Frequently Asked Questions

The Precision Epigenomics liquid biopsy test, EPISEEK, is a blood-based multi-cancer early detection test designed to accurately detect DNA shed by tumors called circulating tumor DNA (ctDNA) to detect cancer from a simple draw. We analyze epigenomic modifications present in the ctDNA. Proprietary software is used to analyze the data to generate a report that specifies if an abnormal methylation signal is present or if no cancer signal is detected.

EPISEEK was designed to detect the presence of abnormal DNA changes shared by more than 80 cancer types, including some of the deadliest tumors—e.g., lung cancer, liver cancer, pancreatic cancer, uterus (endometrial) cancer, pancreatic cancer, oropharyngeal (head and neck squamous cell carcinoma), bladder cancer, and esophageal cancer—ALL of which have been detected by the assay. EPISEEK also has detected breast cancer, colorectal cancer, cervical squamous cell carcinoma, endocervical adenocarcinoma, ovarian carcinoma, bile duct carcinoma (cholangiocarcinoma), DLBC lymphoma, myeloid and lymphoid leukemia, thyroid cancer, gastric adenocarcinoma, low- and high-grade brain cancer, cutaneous melanoma, cutaneous squamous cell carcinoma, testicular germ cell tumor, and plasma cell myeloma, among others. It’s important to note that the test has lower sensitivity in early-stage cancers and should not be considered a replacement for recommended cancer screening such as colonoscopy, mammogram, cervical cancer, and lung CT screening. In some cases, conventional screening, such as breast cancer, has superior performance when compared to MCED tests.

EPISEEK is a screening test designed to identify asymptomatic patients earlier. Screening tests are designed to rule in a disease state, but also to minimize false positive results in healthy individuals without cancer. This test may not perform as well in patients with a personal history of cancer or with symptoms or clinical findings that make cancer more likely. False positive results, abnormal EPISEEK results when no cancer is detectable on follow-up, are an expected finding for any screening test.

No. The Precision Epigenomics liquid biopsy test does not screen for hereditary risk of developing malignancy. It is designed to detect the presence of malignancy.

As with many cancer screening guidelines, our liquid biopsy test is recommended for use in adults aged 45 or older. Patients younger than 45 but with elevated risk factors might also benefit from testing, but the chances of a false positive (abnormal EPISEEK result, but no cancer is found) increases. EPISEEK testing is not recommended for patients younger than 21, those who are pregnant or are planning to become pregnant in the next three months, those who have an active known malignancy, or those who are currently being treated for cancer.

Single cancer conventional screening tests tend to outperform MCED tests for a single cancer. EPISEEK provides additional coverage for lung cancer, pancreatic cancer, brain cancer, liver cancer and more where conventional screening is otherwise unavailable. The test should not be considered a replacement for routine cancer screenings, such as colonoscopy, mammogram, and cervical cancer screening. Healthcare providers should continue to follow guideline recommendations for cancer screening in their patients.

An appropriately licensed medical provider who cares for the patient and is permitted to order laboratory testing in their jurisdiction, including MD, DO, ND, DDS, DPM, OD, NP, DC, and PA. If you prefer to use an independent healthcare provider to order the test, one can be provided as part of the online ordering process.

Liquid biopsy for multicancer detection is not yet recommended by major cancer-screening guidelines or by the US Preventive Services Task Force (USPSTF).

Annual health exams may be an appropriate time for a multi-cancer early detection test such as our liquid biopsy test, but patients are encouraged to discuss screening with their healthcare provider to determine an appropriate interval given their unique healthcare considerations. There are no specific guidelines on liquid biopsy multi-cancer detection liquid biopsy tests.

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. 

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.

We believe that clinicians and their patients should read and understand the position of independent groups on what is known and not yet known about MCED testing, such as EPISEEK. This can help with supported (shared) decision-making on whether MCED testing is right for them.

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