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This test was developed, and its performance characteristics determined by Genomic Health, Inc. The Oncodetect test was clinically validated in colorectal cancer patients with stage II-IV disease. Performance characteristics may not apply in tumor types not included in this test’s clinical validation. The test has not been cleared or approved by the US Food and Drug Administration. The test has been validated as a Laboratory Developed Test per institutional and applicable CLIA regulation (CLIA# 03D2048606) and College of American Pathology (CAP# 8869063) as qualified to perform high complexity clinical laboratory testing.