For Non-Invasive Diagnostic Triaging of Suspected Prostate Cancer Patients

A Breakthrough Non-invasive Blood-based test that Detects Prostate Cancer in Symptomatic Individuals with High Accuracy to Save Lives and Preserve Quality of Life.

 

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For Non-Invasive Diagnostic Triaging of Suspected Prostate Cancer Patients

A Breakthrough Non-invasive Blood-based test that Detects Prostate Cancers in Symptomatic Individuals with High Accuracy to Save Lives and Preserve Quality of Life.

 

UK - National Institute for Health and Care Excellence (NICE) Issues MedTech Innovation Briefing on 'Trublood®- Prostate' for Precision Non-invasive Prostate Cancer Diagnosis Described by Experts as a 'Game Changer'

A New Paradigm in Prostate Cancer
Diagnosis with a Simple Blood Test.

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    Indications for Use:
    Trublood® - Prostate is indicated for use in the following cases:

  • Individuals with elevated PSA or suspicious findings on DRE who have been advised an invasive prostate biopsy to check for prostate malignancy
  • Individuals where a recent invasive biopsy has been inconclusive or inconsistent with clinical observations
  • Known cases of prostate cancer with suspected metastatic relapse to rule out a new primary

Trublood® - Prostate detects prostate-specific Circulating Tumor Cells (CTCs) and CTC clusters, which are present in the blood of individuals with prostate cancer and undetectable in healthy individuals or patients with benign prostate conditions.

Executive summary

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What?
Trublood® - Prostate is a non-invasive, blood based liquid biopsy for diagnostic triaging of individuals with prostate related symptoms who may be referred for a Prostate Biopsy.

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For Whom?
For males presenting with either of the following symptoms, who are suspected of Prostate cancer and desire a risk-free triaging for prostate biopsy:
Enlarged prostate
Elevated serum PSA level
Any other urological symptoms

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Why?
Globally, ~75% of all prostate conditions are benign. However, an invasive prostate biopsy is often required to discern benign and malignant prostate conditions. Invasive biopsies are expensive, inconvenient, often painful and risk-prone procedures. Since the biopsies are performed post-referral in a tertiary care centre, they necessitate patient travel to these centres and may involve wait times. In some cases, Prostate biopsies may be unviable due to comorbidities. On the other hand, Trublood® - Prostate requires only a blood sample which can be collected from the privacy and convenience of a patientʼs home or office.

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How?
Patient's blood sample is evaluated for the detection of Prostate Cancer associated Circulating Tumor Cells (CTCs). Such CTCs are undetectable in blood samples of individuals free of prostate cancer.

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Analytes
Circulating Tumor Cells
(CTCs)

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Tests
Immunocytochemistry

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Turnaround time
10 days

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Sample type
About 15 ml venous blood

Challenges

A large numer of expensive, risk-prone prostate biopsies are performed every year globally, of which about 75% turn out to be benign. Thus a disproportionate number of symptomatic males undergo an invasive procedure that is retrospectively deemed as avoidable or unnecessary.

Advantages of Trublood®

Trublood® Prostate can identify individuals with Prostate cancer associated CTCs who can then be prioritised for further clinical procedures such as biopsy. Individuals who test negative can be considered for a later evaluation.
Adoption of Trublood® Prostate can eliminate or significantly reduce the number of unnecessary prostate biopsies each year and alleviate the financial and logistical burden on cancer management infrastructure.
Trublood® Prostate is patient-friendly since it eliminates or significantly reduces the number of symptomatic individuals to be exposed to risks of pain and procedural complications. Trublood® Prostate has been validated for detection of Prostate Adenocarcinomas (AD) which account for >95% of all Prostate Cancers.

Precautions

Trublood® Prostate does not discern between Ductal and Acinar subtypes of Prostate AD.
Trublood® Prostate is not intended for determination of Gleason Score / Grade.
Trublood® Prostate can detect an underlying Squamous Cell Carcinoma or Neuroendocrine Tumor which may be associated with the Prostate or another primary organ. Appropriate ruleout investigations may be necessitated in case of such findings.
Trublood® Prostate has not been validated for detection of rarer subtypes such as basal cell carcinomas.
Trublood® Prostate is intended to be used in conjunction with Standard of Care Prostate Cancer Diagnostic Workup.
Trublood® Prostate findings must be interpreted and used by a Qualified Physician in conjunction with other clinical findings.

Illustrative Immunocytochemistry Images

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Trublood® Prostate identifies individuals who must be considered for Prostate biopsies and those who can be excluded

Validation

Trublood® non-invasive diagnostic biopsy for solid organ cancers has been developed by Datar Cancer Genetics based on the findings of two clinical trials registered with the CTRI (Registration Nos. CTRI/2019/01/017219 and CTRI/2019/03/017918).

Trublood® has been extensively validated with data from more than 22,000 samples from asymptomatic individual donors as well as more than 18,000 samples from patients with various cancers/patients with benign conditions, totalling more than 40,000 evaluable samples till December 2019.

Analytical Validation

Parameter Performance Characteristics
Sensitivity 90.00% (76.34% - 97.21%)
Specificity 100.00% (88.43% - 100.00%)
Accuracy 94.29% (86.01% - 98.42%)
Precision 5.6% CV
Parameter Performance Characteristics
Robustness >90%
Linearity R2 >0.99
Limit of Detection 1 cell / mL

Clinical Validation

Parameter Prostate Cancer (90) v/s
Benign Prostate conditions (289)
Prostate Cancer (90) v/s
Asymptomatic Individuals (3,898)
Sensitivity >99% (95.9% - 100%) >99% (95.9% - 100%)
Specificity 99.3% (97.6% - 99.92%) 99% (97.5% - 99.99%)
Positive Predictive Value 98.03% (92.58% - 99.50%) 100.00% (-)
Negative Predictive Value 100.00% (-) 100.00% (-)
Accuracy 99.50% (98.20% - 99.94%) 100.00% (99.90% - 100.00%)
Parameter Prostate Cancer (90) v/s
Benign Prostate conditions (289)
Sensitivity 100.00% (96.41% - 100.00%)
Specificity 99.33% (97.60% - 99.92%)
Positive
Predictive Value
98.03% (92.58% - 99.50%)
Negative
Predictive Value
100.00% (-)
Accuracy 99.50% (98.20% - 99.94%)
Parameter Prostate Cancer (90) v/s
Asymptomatic Individuals (3,765)
Sensitivity 100.00% (96.41% - 100.00%)
Specificity 100.00% (97.90% - 100.00%)
Positive
Predictive Value
100.00% (-)
Negative
Predictive Value
100.00% (-)
Accuracy 100.00% (99.90% - 100.00%)

For Patients

Ask Your Doctor


Our patient's downloadable content has all the information you and your doctor need to discuss Trublood® Prostate testing.