Trucheck Intelli Multi Cancer Screening Test

Trucheck Intelli Multi Cancer Screening Test

Trucheck Intelli from Datar Cancer Genetics is a revolutionary early cancer screening test now available in the UK and Ireland via Innermost Healthcare, based on a simple blood draw, for early detection of multiple cancers.

These include cancers such as Melanoma, Head and Neck Cancer, Salivary Gland Cancer, Thyroid Cancer, Lung Cancer, Breast Cancer, Liver Cancer, Biliary Tract Cancer, Gastrointestinal Cancer, Soft Tissue Cancer and Osteosarcoma, Mesothelioma, Urinary Tract (Kidney Cancer and Bladder Cancer), Gynaecological Cancer, Male Cancer including Prostate Cancer, CNS Cancer, Thymus Cancer, Adrenal Cancer, Skin Cancer.

Being a non-invasive blood-based test, Trucheck™ can minimize the need to visit a healthcare centre – since the blood sample can also be collected from the privacy and comfort of your home.

Early detection of cancer is vital for successful treatment and cure. Late detection invariably leads to intensive and toxic treatments, high treatment costs and treatment failure.

Click here to see a video about Trucheck

What are the Advantages of Trucheck™ Multicancer Screening Test

Advantages to the individuals:

Wait times for appointments are reduced
Minimized risk of COVID exposure
May be assimilated into annual health check-up
No risk of radiation or those associated with invasive procedures

Advantages to the system:

Reduces risk of COVID transmission and exposure of staff
Reductions in avoidable / non-critical appointments
Minimizes procedures that may be retrospectively deemed unnecessary
Supports decision making in conjunction with existing tests / methods

Why should I consider Trucheck™ Multicancer Screening Test?

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.

Trucheck™ Intelli Multicancer Screening Test is Accurate

The development of Trucheck™ Intelli Multicancer Screening Test included extensive Analytical and Clinical validation studies to establish its Accuracy and Reliability.

Advantages of Trucheck™ Intelli Multi Cancer Screening Test Over Conventional Screening

Minimize Procedures – Minimizes procedures that may be retrospectively deemed unnecessary.
Radiation Free – No risk of radiation or those associated with invasive procedures.
Save Time – Reductions in avoidable / non-critical appointments.
Early detection saves lives – late stage survival for most cancers is usually worse than with early stage detection.

Cancer – A Global Perspective

Every year about 18 million women and men are diagnosed with various cancers including carcinomas, sarcomas, neuroendocrine tumors, melanomas. These cancers are also associated with about 9 million deaths. This translates into roughly 34 cancer cases being detected and 18 cancer-related deaths every minute.

Annually, these cancers contribute to:

~4.1 million newly diagnosed cases and 1.8 million deaths in Europe (including the UK).
~2.1 million newly diagnosed cases and 550,000 deaths in the US.
~1.2 million newly diagnosed cases and 760,000 deaths in India.

Due to changes in lifestyle as well as other risk factors, these numbers are likely to increase in the future.

FAQs

1. Does Trucheck detect ‘existence of cancer’ or ‘possibility of cancer’? It 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’ results 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 every negative result.

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.

Click here to download our Trucheck Patient Pretest Information Leaflet

Trucheck Cancer Screening Tests

Trucheck Test Performance

Cancer	Trucheck Sensitivity	Conventional Sensitivity	Trucheck Specificity	Conventional Specificity	Trucheck PPV	Conventional PPV	Trucheck NPV	Conventional NPV	Conventional Screening Test
Breast	88.2%	86.9%	99.9%	88.9%	99.9%	69.6%	99.9%	95.9%	Mammogram
Prostate	85.6%	90.0%	99.9%	19.7%	99.9%	33.9%	99.9%	81.0%	PSA
Colon	82.6%	73-98%	99.9%	89%	99.9%	–	99.9%	–	Colonoscopy/ CT Colonography
Cancer	85.7%		99.9%		99.9%		99.9%

This table compares the clinical performance of the Trucheck test with conventional cancer screening tests for different cancers. The results are based on a blinded prospective study involving 15,441 cancers, 700 benign cases and 13,919 asymptomatic individuals.

What does the DETECTION RATE mean?

The detection rate or sensitivity is the ability to correctly identify those who DO have cancer in a group of people with and without cancer. For example, in a group of women with and without breast cancer, Trucheck Breast will correctly identify 88.2% of those who DO have breast cancer.

What is SPECIFICITY?

This is the ability to correctly identify those that DO NOT have cancer in a group of people with and without cancer. For example, in a group of women with and without breast cancer, Trucheck Breast will correctly identify 88.2% of those cases who DO NOT have breast cancer.

What is the POSITIVE PREDICTIVE VALUE (PPV)?

This is the likelihood that if the test is positive that the individual WILL actually have cancer. For example, when the Trucheck Breast test shows a high probability of a woman having breast cancer, then there is a 99.9% chance that they WILL actually have breast cancer.

What is the NEGATIVE PREDICTIVE VALUE (NPV)?

This is the likelihood that if the result is negative that the individual WILL NOT have cancer. For example, when the Trucheck Breast test shows a low probability of a woman having breast cancer, then there is a 99.9% chance that they WILL NOT have breast cancer.

Reference

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)

What cancers can it detect?

Trucheck™* Intelli has been validated for the detection of following types of malignancies:

Adenocarcinoma (AD: Salivary Duct, Thyroid, Breast, lung, Oesophagus, Stomach, Duodenum,
Jejunum, Ileum, Colon, Rectum, Pancreas, Gallbladder, Bile Duct, Liver, Ovary, Prostate, Uterus);

Squamous Cell Carcinoma (SCC; Buccal Mucosa, Hard Palate, Larynx, Lip, Oral Cavity, Paranasal Sinus, Pharynx, Pyriform Fossa, Retromolar Trigone, Soft palate, Tongue, Tonsil, Oesophagus, Lung, Penis, Cervix, Vulva, Vagina, Anorectal, Skin);

Adenosquamous Carcinoma (ADSC:
Oesophagus, Lung);

Neuroendocrine (NET: Lung, Esophagus, Duodenum, Jejunum, lleum, Thymus, Adrenal, Pancreas, Prostate, Colon, Rectum);

Renal Cell Carcinoma (RCC: Kidney);

Transitional Cell Carcinoma (CC: Bladder, Renal Pelvis, Ureter);

Gastrointestinal Stromal tumors (GIST: Stomach, Duodenum, lleum, Jejunum, Colon, Rectum);

Melanomas (Cutaneous, Mucosal);

Mesothelioma (Plural, Peritoneal);

Sarcomas (Carcinosarcoma, Chondrosarcoma, Leiomyosarcoma, Osteosarcoma, Liposarcoma);

Small Cell Lung Cancer (Lung);

Glioma.

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%