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The Avantect Pancreatic Cancer Test is an early detection test. The test does not establish a diagnosis of pancreatic cancer, and results should be considered in the context of other clinical criteria. Definitive diagnosis of pancreatic cancer usually requires a series of imaging scans, blood tests, and a biopsy. Not all pancreatic cancers will be detected. Some patients with pancreatic cancer may have a “Signal not detected” result. Some patients without pancreatic cancer may have a “Signal detected” result. False-negative and false-positive results are possible. A “Signal not detected” result does not guarantee that no pancreatic cancer is present. In some cases, no result is obtained. While this is very uncommon, it may be caused by shipping delays or when there is not enough cell-free DNA for the test in the patient’s blood. If this happens, we generally ask for a repeat blood sample for testing at no extra cost.
The test was developed in the ClearNote Health CLIA-certified (CLIA# 05D2249973) and CAP-accredited (CAP# 9219174) laboratory and has not been cleared or approved by the US Food and Drug Administration (FDA).