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U.S. Department of Health and Human Services

Medical Devices

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Letter to Lumigenix Inc Concerning Direct to Consumer Advertising

May 11, 2011

Romain Bonjean
Chief Executive Officer
Lumigenix Inc
228 Hamilton Ave, Level 3
Palo Alto, CA 94301

Dear Mr. Bonjean:

It has come to our attention that you are currently marketing the Comprehensive Kit, a genetic testing service, intended to help individuals discover their genetic predisposition for 79 disease conditions such as breast cancer and take steps to maximize their health. The Comprehensive Kit appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.

We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Comprehensive Kit . We request that you provide us with the FDA clearance or approval number for the Comprehensive Kit . If you do not believe that you are required to obtain FDA clearance or approval for the Comprehensive Kit, please provide us with the basis for that determination.

We would like to meet with you to discuss whether the service you are promoting requires review by FDA and what information you would need to submit in order for your product to be legally marketed. Please let us know your availability and we will schedule a meeting with you. Please direct your questions and response to:

James L. Woods
Deputy Director, Patient Safety and Product Quality
Office of In Vitro Diagnostic Device Evaluation and Safety
10903 New Hampshire Avenue
White Oak 66
Silver Spring, MD 20993

We would appreciate a response within 15 days from the date of this letter. If you have any questions relating to this matter, please feel free to call Cecily Jones at 301-796-6172, or access our web site at http://www.fda.gov for general information relating to FDA's device requirements.

Sincerely yours,

James Woods
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health