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Trucheck™

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

The following options are available:

  • Trucheck™ Breast

  • Trucheck™ Prostate

  • Trucheck™ Colorectal / Stomach

  • Trucheck™ Diabetes (Bladder, Colorectum, Gallbladder, Kidney, Liver, Pancreas)

  • Trucheck™ intelli (up to 70 solid tumours)

About Trucheck™

About 4.4 million new cancers are detected every year in Europe as well as about 2 million cancer related deaths. Unfortunately, some cancers are detected at advanced stages which necessitate more intensive and expensive treatments which have greater risk of side effects. Detection of cancers at early / local stages is vital for successful treatments, lower treatment costs, lower toxicities and improved survival. Trucheck™ is the culmination of years of collaborative international research and innovation and has been developed, tested and validated on > 40.000 individuals.

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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™ intelli can distinguish ~70 types of solid tumours which account for ~81% of all cancer cases and ~84% of all cancer related deaths in Europe.

  • Trucheck™ has a 92.1% sensitivity in detection of cancers across all stages and types. Further Trucheck™ intelli 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.

Who is Trucheck™ 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.

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Life en (200 × 100 px) (400 × 400 px).png
Life en (200 × 100 px) (400 × 400 px).png
Image by Braňo

About

Image by National Cancer Institute

Advantages

Image by Markus Krisetya

Sensitivity

&

Specificity

Image by National Cancer Institute

Method

Image by Sigmund

Publications

Image by Prasesh Shiwakoti (Lomash)

Sample Collection

 

Advantages

In contrast to screening for a single cancer at a time, TrucheckTM 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.

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TrucheckTM is an advanced comprehensive cancer detection that offers an unparalleled combination of sensitivity and specificity for early detection of cancers in asymptomatic individuals.

Image by National Cancer Institute

TrucheckTM intelli interrogates CTCs for the molecular imprint of the tumour mass from where the CTCs originated, i.e., TrucheckTM 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.

Image by National Cancer Institute
 

​Sensitivity and Specificity

Clinical Validation
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Preliminary clinical validation of TrucheckTM 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 TrucheckTM is not intended as a replacement for standard of care cancer screening, we benchmarked the clinical performance of TrucheckTM 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
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Trucheck™ in breast cancer detection
Breast
Trucheck™ in prostate cancer detection
Prostate

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.

 

Method

CTC 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, TrucheckTM 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.

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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, TrucheckTM 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. TrucheckTM includes markers that cover various subtypes of carcinomas as well as markers specific for other cancer types such as gliomas, sarcomas and neuroendocrine tumours.

TrucheckTM uses multiplexed fluorescence immunocytochemistry (ICC) to evaluated multiple markers in a single run with unique fluorophore conjugated antibodies.

 

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)

Gaya A. et al.

Evaluation of circulating tumor cell clusters for pan-cancer non-invasive diagnostic triaging. (ACS Journal, 2021)
Population - Cancers: 9.416 (Retrospective) & 6.025 (Prospective) • Benign: 700 • Asymptomatic: 13.919 (Prospective)
Parameters - Analyte: C-ETACs, CTCs • Assessment: Colony Detection Assay • Clinical Validation Study
Performance Characteristics - Specificity: 99.3% (Benign) & 85.2% (Retrospective) • Sensitivity: 100.0% (Asymptomatic) & 86.7% (Prospective)

 

Sample Collection

Requirements:

 

Total 3 tubes containing 17 ml whole blood

  • First draw: 2 ml SST tube (yellow colour cap)

  • Second draw: 2 x EDTA tubes (purple colour cap) of 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 4 °C in the container provided by DCG.

 

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

  • 10 days from receipt of sample

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