Technology
- Currently standard screening is available only for cancers of the breasts, lungs, prostate, cervix and colon as individual procedures1.
- Having to undergo a separate screening test for each cancer type may be inconvenient as it may necessitate prior appointments and may involve wait times.
- There is an overall low compliance with screening procedures due to these and other factors.
- Further, there are several cancers, including aggressive types, for which screening is not currently offered.
- A simple non-invasive, non-radiological test which has the capability to detect single cancer or multiple types of cancers in asymptomatic individuals is an unmet clinical need.
- Such a test can effectively identify individuals who may benefit from screening procedures as well as additional follow-up.
- Such a test can also improve compliance with cancer screening and help improve early detection as well as early detection rates.
- Such a test can help expand the scope of early detection to include several aggressive cancers.
TriNetra™ cancer screening addresses these challenges.
About TriNetra™-Triumph
Reliable Technology
Our Novel Process Selectively Eliminates (Negative Enrichment) Normal Cells and
Permits Survival of Cancer Cells (CTCs)
(CEM = CTC Enrichment Medium, PBMCs = Peripheral Blood Mononuclear Cells)
Our novel functional CTC enrichment process is based on apoptosis reluctance, a hallmark of cancer cells. Non-malignant epithelial, endothelial and hematolymphoid cells have an intact apoptosis mechanism and are thus eliminated during the process, while malignant cells evade apoptosis and survive.
Clinically Proven
TriNetra™ - Triumph
TriNetra™-Triumph test detects following 50 types of cancers8:
- Adenocarcinoma (AD): Bile Duct, Breast, Colon, Duodenum, Esophagogastric Junction, Esophagus, Gall Bladder, Ileum, Jejunum, Liver, Lung, Ovary, Pancreas, Prostate, Rectum, Stomach, Thyroid, Uterus, Salivary Duct, Cervix, Kidney.
- Adenosquamous Carcinoma: Esophagus, Gall Bladder, Cervix, Lung.
- Mesothelioma: Pleural, Peritoneal.
- Squamous Cell Carcinoma (SCC): Anorectum, Buccal Mucosa, Cervix, Esophagus, Hard Palate, Larynx, Lip, Lung, Oral Cavity, Paranasal Sinuses, Penis, Pharynx, Pyriform Fossa, Retromolar Trigone, Skin, Soft palate, Tongue, Tonsil, Vulva, Vagina.
- Transitional Cell Carcinoma (TCC): Urinary Bladder, Renal Pelvis, Ureter.
Essential Safety Information
- TriNetraTM– Triumph is a ‘prescription only’ test.
- TriNetraTM-Triumph is recommended / suggested for use in asymptomatic adults with neither prior diagnosis of cancer, nor current suspicion of cancer, typically for individuals aged 40 years and above.
- TriNetraTM-Triumph is not meant to replace standard of care cancer screening and diagnosis procedures.
- The TriNetraTM-Triumph test should be used in addition to other cancer screening procedures advised by a healthcare professional.
- TriNetraTM-Triumph is not intended to be used by pregnant women.
- TriNetraTM-Triumph should never be used as the sole means of cancer detection / diagnosis.
- TriNetraTM-Triumph results must be (a) interpreted by a clinician in conjunction with the individual’s health / medical history as well as all other clinical evidence and diagnostic findings, and (b) corroborated by Standard of Care methodologies performed by qualified and authorized healthcare providers.
- Negative finding on TriNetraTM-Triumph (no CTCs detected) is not confirmatory for the absence of cancer. The mechanism of CTC shedding by tumors into blood is not completely understood and hence CTCs may not always be present in blood. CTCs are whole cells and their distribution in circulating blood is dissimilar to other (‘soluble’) tumor analytes such as proteins and nucleic acids. CTCs exhibit diverse morphological characteristics, not all of which may be amenable to detection.
- Positive finding on TriNetraTM-Triumph is not a confirmatory diagnosis of cancer. CTCs may be detected in individuals without cancer owing to the interplay of carcinogenesis and the anticancer immune mechanisms. CTC detection may also precede clinical or radiological manifestation by several months or years. Hence positive findings on TriNetra Triumph must necessarily be confirmed by appropriate standard of care investigations. If additional testing does not confirm the presence of cancer, the options of ‘watchful waiting’ or surveillance may be considered by the healthcare provider.
- TriNetraTM-Triumph test is not intended for detection of cancers in individuals who may be symptomatic or having suspicious clinical / radiological findings.
- The suitability of TriNetraTM-Triumph testing as well as its potential benefits and risk must be determined for an individual by the clinician.
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.
- The performance characteristics (Accuracy, Sensitivity, Specificity, NPV, PPV, etc.) of the Test are shown based on the case-control clinical studies performed by the Company under strict protocols.
- Performance of the Test in the real-world setting has not yet been established and the Company makes no claims/representation that the real-world performance of the Test will be similar to that of the case-control clinical studies.
- The nature of the Test, the disease, and the analyte are subject to biological dynamics which may not be freely understood and persons opting for the Test must obtain sufficient advice from a qualified physician regarding the suitability of the Test for a given individual.
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).