While the company's main customer group to date has been researchers conducting GWAS, it is targeting the latest version of its software to those using arrays in cytogenetics and agricultural biotechnology studies.
Roche NimbleGen CEO Frank Pitzer said recently that the firm intends to enter the diagnostics market, where it will develop "important, valuable applications," the first of which will be in the field of cytogenetics.
At a meeting hosted by the US Food and Drug Administration last week, FDA representatives made it clear that the agency will in the future require array manufacturers to seek clearance in order to sell their chips for use in clinical cytogenetics, though it has not yet reached a decision on what criteria it expects vendors to fulfill in order to achieve such clearance.
The company is preparing a third-generation cytogenetics offering that will expand upon the SNP content of its 6.0 genotyping array and the copy number variation content of its Whole-Genome 2.7M Array.
The decision of major array vendors to seek FDA clearance for their cytogenetic array platforms comes at a time when the agency has indicated that it could require labs that offer array-based chromosomal analyses to use cleared tests in the future.