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cytogenetics

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.

According to attendees of an International Standard Cytogenomic Array Consortium workshop last week, standardizing the way in which array results are interpreted is the major task facing the space.

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.

"Cytogenetics is one of the first areas where there is interest to move beyond the current research studies, which will require an FDA cleared or approved product," said a Roche NimbleGen official.

The company also plans to seek FDA clearance for a cytogenetics device.

The agency could decide that array-based cytogenetic assays require 510(k) clearance or pre-market approval, a shift that could have a broad impact on the use of arrays in clinical cytogenetics.

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