Early Cancer Screening

Trucheck™ is a blood-based screening test for solid tumours.

The following options are available:

  • Trucheck™ intelli (up to 70 solid tumours)
  • Trucheck™ FemmeSafe (Breast, Ovaries, Uterus, Cervix)

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 first diagnosed in advanced stages which entail more intensive and expensive treatments with a greater risk of side effects. Detecting cancers at an early / local stage is vital for successful treatments, fewer treatment costs and lower toxicities. Trucheck™ is the culmination of years of collaborative international research and innovation on circulating tumour cells and has been developed, tested and validated on > 57.000 individuals.

Trucheck™ technology

  • Trucheck™ detects circulating tumour cells (CTCs) which are released by malignant tumours, but not from non-cancerous (normal / benign tumour / inflammatory) tissue.
  • Trucheck™ intelli can distinguish up to 70 types of solid tumours which account for ~81% of all cancer cases and ~84% of all cancer related deaths in Europe.
  • In clinical studies, Trucheck™ has a sensitivity of 88% in the detection of cancer at all stages and types.
  • Real-world data has shown a sensitivity, depending on the tumor, of 65% - 89% and a specificity of 96% - 99%.

Trucheck™ is particulary recommended for ...

<p>... asymptomatic individuals who have a family history of cancer.</p>

... asymptomatic individuals who have a family history of cancer.

<p>... individuals who want to include this test in their yearly check-up.</p>

... individuals who want to include this test in their yearly check-up.

<p>... asymptomatic individuals who have a high risk in cancer.</p>

... asymptomatic individuals who have a high risk in cancer.

<p>... individuals between the ages of 40 and 70 who have never been diagnosed with any cancer.</p>

... individuals between the ages of 40 and 70 who have never been diagnosed with any cancer.

<p>... individuals with no current clinical or radiological suspicion of cancer.</p>

... individuals with no current clinical or radiological suspicion of cancer.

Important 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) & 95.6% (Asymptomatic) • Sensitivity: 93.0% (Retrospective) & 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) & 100.0% (Asymptomatic) • Sensitivity: 85.2% (Retrospective) & 86.7% (Prospective)

  • Crook T. et al.

    Accurate screening for early-stage breast cancer by detection and profiling of circulating tumor cells. (Cancers, 2022)
    Case-Control Study
    Population - Breast Cancer Cases: 548 • Asymptomatic: 9.632
    Parameter - Analyte: Breast-Adenocarcinoma-Associated CTCs
    Performance Characteristics - Specificity: 100.0% • Sensitivity: 92.07%
    Prospective clinical study
    Population - Breast Cancer Cases: 112 • Benign Breast Conditions: 29
    Parameter - Analyte: Breast-Adenocarcinoma-Associated CTCs
    Performance Characteristics - Specificity: 93.1% • Sensitivity: 94.64%

Advantages

In contrast to screening for a single cancer type at a time, TrucheckTM can identify multiple cancer types via a simple blood draw, which may be undetectable by standard of care.

TrucheckTM examines CTCs for the molecular imprint of the tumour mass from where the CTCs originated; e.g., TrucheckTM reveals diagnostically relevant information about the tissue / organ of origin of the tumour with high accuracy.

CTC-based tests can be used in conjunction with traditional imaging studies. Combining different screening modalities may enhance the overall sensitivity and specificity of cancer detection, providing a more comprehensive assessment.

Whats (not) to expect

It is crucial to set realistic expectations for a screening test. Therefore, it is important to clearly define the benefits and limitations of such a test, as shown in the table beside. A realistic assessment helps to make the best possible use of the test, for example as part of a complete check-up.

View comparison (PDF)

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 peripheral blood mononuclear cells (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 positive, PanCK positive and CD45 negative cells. These technologies overlook cancers in which the cells have been shown to have other characteristics. TrucheckTM includes markers that cover various subtypes of carcinomas as well as markers that are specific for other cancer types such as gliomas.

Mikroskopische Aufnahmen angefärbter Zellen eines Krebspatienten

Microscopic images of stained cells from a cancer patient

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

Sample collection

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Requirements:
Total 3 tubes containing 30 ml whole blood
Blood draw: 3 EDTA tubes (purple colour cap) each 10 ml

Note
Blood draw should be performed only by qualified phlebotomist under medical supervision. Ship at +2 °C to +6 °C in the container provided by DCG.

Precautions
Patient should be fasting for at least 6 hours before blood sample is taken (drinking is permitted) and should not have received a blood transfusion for at least 10 days prior to collection.


Turn Around Time
10 working days (Monday - Friday) from receipt of sample

FAQ

Are there any age limits for the Trucheck™ analysis? If so, are exceptions possible?

Trucheck™ is advised for individuals between the ages of 40 and 70, as aging is an important risk factor for cancer. However, it can be offered to individuals aged 35-40 years if any of the following risk factors are applicable:
1. Family history of cancer and / or known carrier status
2. Presence of risk associated hereditary germline mutation/s
3. Obesity
4. Type 2 diabetes
5. Hx infectious diseases (HPV, hepatitis B or hepatitis C viruses)
6. Documented / significant exposure to specific chemicals or carcinogens

What are the benefits of a Trucheck™ analysis?

For Trucheck™, only a simple blood test is necessary. Cancers may be detected that are undetectable by present standard methods. An earlier detection of cancer is associated with greater rates of successful treatment.

What are the risks of a Trucheck™ analysis?
The knowledge of being at risk or having cancer, even it is at an early stage, may have significant psychological impact on patients.
Patients should be aware that they may still need to undergo regular screenings based on established guidelines as Trucheck™ is not intended to replace standard cancer screenings.