Talk

It’s official: DNA Direct has received a formal letter from the California Department of Public Health (CDPH) stating that we are operating in compliance with state laboratory law. Specifically, the letter states that DNA Direct’s tests are performed only with a physician order and are conducted at licensed laboratories, and that DNA Direct gives validated interpretations of results directly to persons ordering the tests and provides publicly available education material to the person ordering the test to aid in his or her understanding.

“The CDPH has taken a proactive and decisive approach to the regulation of genetic testing with the public’s safety and concerns top of mind,” says Ryan Phelan, DNA Direct’s founder and CEO. “This communication from the CDPH enables us to reassure California residents that DNA Direct continues to operate within the appropriate regulatory framework and that consumers can depend upon us for convenient, secure and clinically-valid personal genetic information and testing services.”

(I might also add that DNA Direct was the first company to create transparent standards for web-enabled genetic services that follow medical guidelines from the National Society of Genetic Counselors and the American College of Medical Genetics for applicable tests.)

• See the letter confirming compliance from the CDPH
• See NSGC and ACMG Guidelines and Our Standards