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Planning FDA Submission for Cyto Arrays, Agilent Obtains ISO 13485 Certification

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By Justin Petrone

Agilent Technologies this week said its array manufacturing process has received ISO 13485 certification as part of its plan to submit its cytogenetic arrays for clearance with the US Food and Drug Administration.

Last year, Agilent's array manufacturing process was deemed to be compliant with the latest ISO 9001 standard set by the International Organization for Standardization, which provides general requirements for quality management systems. ISO 13485 is a standard for quality management systems for the design and manufacture of medical devices.

Gustavo Salem, vice president and general manager of Agilent's Biological Systems Division, said in a statement that the latest ISO certification puts the company in a "strong position" to pursue clearance for a cytogenetics device based on Agilent’s platform.

For years, Agilent has sold comparative genomic hybridization arrays that have been used for cytogenetic research purposes. Some labs, such as Baylor College of Medicine's Medical Genetics Laboratories and Emory Genetics Laboratory, use Agilent-made arrays in their cytogenetic services, while a number of companies, including Oxford, UK-based Oxford Gene Technology and Cambridge, UK-based BlueGnome, sell Agilent-manufactured chips specifically designed for the cytogenetic research market.

Agilent is the latest microarray vendor to say that it will seek FDA clearance for a cytogenetics kit. Illumina said in January that it plans to submit a cytogenetics package to the FDA that includes its arrays, iScan system, and software (see BAN 1/26/2010). Affymetrix has also said recently that it eventually plans to submit its cytogenetics offering to the agency (see BAN 2/9/2010).

The decision to seek FDA clearance for array-based cytogenetics offerings comes at a time when the agency is reviewing the way it regulates arrays used by Clinical Laboratory Improvement Acts-compliant cytogenetics labs (see BAN 10/13/2009).

Michael McNulty, senior director of clinical applications at Agilent Technologies, told BioArray News at the time that the FDA informed Agilent of its ongoing review last summer.

"We met with the FDA this summer to discuss the role of microarrays and genetic testing in clinical diagnostics," McNulty said at the time. "The FDA notified us they have determined that microarray-based assays … are medical devices. Being medical devices, the FDA will require CLIA laboratories to seek clearance for their assays."

A representative for the FDA's Office of In Vitro Diagnostics, which oversees the regulation of medical devices, told BioArray News at the time that the agency has been reviewing the use of the tests. She said that the laboratory-developed tests used in clinical cytogenetic labs have been offered so far under the "regulatory discretion" of the agency, but that OIVD is now "going through a process of review and discussion" that could result in increased regulation of the tests.

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