Precision Epigenomics Inc. is a clinical reference laboratory registered under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. The EPISEEK test was developed, and its performance characteristics were determined by Precision Epigenomics Inc. The EPISEEK test has not been cleared or approved by the Food and Drug Administration. The EPISEEK laboratory-developed test is intended for clinical purposes. The EPISEEK test is recommended for use in adults with an elevated risk for cancer, such as those aged 45 or older. The EPISEEK test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The EPISEEK test is intended to detect abnormal cancer signals. The EPISEEK test is not recommended in people who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Please visit our website for additional important information. A healthcare provider should be able to interpret results in the context of medical history, clinical signs, and symptoms. A test result of “Cancer Signal Not Detected” does not rule out the possibility of cancer. A test result of “Abnormal Methylation Signal Detected” requires diagnostic evaluation by medically established procedures (e.g., imaging, additional laboratory testing, and possible invasive procedures) to evaluate the patient for malignancy.
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