+37068508903

info@trucheck.lt

Linkedin
Register for the test

+37068508903

info@trucheck.lt

Linkedin
Register for the test

Early Cancer Screening​

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

The following options are available:

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

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.
  • In clinical studies, Trucheck™ has a sensitivity of 88% in the detection of cancer at all stages and types. Further Trucheck™ intelli has an accuracy of 96% in determining the tissue or organ of origin in positive cases.
  • Real-world data has shown a sensitivity, depending on the tumor, of 65% – 89% and a specificity of 96% – 99%.
  • Trucheck™ detects cancers irrespective of the extent of the disease, thus even early-stage cancers are reliably observed.

Trucheck™ is particulary 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.

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

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.
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.

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

Requirements:

Blood draw:
3 EDTA tubes (purple colour cap) – 2 x 10 ml and 1 x 6 ml – in total: 26 ml

Note
Sequence of draw should not be altered. 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:

  • Blood sample must be collected following a 6 hour fasting period. Consumption of fluids is permitted.
  • All 4 pages of the Test Request Form (TRF) are to be read and completed by the patient and the doctor. Please provide location, date and signature in all relevant places.

 

Turn Around Time
10 days from receipt of sample

UAB Labmed
Company code 111475280

Contacts

info@trucheck.lt
+37068508903

Linkedin

RESEARCH

INFORMATION

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