Wednesday, June 11, 2008

US - California's "Cease & Desist" Letters

On June 9, 2008, the California Department of Public Health issued "cease & desist" letters to thirteen DTC companies.

The first three paragraphs:

"It has come to the attention of the California Department of Public Health (Department) Laboratory Field Services that _______ is in violation of California law. Business and Professions (B&P) Code Section1241 requires that all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performinag a clinical laboratory test or examination, possess a clinical laboratory license or registration.

_________ is also in violation of B&P Code Section 1288 which prohibits the offering of a clinical laboratory test directly to the consumer without a physician order, unless specifically exempt, Genetics tests are NOT exempt. As such, the test must be ordered by a physician or surgeon.

ln order to be granted a California clinical laboratory license, in addition to meeting all other
licensure requirements, __________ must provide satisfactory validation documentatio to verify the test performance specifications of all genetic tests."

(Read an actual copy of the letter here)

The California Department of Public Health (CDPH) cited "multiple anonymous complaints" as the reason for sending the letters. However, the CDPH will not release copies of the alleged complaints saying that they "do not disclose information pertaining to ongoing investigations".

Thirty-eight million people cannot buy DNA tests directly from thirteen companies and they are not able to know why.

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