Letter to Agendia B.V.

DEPARTMENT OF HEALTH & HUMAN SERVICES
	Food and Drug Administration 2098 Gaither Road Rockville MD 20850 April 6, 2005

Via Federal Express

Dr. Bernard Sixt
Chief Executive Officer
Agendia B.V.
Slotervaart Hospital
Floor 9D
Louwesweg 6
NL-1066 EC Amsterdam
The Netherlands

Dear Dr. Sixt:

We are writing you because The Food and Drug Administration (FDA) obtained information from your website, www.agendia.com, and your December 8, 2004 press release indicating that you intend to distribute the MammaPrint® diagnostic test in the U.S. Your internet site and press release state that MammaPrint® is a “diagnostic test” and can “assess the risk of breast cancer progression….” Additionally, your internet site and press release state that the MammaPrint®, “allows the identification of a group of high risk patients...” and is a “validated 70-gene signature... that predicts the development of distant metastases.” According to the press release, “MammaPrint® outperformed all currently-used standard diagnostic criteria in predicting future development of distant metastases….” This product appears to be manufactured and/or commercially distributed by your firm.

Under a United States federal law, known as the Federal Food, Drug and Cosmetic Act (Act), diagnostic tests may be devices if they are intended for use in the diagnosis of disease or other conditions (21U.S.C. 321(h)). In general, the Act requires that manufacturers of devices obtain FDA clearance or approval before marketing. This helps protect the public health by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country. The kind of information a manufacturer needs to submit in order to obtain clearance or approval is described in our web site at: http://www.fda.gov/cdrh/devadvice.

Based on information from your internet site and press release, FDA is concerned that the MammaPrint® may not be in conformance with the Act, including the requirements related to marketing clearance or approval. We invite you to meet with us at your earliest convenience to discuss the proper regulation of the MammaPrint®. We are committed to ensuring that any premarket requirements that may result from this would follow CDRH's approach of using the least burdensome regulatory tools needed to protect the public heath.

Please contact me, at (240) 276-0484, to set up a meeting. We look forward to working with you to help provide novel, safe and effective products to patients and health care providers.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health