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FDA Provides Notice on Agendia's Ongoing MammaPrint Recall

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Originally published May 14.

By Turna Ray

An April 21 enforcement report from the US Food and Drug Administration informed consumers and medical device manufacturers that Agendia's recall of a batch of its MammaPrint tests was still ongoing as of that date.

Agendia initiated a recall of its multi-gene breast cancer recurrence test on March 3 following an FDA inspection of its facilities in Huntington Beach, Calif. That inspection revealed that a batch of reagents "caused a marginal shift in MammaPrint reporting" (PGx Reporter 04/14/10).

Although FDA's notice suggests that the company-initiated recall was still ongoing in late April, in mid-April Agendia told PGx Reporter that it had notified all of the physicians who received these results "and provided new, corrected MammaPrint reports."

While at the time, Agendia would not say how many patient's test results were affected, the FDA notice said that over a period of about six months approximately 15 percent of MammaPrint results over-reported the chance of metastasis risk as 29 percent risk of recurrence instead of 10 percent.

"This over-reporting of risk did not cause direct injury to patients," the FDA notes. "However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy."

MammaPrint is a microarray-based diagnostics 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.

According to FDA's notice, Agendia began communicating with physicians about the test errors on March 3. "The firm's representatives will meet with treating physicians in person while having the corrected results in hand to inform each in person of the action, to allow a decision of the best course of action," the FDA notice informs.

Agendia will provide doctors with background information on the issue, as well as corrected results. Physicians would also receive a corrected report per patient by FedEx in order to ensure that each patient had received the corrected information.

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.

Asuragen President Rollie Carlson told PGx Reporter last month that Agendia had confirmed that the recent issues regarding MammaPrint "were not associated with RNARetain RNA stabilization reagent." RNARetain is the diagnostic version of the Ambion RNAlater research reagent.

Likewise, Agilent told PGx Reporter this week that its reagents were not involved in the faulty results.

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