Artemis DNA™
Trucheck Pragma Cancer Early Detection
Recommended for asymptomatic individuals with a high risk of cancer in order to detect cancers early. Test is repeated every year as part of yearly check-up.
*Artemis DNA has exclusive commercial rights with Datar Cancer Genetics for Trucheck Pragma laboratory develop tests (“LDTs”) in Vietnam.
Why should I consider Cancer Early Detection?
WORLD: Estimated number of new cancer cases from 2020-2040, both sexes, all ages (0-85+)
ASIA: Estimated number of new cancer cases from 2020-2040, both sexes, all ages (0-85+)
WORLD: Estimated number of cancer deaths from 2020-2040, both sexes, all ages (0-85+)
ASIA: Estimated number of cancer deaths from 2020-2040, both sexes, all ages (0-85+)
Late-Stage Survival Rate compared to Early-Stage Survival Rate
Prostate Cancer
Lung Cancer
Breast Cancer
Stomach Cancer
Ovarian Cancer
Colorectal Cancer
Trucheck™ Pragma is a blood test that can enable early detection of multiple cancers in asymptomatic individuals.
Why should I consider Trucheck™ Pragma Cancer Early Detection?
- Circulating Tumor Cells (CTCs) and their clusters are present in the blood of almost all cancer patients and are undetectable even in seemingly healthy individuals.
- Trucheck™ Technology to detect and characterize CTCs has been proven through extensive clinical validations involving more than 40,000 participants.
- The test is a paradigm shift in cancer screening, as it does not involve radiation or invasive procedures.
- The test is performed at our world-class laboratory, which meets and exceeds all national and international standards.
Trucheck™ Pragma Technology
Trucheck™ Pragma Technology
- Trucheck™ Pragma detects circulating tumour cells (CTCs) and clusters of these CTCs which are released by malignant tumours, but not from non-cancerous (normal / benign tumour / inflammatory) tissue. Hence CTCs are ubiquitously seen in blood of cancer patients but absent in blood of healthy individuals.
- Trucheck™ Pragma has a 92.1% sensitivity in detection of cancers across all stages and types.
- Trucheck™ Pragma has a 93.1% accuracy in determining the tissue or organ of origin in positive cases.
- Trucheck™ Pragma displays a specificity of 99.9% (versus healthy individuals).
- Trucheck™ Pragma detects cancers irrespective of the extent of the disease, thus even early-stage cancers are reliably observed.
Trucheck™ Pragma is Recommended For
- Asymptomatic individuals who have a family history of cancer.
- Individuals who want to include this test in their yearly check-up.
- Asymptomatic individuals who have a high risk in cancer.
Trucheck™ Pragma Cancer Early Detection
Trucheck™ Pragma
Trucheck™ Pragma test is intended for early detection of Prostate (males), Breast (females), Ovary (females) along with Lung, Stomach and Colon, Pancreas cancers.
Illustrative Images Of Circulating Tumor Cells
BREAST
GCDFP-15
LUNG
NAPSIN-A
Trucheck™ Pragma Advantages
In contrast to screening for a single cancer at a time, Trucheck™ Pragma can identify multiple cancer types via a simple blood draw that may be undetectable by present technologies. Detection at earlier stages is associated with greater rates of successful treatment and improved survival.
Trucheck™ intelli interrogates CTCs for the molecular imprint of the tumour mass from where the CTCs originated, i.e., Trucheck™ intelli reveals diagnostically relevant information about the tissue / organ of origin of the tumor with high accuracy. This guides further investigations and reduces diagnostic trial and error.
Trucheck™ Pragma is an advanced comprehensive cancer detection that offers an unparalleled combination of sensitivity and specificity for early detection of cancers in asymptomatic individuals.
Trucheck™ Pragma Sensitivity and Specificity (Data by Datar Cancer Genetics)
| Cancer vs Asymptomatic | Cancer vs Benign | |
|---|---|---|
| Analytic Sensitivity | 85.74% (85.18% – 86.29%) | 85.74% (85.18% – 86.29%) |
| Analytic Specificity | 99,90% (99.97% – 100%) | 99.29% (98.34% – 99.77%) |
| Accuracy | 99.97% (99.94% – 99.99%) | 94.82% (94.46% – 95.15%) |
| Positive Predictive Value (PPV) | 99,90% | 98.34% (96.11% – 99.30%) |
| Negative Predictive Value (NPV) | 99.97% (99.97% – 99.97%) | 93.39% (93.15% – 93.63%) |
Preliminary clinical validation of Trucheck™ has been performed in a blinded prospective study involving 15,441 cancers, 700 benign cases and 13,919 asymptomatic individuals to establish the clinical performance characteristics (table above).
