Little did I know however, the controversy that was about to erupt between 23andMe and the U.S. Food and Drug Administration (FDA).
An FDA Warning
On November 22, 2013, the FDA issued a warning letter to Ann Wojcicki, CEO of 23andMe, Inc., stating that FDA regulators believed that the Personal Genome Service (PGS) kits issued by the company to its customers are medical devices and should be regulated as such.
The FDA states in the letter: “This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”
Further, the FDA demanded that 23andMe stop marketing the kits as personal genomic units until the company receives clearance from the FDA.
While Wojcicki fought the FDA initially, she relented in early December, and in a letter to me and her other customers, she said: “We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives. Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
My results came in under the wire
I was perhaps one of the “lucky” ones whose saliva was being processed prior to the FDA mandate, and as a result, my results arrived near the end of 2013.
A few items of interest from the report:
- I am 98.9 percent European (which is very interesting to my family, as we’ve always been told that we have significant American Indian heritage);
- I am 2.5 percent Neanderthal;
- My famous relatives include Marie Antionette, Napoelon, Prince Philip, and Susan Sarandon; and
- I do not have the genetic markers for the cancers for which they test.
You may remember that I ended Part 1 of my blog post with information about a program that one of my primary care doctors suggested that I participate in to assess my risk for hereditary cancer. The laboratory assessment checked for genetic mutations known to cause the following cancers: female and male breast, colorectal, endometrial, gastric, ovarian, pancreatic, prostate and melanoma.
Well, despite a pretty rich family history of cancer, I learned that of the 27 genes tested, my results were “NEGATIVE: NO CLINICALLY ACTIONABLE MUTATION IDENTIFIED.”
I will never forget the smile on my doctor’s face as she entered the consult room that morning. “Good news” were some of the sweetest words I’ve ever heard.