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Approving Last of Two Genes, FDA Finally Clears Roche s AmpliChip as an IVD

NEW YORK, Jan. 11 (GenomeWeb News) - The US Food and Drug Administration has cleared the second of two genes in Roche Diagnostic's AmpliChip CYP450 test, clearing the way for the device to be sold as an in vitro diagnostic in the United States, the company said today.


The approval comes three weeks after the FDA cleared the first half of the product. The AmpliChip, based on Affymetrix's Gene Chip technology, comprises two genes in the CYP450 family: 2D6 and 2C19. As GenomeWeb News reported late last month, the FDA on Dec. 23 approved the 2D6 portion, but made no statement about the 2C19 gene.


The final approval means that physicians in the United States will now be able to prescribe the test, which could help them decide dosages for drug families such as anti-depressants, anti-psychotics, anti-arrhythmics, beta-blockers, analgesic, anti-emetics, cancer drugs, anti-convulsants, proton pump inhibitors, benzodiazepines, and anti-malarials.


The AmpliChip was approved for sale in the European Union in September.


"The use of this test is an important step forward in making personalized medicine a reality and has the potential to help physicians improve patient outcomes," Heino von Prondzynski, CEO of Roche Diagnostics, said in a statement.

According to Roche, multiple variations in the CYP2D6 gene can "result in poor, intermediate, extensive ("normal"), or ultra- rapid metabolism of CYP2D6-dependent drugs from a variety of classes," including anti-depressants, anti-psychotics, anti-arrhythmics, beta-blockers, analgesics, anti-emetics, and "some" anti-cancer drugs.


Variations in the CYP2C19 gene, meantime, "result in either normal or poor metabolism of CYP2C19-dependent drugs from a variety of classes, including anti-convulsants, proton pump inhibitors, benzodiazepines, and anti-malarials," the Swiss diagnostics giant said.

"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 an agency statement announcing the approval of the 2D6 portion last month.

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."

Affy's GeneChip System 3000Dx instrument, on which the AmpliChip CYP450 test is run, was cleared by the FDA on Dec. 23.

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