FDA Wary of Pathway Genomics Liquid Biopsy
As tumor cells grow, they shed DNA into the person's blood. Analyzing a blood sample for circulating tumor DNA is often referred to as a liquid biopsy.
Pathway Genomics markets its CancerIntercept Detect test as a liquid biopsy for early detection of ten different types of cancer in undiagnosed patients. It analyzes circulating DNA for 96 mutations that occur in 9 oncogenes. Pathway Genomics is marketing its liquid biopsy directly to consumers. Individuals can purchase a subscription for $299, which allows them to check for cancer four times per year. Subscribers have their blood drawn at home by a company sanctioned phlebotomist and can remotely consult with a Pathway physician by telemedicine.
The Food and Drug Administration recently sent a warning letter to Pathway Genetics expressing concern that the company has not sufficiently validated its test and appears to be offering a direct to consumer marketing model that has not been approved and cleared by the FDA.
Pathway Genomics has rebutted the FDA, claiming that CancerIntercept Detect is a laboratory-developed test that can be offered by a CLIA and CAP certified clinical laboratory. The company also disputes that they are conducting direct to consumer marketing.
This is not the first time that the FDA has expressed concerns about Pathway Genetics marketing tactics. In May 2010, Pathway received a letter from FDA after they announced a plan to sell their test kits in Walgreens drug stores without prior FDA clearance. Pathway had to abandon its direct to consumer marketing strategy.
The warning letter can be read by clicking on this link.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm211866.htm
Pathway Genomics gets FDA warning letter for its liquid biopsy test, Meghana Keshavan, MedCity News, September 25, 2015
FDA Sends Pathway Genomics Untitled Letter Over Liquid Biopsy Test, GenomeWeb, Sep 24, 2015.
Pathway Genomics responds to FDA’s concerns on liquid biopsy test, Meghana keshavan, MedCity News, Sep 25, 2015