Though Trucheck™ is not intended as a replacement for standard of care cancer screening, we benchmarked the clinical performance of Trucheck™ against standard methods to demonstrate its viability and suitability as a primary test which can aid prioritisation of individuals into standard of care screening or detection pathways.
| Trucheck™ Pragma | Colonoscopy / CT Colongraphy | |
|---|---|---|
| Analytic Sensitivity | 82.6% | 73-98%3 |
| Analytic Specificity | 99,9% | 89% 3,4 |
| Positive Predictive Value (PPV) | 99,9% | – |
| Negative Predictive Value (NPV) | 99.9% | – |
| Trucheck™ Pragma | Colonoscopy / CT Colongraphy | |
|---|---|---|
| Analytic Sensitivity | 82.2% | 86.9% |
| Analytic Specificity | 99,9% | 88.9% |
| Positive Predictive Value (PPV) | 99,9% | 69.6%² |
| Negative Predictive Value (NPV) | 99.9% | 95.9%1,3 |
| Trucheck™ Pragma | PSA⁴ | |
|---|---|---|
| Analytic Sensitivity | 85.6% | 90.0% |
| Analytic Specificity | 99.9% | 19.7% |
| Positive Predictive Value (PPV) | 99,9% | 33.9% |
| Negative Predictive Value (NPV) | 99.9% | 81.0% |
Trucheck™ Pragma Methodology
Circulating Tumor Cells (CTCs) Enrichment
Conventional means for CTC enrichment have relied upon either immuno-affinity capture (magnetic) or size or charge-based separation (microfluidic devices). The former faces limitations with CTCs that express low amount of epitope or those which are sequestered in clusters with nonepitope expressing cells. In addition to low sensitivity, this also leads to low specificity by enriching incidental non-malignant cells that express the detection epitope. The latter has low capture rate of CTCs beyond the operational size / charge range of the device and can also enrich non-malignant cells with conform to detection parameters. In contrast, Trucheck™ employs an epigenetically activating medium (EAM) which negatively enriches CTCs via the cancer hallmark of evading apoptosis. When isolated PBMCs are treated with the EAM, all non-malignant cells are killed by their functional apoptosis machinery, whereas all cancer derived malignant cells (CTCs) survive.
Tissue and Organ of Origin Specific Markers
Conventional CTC based technologies infer the presence of CTC based on detection of EpCAM+, PanCK+ and CD45-cells. These technologies miss out on non-carcinoma cancers where these markers are known to be negative. In addition to overcoming the malignant v/s non-malignant conundrum by primary negative enrichment, Trucheck™ also incorporates evaluation of tissue organ of origin specific markers, which are known to be expressed in cancer cells and mostly absent in normal cells. Trucheck™ includes markers that cover various subtypes of carcinomas as well as markers specific for other cancer types such as gliomas, sarcomas and neuroendocrine tumours.
Trucheck™ uses multiplexed fluorescence immunocytochemistry (ICC) to evaluated multiple markers in a single run with unique fluorophore conjugated antibodies.
Trucheck™ Pragma Sample Collection
Requirements:
Total 3 tubes containing 17 ml whole blood.
1. First Draw: 1 of SST tube (yellow cap) – total 2 ml
2. Second Draw: 2 or 3 of EDTA tubes of 5 ml and 10 ml – total 15 ml
Note:
1. Sequence of draw should not be altered. Blood drawn should be performed only be qualified phlebotomist under medical supervision.
2. Do not centrifuge the blood specimen collected in the SST and EDTA tubes.
3. Store and Ship at 35.6°F to 46.4°F (2°C to 8°C).
4. Sample must arrive at laboratory within 48 hours of blood draw time.
5. All the tubes should be properly labelled with Patient Name, DOB, Gender, date and time of collection.
6. Do not use specimen collection tubes after the expiration date.
Precautions:
1. Patient has not received blood transfusion at least 10 days prior to collection of sample.
2. Patient is not positive for HIV / HBV / HCV.
Turnaround Time:
14-21 days from receipt of sample at our laboratory.
Trucheck™ Pragma CTC Publications
Circulating ensembles of tumor-associated cells: A redoubtable new systemic hallmark of cancer (International Journal of Cancer, 2020)
Population – Cancers: 5.509 (Retrospective) • Asymptomatic: 10.625 (Prospective)
Parameters – Analyte: C-ETACs, CTCs • Proof of Concept Study
Performance Characteristics – Specificity: 96.4% (Asymptomatic) • Sensitivity: 89.5% (Retrospective)
Hallmark Circulating Tumor-Associated Cell Clusters Signify 230 Times Higher One Year Cancer Risk. (AACR, 2021)
Population – Cancers: 5.509 (Retrospective) & 4.419 (P) • Benign: 324 (Prospective) • Asymptomatic: 10.625 (Prospective)
Parameters – Analyte: C-ETACs, CTCs • Assessment: Colony Detection Assay • Proof of Concept Follow-up Study
Performance Characteristics – Specificity: 97.5% (Benign) & 93.0% (Retrospective) • Sensitivity: 95.6% (Asymptomatic) & 93.0% (Prospective)
Circulating ensembles of tumor-associated cells: A redoubtable new systemic hallmark of cancer (International Journal of Cancer, 2020)
Population – Cancers: 5.509 (Retrospective) • Asymptomatic: 10.625 (Prospective)
Parameters – Analyte: C-ETACs, CTCs • Proof of Concept Study
Performance Characteristics – Specificity: 96.4% (Asymptomatic) • Sensitivity: 89.5% (Retrospective)
Trucheck™ Pragma Forms and Sample Report
Trucheck™ Pragma Frequently Asked Questions
Trucheck™ Pragma detects ‘existence of cancer’.
Trucheck™ Pragma is not intended to be and should not be considered as a replacement for any Standard of Care screening tests.
As Trucheck™ Pragma is a non-invasive blood test, there is no disadvantage in frequent testing. However, we advise that Trucheck™ Pragma should be performed every 12 months in case of Negative result.