for routine diagnostic use (BAN 11/16/2010).
In its 2010 annual report, Roche cited its CGH arrays as a growth contributor during the year. While the company did not provide specific sales numbers for Roche NimbleGen, which is part of the Applied Sciences business area within its Diagnostics unit, it did report that sales of arrays and sequencing increased 17 percent in 2010 compared to the prior year.
The company attributed the spike in sales to "strong worldwide demand" for its benchtop GS Junior DNA sequencer, which it launched in May 2010.
Overall, Roche's Applied Science business area, which includes its arrays and sequencing businesses, reported CHF 868 million ($917 million) in sales, which was flat compared to 2009 but represented a 4 percent year-over-year increase in local currencies.
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