EPISEEK: Early Cancer Detection Tool
Unlock the life-saving power of Precision Epigemonics early cancer detection tool. EPISEEK identifies over 20 prevalent cancer types, many of which have no other early detection test available.
Detecting the Undectable
When it comes to cancer, early detection is key to saving lives! With 610,000+ cancer deaths in the U.S. each year, most of which stemming from cancer types with no FDA-approved screening options, EPISEEK is making revolutionary strides in detecting cancers that have been previously undetectable in early stages.
The EPISEEK liquid biopsy blood test is intended to be used as a complementary tool to established cancer screening assessments. However in some cases, especially for cancer types that have no previously established screening test and are notoriously hard to detect, it may be the only warning sign currently available for providers.
Recent research from the University of Chicago shows that only 14% of cancers in the U.S. are diagnosed after the patient had a recommended screening test.
of diagnosed cancers do not have screening tests and account for 70% of all cancer-related deaths
of cancer cases still go undiagnosed after recommended screenings
life years saved in the U.S. from early-detection screenings.
Advancing Cancer Screening Accuracy
(sensitivity / specificity)
(sensitivity / specificity)
(sensitivity / specificity)
Technology
CpG cfDNA qPCR
Turn Around Time (TAT)*
5 Days
Lung (sensitivity / specificity)
80% / >98%
Breast (sensitivity / specificity)
54% / >98%
Pancreatic(sensitivity / specificity)
93% / >98%
Technology
CpG cfDNA NGS
Turn Around Time (TAT)*
10 Days
Lung (sensitivity / specificity)
75% / >99%
Breast (sensitivity / specificity)
31% / >99%
Pancreatic(sensitivity / specificity)
84% / >99%
Technology
Cancer Ag’s, AI
Turn Around Time (TAT)*
10 Days
Lung (sensitivity / specificity)
75% / >80%
Breast (sensitivity / specificity)
81% / >80%
Pancreatic(sensitivity / specificity)
89% / >80%
How It Works
To get started with EPISEEK, first connect with TruDiagnostic’s customer referral team here to find a partnered healthcare provider offering EPISEEK testing services. Your provider will place the order for your test and guide you through the entire process, from sample collection to results interpretation.
After a provider receives their EPISEEK order, they must assign and register individual tests to individual patients before our laboratory can complete sample analysis. Immediately before a provider collects a patient sample, the provider should register the kit’s unique barcode and patient information through their provider portal.
A peripheral whole blood specimen, submitted in the two Streck Cell-Free DNA tubes (10 ml each) which are provided in the collection kit, is needed for analysis. The patient does not need to be fasting. Because the laboratory intends to process the specimen the day after collection, specimens should be collected and submitted only on days which precede workdays (typically Monday through Thursday, 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, not properly labeled with two unique identifiers or is illegible, hemolyzed or clotted, not received within 48 hours of collection, or not accompanied by a registered kit with complete order.
The supplied kits, along with their contents, can be stored at room temperature. The Streck tube lot and expiration date are printed on the box exterior for easy kit management.
In most cases, test results are available within one week from arrival at our laboratory. Once ready, results can be accessed and viewed on TruDiagnostic’s provider portal.
FAQs
Most appropriately licensed medical providers who care for patients and are located in the United States may order EPISEEK through TruDiagnostic's Healthcare Provider portal (free account sign up here).
Accepted licenses includes: MD, DO, DDS, DPM, OD, NP, DC, and PA.
Due to regulatory restrictions at this time, we are unable to offer EPISEEK testing to providers and their patients who are located in New York, or outside of the United States.
The Precision Epigenomics Liquid Biopsy Test, EPISEEK, is a blood-based test designed to accurately assess DNA shed by tumors called circulating tumor DNA(ctDNA) to detect cancer from a simple blood draw. We analyze epigenomic modifications present on the ctDNA. Special software is used to analyze the results and aids the pathologist to issue a report that specifies if an abnormal signal is detected or if no cancer signal is detected.
We designed the Precision Epigenomics Liquid Biopsy Test to detect the presence of the most prevalent lethal solid tumors including lung cancer, breast cancer, prostate cancer, colorectal cancer, pancreatic cancer, head and neck cancer, urinary bladder cancer, and esophageal cancer. Further bioinformatic analysis showed the loci have high sensitivity and specificity for cervical squamous cell carcinoma, endo cervical adenocarcinoma, bile duct carcinoma (cholangiocarcinoma), DLBC lymphoma, glioma, liver hepatocellular carcinoma, mesothelioma, gastric adenocarcinoma, uterine endometrial carcinoma, and uterine carcinosarcoma. It’s important to note that the test may have limited sensitivity in early-stage cancers and should not be considered are placement for routine cancer screening such as colonoscopy, mammogram, and cervical cancer screening.
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. EPISEEK testing is not recommended for patients younger than twenty-one, those who are pregnant, or those who have an active known malignancy, or are currently being treated for cancer.
In most cases, the test results are available in about 1 week from arrival in our laboratory. As with other test offerings through TruDiagnostic, the result will be available through the provider portal.
A peripheral whole blood specimen, submitted in the two Streck Cell-Free DNA tubes(10 ml each) which are provided in the collection kit, is needed for analysis. The patient need not be fasting. Because the laboratory intends to process the specimen the day after collection, specimens should be collected and submitted only on days which precede workdays (typically Monday through Thursday, excluding holiday weekends). Specimens must not freeze, and they should be stored and transported at 37-87°F.3/6
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 than10 ml total, not properly labeled with two unique identifiers or is illegible, hemolyzed or clotted, not received within 48 hours of collection, or not accompanied by a complete order.
The supplied kits with its contents may be stored at room temperature. The Streck tube lot and expiration date are printed on the box exterior for easy kit management.
No special preparation, pausing 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 6 hours prior to specimen collection may impact test results so this should be avoided.
Pricing is determined by your healthcare provider.
Because policies vary among HSA and FSA administrators, patients should contact their insurance companies or plan administrators for details on using their accounts for EPISEEK testing.
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 presence of cancer. Patients who receive a 'Cancer Signal Not Detected' result should continue with all standard of care screening options at intervals appropriate for that individual.
We have designed EPISEEK to be sensitive to detecting a wide variety of cancers and created its algorithm to minimize False Positives. For a small number of patients, the signal may be more abnormal than in most healthy patients, but not as high as inpatients with clear cases of cancer. In this setting, we may issue an interpretation of an “Indeterminate Signal Detected.” For these patients, additional diagnostic follow-up is recommended, but this group will likely have more False Positives than the “Abnormal Signal Detected” category.
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 lump may be cancer or something else. 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 EPISEEK is abnormal, more tests may be done 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 Signal Detected” by EPISEEK must be managed by the patient’s qualified healthcare provider. This may include a detailed history and physical examination with special attention to known risk factors, additional laboratory studies, and studies such as PET/CT imaging, among other diagnostic maneuvers.