The approval, announced in an FDA statement on Dec. 23, marks the first time that a DNA chip reader has won FDA clearance for IVD use. The agency also said the clearance may open the door for additional molecular diagnostics based on microarrays to be sold nationwide.
The chip and its reader were approved for sale in the European Union in September.
"The FDA's decision is another milestone demonstrating Affymetrix' commitment to clinical diagnostic products," Stephen Fodor, chairman and CEO of Affymetrix, said in a statement today.
As GenomeWeb News reported earlier this month, Affy and Roche had separately filed with the FDA their AmpliChip products. A Roche spokesperson told GenomeWeb News at the time that the company is "hoping to see [FDA] clearance [of the Affy reader] in 2005." He did not comment on when Roche expects the AmpliChip to be cleared.
"Physicians can use the genetic information from this test to prevent harmful drug interactions and to assure drugs are used optimally, which in some cases will enable patients to avoid less effective or potentially harmful treatment choices," Lester Crawford, acting FDA commissioner, said in the agency's statement.
The FDA said that the AmpliChip "is the first DNA microarray test to be cleared by the FDA and its clearance paves the way for similar microarray-based diagnostic tests to be developed in the future."