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"Cancer is a word, not a sentence."
- John Diamond

Pathway Genomics’ Response to FDA Letter on CancerIntercept™ Detect

Pathway Genomics greatly respects and shares the FDA’s concerns about patient safety. We have received a letter from FDA, dated September 21, 2015, requesting certain information regarding the Pathway Genomics CancerIntercept™ Detect testing service. We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter. We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept™ testing. We believe that CancerIntercept™ Detect is a laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering it as such. While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model. We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.