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Agendia MammaPrint Recall Completed

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This article has been corrected to note that FDA did not inspect Agendia's facilities. The MammaPrint recall was company initiated.

The US Food and Drug Administration last week informed Agendia that the agency had finished its audit of the firm's recall of faulty MammaPrint tests.

In a letter dated June 18, FDA wrote to Agendia that the recall has been completed and "there has been proper disposition of the recalled product."

Agendia initiated a voluntary field correction and recall of a batch of its MammaPrint tests at its Huntington Beach, Calif. facility on March 10. At the time, the company also informed FDA that the recall was needed since some MammaPrint breast cancer recurrence scores were over-reported due to a faulty batch of reagents from an undisclosed third-party provider (PGx Reporter 04/14/10).

After the FDA's audit of Agendia's recall, the agency reported that for six months 15 percent of results provided by Agendia "over-reported" the chance that a patient's breast cancer would metastasize. The faulty tests reported patients as having a 29 percent recurrence risk instead of a 10 percent risk.

Agendia finished the recall on April 6. FDA finalized the recall effectiveness check on June 18.

MammaPrint is a microarray-based diagnostic that determines breast cancer patients' risk of disease recurrence based on a 70-gene signature panel. The test identifies early-stage breast cancer patients as either being at low risk or at high risk of distant recurrence following surgery, independent estrogen receptor status, and any prior treatment.

If MammaPrint determines a patient is at low risk of recurrence, then she may be given tamoxifen to further reduce her risk. If she is deemed at high risk by the test, then she might need chemotherapy.

Agendia began communicating with physicians about the test errors on March 3, providing them with background information on the issue, as well as corrected results.

Agendia has not publicly identified the developer of the faulty reagent, noting that the provider is "a respected third-party vendor" whose reagents are "widely used in both commercial and academic laboratories."

Agilent manufactures the microarrays that underlie the MammaPrint test and Agendia also has a supply agreement with Asuragen for RNARetain, a molecular fixative that preserves fresh tissue samples ahead of analysis. Both Agilent and Asuragen have said their reagents did not cause MammaPrint tests to over-report patients' recurrence risk.

TR

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