Trucheck Prostate  – Prostate Cancer Screening Test

Prostate Cancer often has no symptoms until the disease is advanced, and screening may help detect cancer early, when the chances of treatment success are high. Trucheck™ – Prostate is a revolutionary prostate cancer screening test, based on a simple blood draw, for early detection of Prostate Cancer in asymptomatic individuals. Trucheck Prostate is now available in the UK.

Why Early Detection of Prostate Cancer?

Prostate cancer screening with PSA (Prostate Specific Antigen) is not recommended as Standard of Care owing to limitations of PSA (low specificity). However, the TrucheckTM-Prostate is a blood based non-invasive screening with high sensitivity and specificity which accurately identifies individuals with an underlying malignancy of the prostate.

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.

What are the Advantages of the Truecheck Prostate Screening Test?

Advantages to the individuals:

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

Advantages to the system:

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

Why should I consider Trucheck™ Prostate?

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™ – Prostate is Accurate

The development of Trucheck™ – Breast included extensive Analytical and Clinical validation studies to establish its Accuracy and Reliability.
Trucheck™ –

Advantages 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. Late stage survival is 22% compared with 100% for 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.

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 men with and without prostate cancer, Trucheck Prostate will correctly identify 85.6% of those who DO have prostate 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 men with and without prostate cancer, Trucheck Prostate will correctly identify 99.9% of those cases who DO NOT have prostate cancer. This is better than the PSA test.

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 Prostate test shows a high probability of a man having prostate cancer, then there is a 99.9% chance that they WILL actually have breast prostate. This is better than the PSA test.

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 Prostate test shows a low probability of a man having prostate cancer, then there is a 99.9% chance that they WILL NOT have prostate cancer. This is better than the PSA test.

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)