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The Precision Epigenomics liquid biopsy test, EPISEEK, is a blood-based multi-cancer 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 60 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, brain glioma, 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 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 in general outperform all available 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 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.

The test is currently available to most patients in the United States, Canada, and Central America. Currently we cannot accept samples that were collected in New York State.

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.

Currently, EPISEEK is not covered by major insurance carriers, including Medicare.

Because policies vary among HSA and FSA administrators, patients should contact their insurance companies or plan administrators for details on using their accounts for Precision Epigenomics’ liquid biopsy test. In general, patients have been able to use their HSA/FSA for EPISEEK.

Our clinician portal allows you to order kits to keep on hand, kits to be shipped to patients directly, the ability to register a kit to a patient to be tested, and to get results delivered to your practice in a number of ways. Please contact us through support@precision-epigenomics.com for onboarding information.

A peripheral whole-blood specimen, submitted in the two Streck Cell-Free DNA tubes (10 mL each) that are provided in the collection kit, is needed for analysis. The patient need not fast or skip medications. Because the laboratory intends to process the specimen the day after collection, specimens should be collected and submitted only on days that precede workdays (typically Monday through Thursday morning, excluding holiday weekends). Specimens must not freeze, and they should be stored and transported at 37–87°F. A specimen will be rejected if it is submitted in blood collection tubes other than the provided Streck Cell-Free DNA tubes, submitted in expired collection tubes, less than 10 mL total, illegible or not properly labeled with two unique identifiers, hemolyzed or clotted, not received within 48 hours of collection, or not accompanied by a complete order.

No special preparation, pausing of medication, or fasting is required. Other blood collection tubes for other tests collected at the same time will not interfere with EPISEEK. High-intensity exercise within six hours prior to specimen collection may impact test results, so this should be avoided.

In most cases, the test results are available in about one week from arrival in our laboratory.

Precision Epigenomics issues reports electronically through its portal or by fax. Patients should be in touch with the ordering clinician if they have not received results within two weeks from their blood collection date.

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.

Screening tests usually do not diagnose cancer. They are designed to detect possible cancer in an otherwise healthy population. For example, a screening mammogram may find a density in the breast. That lesion may be cancer or benign calcification. An elevated prostate-specific antigen (PSA) level might be found as part of a man’s wellness check. It might be due to cancer or inflammation. Similarly, if a screening test such as Precision Epigenomics’ liquid biopsy test is abnormal, more tests are required to determine if cancer is present. We designed EPISEEK to be a screening test, not a diagnostic test.

The evaluation of a patient with an abnormal screening test result, such as “Abnormal Methylation Signal Detected” by EPISEEK, must be managed by the patient’s qualified healthcare provider. This may include detailed history and physical examination with special attention to known risk factors, additional laboratory studies, radiology studies such as PET/CT imaging, and even tissue biopsy, among other diagnostic maneuvers. “Abnormal Methylation Signal Detected” by EPISEEK does not equate to a diagnosis of cancer. Our Provider Interpretation Guide can be viewed and downloaded here.

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 a variety of reasons—such as a hemolyzed specimen, unlabeled specimen, insufficient specimen quantity, delayed transportation, or technical difficulties in the laboratory—the specimen may be reported as canceled. Please contact our laboratory at (520) 372-7522 or support@precision-epigenomics.com to coordinate the submission of an additional specimen to be tested.

We understand the importance of providing comprehensive information to patients regarding the testing procedures and results.

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