TriNetra™ – Triumph is an advanced non-invasive blood test which provides evidence of an underlying malignancy via a safe, simple and quick blood draw. TriNetra™ – Triumph evaluates blood sample to detect ‘Circulating Tumor Cells’ (CTCs), which are cancer cells that escape from the tumor and enter the blood stream. TriNetra™ – Triumph enriches these CTCs from the blood sample and confirms their identity via a process called ‘Immunocytochemistry’ (ICC). A positive CTC finding is indicative of the presence of an underlying cancer whereas when CTCs are undetectable, the patient may not have a cancer.
TriNetra™ – Triumph detects CTCs, which are known to be present (and detected ubiquitously) in most types of cancers called solid tumors. Several prior clinical studies, including DCG’s own acclaimed studies have shown that CTCs are detectable even in very early Stage 0 (in situ cancer) as well as Stage I and Stage II malignancies. CTCs are detected across all solid organ tumor types and subtypes, in men and women. CTCs do not exist in individuals without cancer. CTCs are undetectable in blood of patients with noncancerous (benign) tumors. Owing to these properties, CTCs have high accuracy for cancer detection2,3,4,5,6,7.
TriNetra™-Triumph has been clinically validated by one of the world’s largest clinical trials. The validation in a large cohort clinical study is based on samples from more than 34,000 known cancer patients and more than 23,000 healthy individuals2,3,4,5.
TriNetra™-Triumph test detects following 50 types of cancers8:
Essential Safety Information
The TriNetra™-Triumph test is advised for use in adults 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 should be used in addition to other cancer screening procedures advised by a healthcare professional. The objective of using TriNetra™-Triumph is to identify cancer footprints i.e. CTCs and identify the probable organ / location that may be affected. TriNetra™-Triumph should not be used by pregnant women. TriNetra™-Triumph should never be used as the sole means of diagnosis and the results must always be corroborated by Standard of Care methodologies undertaken through a duly qualified and authorized medical professional.
A healthcare professional should interpret the results in light of the patient’s medical history, physical symptoms, and clinical indicators. A “No Circulating Tumor Cells Detected” test result merely signifies a reduced risk of presence of cancer but it however does not definitively exclude the possibility of cancer. A “Circulating Tumor Cells Detected” test result must necessarily be confirmed by independent diagnostic evaluation using medically accepted Standard of Care techniques (like imaging, for example) and a positive result does not confirm the existence of cancer.
If additional testing does not confirm the presence of cancer, it may indicate that cancer is not currently present (the TriNetra™-Triumph test is ‘false-positive’), and ‘watchful waiting’ is advised subject to the opinion of the individual’s prescribing physician. It is clarified that owing to the diverse biological behavior of cancer and/or the technical limitations of the performance of the test, it is possible for the test findings to be both false-positive (a biological footprint suggestive of cancer is found when cancer is not present) and false-negative (a biological footprint suggestive of cancer is not identified when cancer is present). Prescription Required.
Information from the laboratory about the test
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) has certified Datar Cancer Genetics clinical laboratory in Guildford, UK, and the College of American Pathologists (CAP) has granted it accreditation. The TriNetra™-Triumph test was developed by Datar Cancer Genetics, and the laboratory has determined the performance parameters of the test. The Food and Drug Administration (US-FDA) has neither approved, endorsed, nor cleared the TriNetra™-Triumph test. High-complexity testing is regulated under the CLIA regime in the Company’s clinical laboratory. The TriNetra™-Triumph test is designed to be used in a clinical setting only.
1. US Preventive Services Task Force. Recommendations Cancer. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.
2. Akolkar et al, Circulating ensembles of tumor-associated cells: A redoubtable new systemic hallmark of cancer, Int J Oncol 2019, https://doi.org/10.1002/ijc.32815.
3. Ranade et al, Hallmark Circulating Tumor-Associated Cell Clusters Signify 230 Times Higher One-Year Cancer Risk, Cancer Prev Res (Phila) (2021) 14 (1): 11–16, https://doi.org/10.1158/1940-6207.CAPR-20-0322
4. Gaya et al., Evaluation of circulating tumor cell clusters for pan-cancer noninvasive diagnostic triaging. Cancer Cytopathol 2021. https://doi.org/10.1002/cncy.22366
5. Limaye et al. Accurate prostate cancer detection based on enrichment and characterization of prostate cancer specific circulating tumor cells. Cancer Med. 2023; 12: 9116- 9127. doi:10.1002/cam4.5649
6. Crook et al. Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells. Cancers 2022, 14, 3341. https://doi.org/10.3390/cancers14143341.
7. Lawrence, R., et al. Circulating tumour cells for early detection of clinically relevant cancer. Nat Rev Clin Oncol 20, 487–500 (2023). https://doi.org/10.1038/s41571-023-00781-y.
8. TriNetra™-Triumph test is capable of indicating the likely presence of solid organ cancers (epithelial cancer subtypes).
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