FAQs
Most frequent questions and answers
TriNetra™-Triumph is an advanced blood test that provides evidence of an underlying cancer via a safe, simple and quick blood draw. TriNetra™-Triumph evaluates blood samples to detect ‘Circulating Tumor Cells (CTCs)’, which are cancer cells that escape from the tumor and enter the bloodstream.
If CTCs are present in any given sample, TriNetra™-Triumph enriches these CTCs and confirms their identity using the ‘Immunocytochemistry’ (ICC) technique. A positive CTCs finding is indicative of the likely presence of an underlying epithelial cancer, whereas when CTCs are undetectable, the patient may not have epithelial cancer.
The TriNetra™-Triumph test has been validated for the evaluation of the risk of the presence of various types of epithelial cancers like adenocarcinoma, squamous cell carcinoma, hepatocellular, renal cell, and transitional cell carcinoma. The CTC-based multi-organ screening tests performed using Datar Cancer Genetics’ technology have shown sensitivity of 88.24% for detection and localization of solid organ malignancies, while specificity of 96.3% was observed in asymptomatic individuals and specificity of 95% was observed in individuals with benign tumors.
The TriNetra™-Triumph is a prescription based test which is indicated for asymptomatic individuals with a higher risk of developing cancer, typically recommended for individuals above the age of 40 years and who do not have prior history of cancer. The TriNetra™-Triumph test is not intended to replace guideline-recommended cancer screening tests. TriNetra™-Triumph is designed to identify the risk of presence of multiple cancers like pancreatic, ovarian, liver, and esophageal cancers for which there are no existing recommended screening tests, and these cancers are not commonly screened. The United States Preventive Services Task Force (USPSTF) currently recommends screening programs only for lung (for high-risk smokers), breast, cervical, prostate, and colorectal cancers. TriNetra™-Triumph test should be used alongside existing cancer screening programs, such as mammograms and colonoscopies. In addition to screening for many cancers that lack structured screenings programs, the TriNetra™-Triumph test may also screen for cancers missed during routine screening, cancers in individuals who were non-adherent to current cancer screening tests, cancers that occurred during screening intervals, or cancers that occurred in individuals who lack access to existing screening tests.
The TriNetra™-Triumph test can only be ordered by a licensed healthcare provider which may include physicians, nurse practitioners, or physician’s assistants.
The TriNetra™-Triumph test is currently not included in any cancer screening guidelines.
Annual screening with TriNetra™-Triumph provides the opportunity for early cancer detection. It is up to the patient’s healthcare provider to determine the appropriate screening interval based on the individual’s underlying risk factors.
The TriNetra™-Triumph test is now available in the US. Datar Cancer Genetics’ CTC-based Multi-Cancer Early Detection test (MCED) has been available to eligible patients in the United Kingdom and Europe for the last couple of years.
The TriNetra™-Triumph test is currently not covered by insurance.
Specimen requirements include:
- Specimen Type: Human Whole Blood collected by a peripheral blood draw.
- Container: EDTA Collection Tubes.
- Volume: 20 mL.
- Sample Storage: Temperature 2 ‑8 ℃ range.
- Stability: 3 calendar days (72 hours).
Specimen rejection criteria include:
- Tubes other than the EDTA Blood Collection Tubes provided by Datar Cancer Genetics are received.
- Less than 7 mL of whole blood per collection tube.
- Unlabeled specimens.
- Severely damaged or dangerously packaged specimens.
- Specimens submitted or stored at a temperature outside of 2-8°C.
- Collection date greater than 3 calendar days prior to the start of processing.
- Specimens resulting in clotting or grossly hemolyzed plasma.
Collection kits should be stored at room temperature. Avoid storing the collection kits in places that experience high or low temperatures.
TriNetra™-Triumph test blood draw requires no preparation or fasting by the patient. Fasting for other blood draws will not affect the TriNetra™-Triumph test results.
Test results should be available within 12 business days from the date the sample arrives at Datar Cancer Genetics laboratory in the UK. Typically, a sample will arrive at the laboratory in 1-2 business days after the blood sample is shipped.
In rare scenarios where a sample is regretted, you will be notified about your sample’s status.
The TriNetra™-Triumph test results are shared with the ordering healthcare provider.
This means that the TriNetra™-Triumph test did not detect Circulating Tumor cells (CTCs) as evaluated by immunocytochemistry analysis by quantitative fluorescence microscopy. This is suggestive of a lower risk of the presence of cancer. Please be mindful that the TriNetra™-Triumph report does not completely rule out the presence of cancer, as some cancers may not shed detectable tumor cells in the blood. Individuals should be advised to continue participating in all recommended cancer screening options at appropriate intervals. If any signs and symptoms arise, timely clinical evaluation by qualified healthcare professionals is recommended.
This means that CTCs were detected in the given blood sample by the TriNetra™-Triumph test, which is suggestive of a higher risk of the presence of cancer. The reflex analysis of the test suggests likely organ of origin and cancer type. Individuals with such findings are advised consultation with their physician for appropriate guidance and additional standard of care workup as may be advised. A ‘Circulating Tumor Cells (CTCs) detected’ result is not a diagnosis of cancer.
The TriNetra™-Triumph test is a screening test, not a diagnostic test. It is important to follow up with diagnostic testing to confirm the presence of cancer.
The detection of CTCs in the given blood sample is suggestive of a higher risk of the presence of cancer, and the reflex analysis will indicate likely organ of origin and cancer type. In certain samples, CTCs may be detected, but the type of cancer or organ of origin may not be indicated if organ-specific immunocytochemistry markers are not adequately expressed. The reflex analysis is provided to help guide the diagnostic evaluation needed to confirm the presence of cancer.
When the TriNetra™-Triumph test indicates a higher risk of the presence of a particular cancer, the finding must be confirmed by diagnostic tests in accordance with standard medical practice. These results should be interpreted in the context of the individual’s clinical risk factors. Diagnostic decisions are the responsibility of the treating physician. When Circulating Tumor cells are detected, even after a negative diagnostic evaluation of a particular cancer, the likelihood that the individual has cancer remains elevated and may warrant further evaluation.
This could mean that the individual has cancer that is difficult to identify by the selected follow-up diagnostic procedures or that the result of the TriNetra™-Triumph test is false positive and that the individual does not have cancer. Testing may be insufficient to detect cancer due to the cancer being located in a different part of the body. Healthcare providers should use their independent clinical judgment for patient diagnosis, treatment, and care.
The TriNetra™-Triumph test results do not report incidental findings.