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Demand Emboldens Agendia to Add US Labs, Seek FDA OK for Post-Menopausal Women

Dutch diagnostics shop Agendia announced last week that it hopes to sell more of its MammaPrint breast cancer diagnostic test in the US by enlisting the help of two American reference centers and streamlining the procedure for shipping samples to its testing facility in Amsterdam.
Separately, this week the firm said it plans to ask the FDA to expand its clearance of MammaPrint for use in women older than 60 years.
The company said that it has completed a study that has shown the test to be useful in assessing the risk of the recurrence of breast cancer in post-menopausal patients.
“MammaPrint is now independently validated for both pre-menopausal and post-menopausal women, an important and necessary validation considering that breast cancer biology between the two groups is different,” Agendia CEO Bernhard Sixt said in a statement. “We are confident that we now have enough data to seek clearance from the FDA for use of this test in breast cancer patients of all ages.”
The FDA in February cleared the product for use in women younger than 61 who have Stage I or Stage II breast cancer and who are lymph node negative (see BAN 2/13/2007). Four months later, the FDA cleared Agendia’s RNARetain sample-storage solution for use in a clinical setting (see BAN 9/4/2007).
According to Sixt, Agendia is now working with the University of California, San Francisco’s Medical Center at Mount Zion and the Baylor College of Medicine’s Dan L. Duncan Cancer Center to reach more breast cancer patients that want to use the MammaPrint assay to assess their risk for recurrence.
Sixt told BioArray News in an e-mail last week that the deals with UCSF and Baylor represent Agendia’s strategy for reaching the US market, and that arrangements with other reference centers in the US are being discussed.
Additionally, Agendia will eventually seek to build its own testing facility in the US that will enable it to better serve the North American market.
“That our FDA-cleared production line is located in our CLIA-certified facilities in Amsterdam has no impact on the service level we provide to our customers,” Sixt wrote. “However, to meet demand we are planning to open a central service laboratory in the US in the near future.” The company has not yet determined a timeline for that to happen.

“To meet demand we are planning to open a central service laboratory in the US in the near future.”

According to Sixt, the company intends to raise its sales and marketing presence within the United States in the coming months.
As part of Agendia’s focus on the US market, the firm has also modified its RNARetain stabilizing solution to allow tumor biopsies to be shipped without the need for freezing or cooling. Doctors will receive their results within seven to 10 days after the biopsy is taken, Sixt said.
“All that a physician has to do is to submerge a punch biopsy of the tumor into the provided RNARetain vial and call FedEx,” Sixt said. Additionally, Agendia has upgraded its web-based customer ordering system to make it easier to order the test from the US, he said.
Sixt noted that one advantage of MammaPrint is the fact that it has “no non-informative intermediate group. This, coupled with the relatively quick turnaround time for the test, “allow [us to] very quickly [take] away the patient's anxiety and provide additional information for both physician and patient to come to a more qualified decision [about] what to do next.” 
Another FDA Clearance?
Agendia is also looking to expand the reach of the test by broadening its available market. This week, the company said that it will seek clearance from the FDA to market MammaPrint to women aged 60 years and older.
According to the FDA’s February decision to approve MammaPrint, the 70-marker gene-signature test is currently approved for women “who are less than 61 years old, with Stage I or Stage II disease, with tumor size [less than or equal to] 5.0 cm, and who are lymph node negative.”
Agendia received a second clearance from the FDA in June to offer the test with RNARetain. The company said it now has data that supports a third clearance and will expand its market to include post-menopausal women.
To that end, Agendia has been using the MammaPrint to evaluate breast cancer tumor samples in 100 patients with a median age of 62 years. In that study, which used samples collected by Massachusetts General Hospital, Agendia used the assay to classify patients as being at either low or high risk for distant metastasis, and compared the results to actual disease outcomes in patients with positive results. The company is now planning to submit the results of the study for publication.

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