FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit

The Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). "This product," says FDA, "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." Recall that Genentech teemed up with 23andMe -- a personal genetics firm -- to collect spit from volunteers to find out why people respond differently to Avastin -- Genentech's expensive (up to $100,000 per year per patient) drug for the treatment of metastatic colorectal cancer, among others (see "Spit for Research: Will Genentech's Online Promotion Succeed?").The author of the letter -- Alberto Gutierrez, Director of FDA's Office of In vitro Diagnostics and Radiological Health -- seems pretty miffed at 23andme. You might even say he's "spitting mad" as indicated by this section of the letter: Read more ยป
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: 23andMe Avastin Genentech warning letter Source Type: blogs