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Artemis DNA™ Trucheck™ Pragma
Early Cancer Screening

Trucheck™ is a new blood-based paradigm in multicancer detection.

Why should I consider Cancer Screening?

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
Breast Cancer
Ovarian Cancer
Lung Cancer
Stomach Cancer
Colorectal Cancer
Trucheck™ is a blood test that can enable early detection of multiple cancers in asymptomatic individuals.

Why should I consider Trucheck™?

  • 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 characterise 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.

About Trucheck™

Trucheck™ Technology
  • Trucheck™ 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™ has a 92.1% sensitivity in detection of cancers across all stages and types.
  • Trucheck™ has a 93.1% accuracy in determining the tissue or organ of origin in positive cases.
  • Trucheck™ displays a specificity of 99.9% (versus healthy individuals).
  • Trucheck™ detects cancers irrespective of the extent of the disease, thus even early-stage cancers are reliably observed.
Trucheck™ 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.

About Trucheck™ – Pragma

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™ – Advantages

In contrast to screening for a single cancer at a time, Trucheck™ 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™ is an advanced comprehensive cancer detection that offers an unparalleled combination of sensitivity and specificity for early detection of cancers in asymptomatic individuals.

Trucheck™ – Sensitivity and Specificity

Clinical Validation

  • Sensitivity

    85.74% (85.18% - 86.29%)

    85.74% (85.18% - 86.29%)

  • Specifictiy

    99,90% (99.97% - 100%)

    99.29% (98.34% - 99.77%)

  • Accuracy

    99.97% (99.94% - 99.99%)

    94.82% (94.46% - 95.15%)

  • PPV

    99,90%

    98.34% (96.11% - 99.30%)

  • 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™ in colon cancer detection

  • Sensitivity

    82.6%

    73-98%3

  • Specifictiy

    99,9%

    89%3,4

  • PPV

    99,9%

    –

  • NPV

    99.9%

    –

Trucheck™ in breast cancer detection

  • Sensitivity

    88.2%

    86.9%

  • Specifictiy

    99,9%

    88.9%

  • PPV

    99,9%

    69.6%²

  • NPV

    99.9%

    95.9%1,3

Trucheck™ in prostate cancer detection

  • Sensitivity

    85.6%

    90.0%

  • Specifictiy

    99.9%

    19.7%

  • PPV

    99.9%

    33.9%

  • NPV

    99.9%

    81.0%

1. Lehman CD et al. National Performance Benchmarks for Modern Screening Digital Mammography: Update from the Breast Cancer Surveillance Consortium. Radiology. 2017 Apr; 283(1): 49-58. doi: 10.1148/radiol.2016161174.

2. PPV and NPV Calculated from data reported by Lehman et al (above).

3. USPSTF reported data.

4. McKiernan J et al. A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict High grade Prostate Cancer in Patients with Prostate – specific Antigen 2-10 ng/ml at Initial Biopsy. Eur Urol. 2018 Dec; 74(6):731-738. doi: 10.1016/j. eururo.2018.08.019.

Trucheck™ – 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™ – Sample Collection

Requirements: Total 3 tubes containing 17 ml whole blood

  • First draw: 1 of SST tube (yellow cap) – total 2 ml
  • Second draw: 2 or 3 of EDTA tube sof 5 ml and 10 ml – total 15 ml

Note

Sequence of draw should not be altered. Blood drawn should be performed only be qualified
phlebotomist under medical supervision. Ship at 39oF (4oC ) in the provided container.

Precautions

  • Patient has not received blood transfusion at least 10 days prior to collection of sample.
  • Patient is not positive for HIV / HBV / HCV.

Turn Around Time

  • 14-21 days from receipt of sample

Trucheck™ – CTC Publications

Akolkar D. et al.
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)
Renade A. et al.
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)
Akolkar D. et al.
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™ – Frequently Asked Questions

1. Does Trucheck™ detect ‘existence of cancer’ or ‘possibility of cancer’?

Trucheck™ detects ‘existence of cancer’.

 

2. Does  Trucheck™ replace conventional cancer screening like mammography?

Trucheck™ is not intended to be and should not be considered as a replacement for any Standard of Care screening tests.

 

3. Does a ‘Negative’ Trucheck™ result mean that I am ‘totally’ cancer free?

Within the limits of error, a ‘Negative’ result is a reasonable indication of undetectable cancer of the type covered by the test. For other cancers not covered by the test, no inference should be drawn from a ‘Negative’ result..

 

4. Does a ‘Negative’ Trucheck™ result mean that I am free from cancer forever?

A ‘Negative’ result means that at the time of the test there were no detectable cancer cells circulating in the blood.

 

5. How frequently should Trucheck™ be repeated?

As Trucheck™ is a non-invasive blood test, there is no disadvantage in frequent testing. However, we advise that Trucheck™ should be performed every 12 months in case of negative result.

 

6. If my Trucheck™ result is ‘Positive’, how do I find the location of the cancer?

The test indicates the location for the select types of cancers with high accuracy,
and in others the Tissue of Origin can be identified with reasonable accuracy. In all
cases of ‘Positive’ results, the Report should be interpreted by your physician who can
guide you on further course of action.

 

7. Is Trucheck™ recommended for a person suspected to have / has symptoms of cancer?

No, such individuals should seek expert medical advice without delay.

 

8. Can Trucheck™ be used to monitor recurrence after cancer treatment?

No.

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