For domestic patients, the fee of $699 covers the test-collection kit, the transportation materials, the delivery of the kit, phlebotomy (blood collection), the return overnight shipping to our clinical laboratory, the analysis, and the interpretation with a final report. For international testing, please contact us for additional details.

We designed EPISEEK to detect abnormal methylation patterns that may be present as circulating tumor DNA in the blood of patients with cancer but not present in normal blood or other tissues. In this case, the test did not detect these characteristic DNA methylation abnormalities. EPISEEK was not designed to detect all malignancies.

Not all cancers have enough abnormal DNA circulating in the blood to be detected. While EPISEEK was designed to be sensitive, a “Cancer Signal Not Detected” result does not completely rule out the possibility of cancer, especially small and slowly growing ones. Patients who receive a “Cancer Signal Not Detected” result should continue with all standard-of-care screening options at intervals appropriate for that individual.

The evaluation of a patient with an abnormal screening test result, such as “Abnormal Signal Detected” by EPISEEK must be managed by the patient’s qualified healthcare provider.

False positive EPISEEK results are possible and, given the low incidence of cancer in an average-risk screening population, may occur at a meaningful rate. One potential source of false positive or false negative results is pre-analytical sample compromise. Extreme heat, freezing, or prolonged transit times may cause DNA degradation that alters assay performance. The laboratory employs sample-level quality control metrics and process controls to mitigate this risk; however, residual effects may remain. Another potential source of false positive results is true biologic hypermethylation of cancer-associated genomic regions in the absence of detectable malignancy on imaging. These patients may harbor neoplasia below the limit of detection of imaging studies, or they may exhibit persistent methylation patterns driven by biological processes that are not yet fully understood and may or may not become clinically relevant. Recognizing that insurance may not always cover advanced imaging procedures, Precision Epigenomics is committed to supporting patients and their healthcare providers in some cases may cover up to $2,000 of imaging cost if the patient’s insurance denies payment.

For individuals seeking comprehensive information about the test and the associated informed consent, both patients and clinicians can turn to our Terms of Service. There, you can access easy-to-understand resources explaining the nature of the test, its benefits, and any potential risks involved. Additionally, the Terms of Service and Precision Epigenomics’ website provide comprehensive details on the informed consent process and the EPISEEK test, empowering individuals to make well-informed decisions about their healthcare.

We encourage both patients and clinicians to review in depth our Terms of Service and informed consent available at precision-epigenomics.com.

https://prevention.cancer.gov/major-programs/cancer-screening-research-network-csrn/questions-and-answers-about-multi-cancer#undefined