Failure of individual assays may occur due to problems with specimen quality or technical issues. Negative findings do not rule out the presence of an abnormality, and not all positive findings are indicative of an abnormality. All findings should be correlated with patients’ clinical history and imaging.
This test has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is for diagnostic purposes. It should not be regarded as investigational or for research.
Precision Pathology Services Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity clinical laboratory testing.
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