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

MIBs are published as "NICE advice" series to U.K. National Health Service (NHS) hospitals and clinical commissioning groups / payers who are considering using innovative technologies. The NICE briefing highlights the following:

• "The innovative aspects are that Trublood(R)-Prostate uses immunocytochemistry (ICC) profiling to characterize Prostate Adenocarcinoma specific Circulating Tumor Cells (CTCs) isolated from patients' blood.
• The intended place in the care pathway would be either to triage symptomatic patients suspected of prostate cancer prior to undergoing a conventional invasive prostate biopsy or to obtain a diagnosis in symptomatic people suspected of prostate cancer who are otherwise unfit for a prostate biopsy in primary, secondary and tertiary settings.
• Trublood(R)- Prostate is the first in vitro diagnostic test based on C-ETACS and CTCs isolated from blood samples.
• Trublood(R)-Prostate has the potential to become an innovative, minimally invasive diagnostic test for detecting prostate cancer.
• All experts agreed that the Trublood(R)-Prostate has the potential to be used in addition to standard of care procedures.
• Experts also said that a blood test that could discriminate between men who do or not need to undergo biopsy or allow the diagnosis to be made without biopsy would be a game changer in the current care of prostate cancer.
• One expert said that the innovative aspect is the CTCs enrichment technique and that the 8 days turnaround is a useful feature.
• One expert added that in the future the diagnostic test could be used together with PSA as a precision screening tool for prostate cancer.
• One expert said that Trublood(R)-Prostate has the potential to increase the diagnostic precision for people with serum PSA values in the intermediate range (i.e. between 4 -10)."

Trublood(R)-Prostate is a non-invasive, blood-based liquid biopsy for diagnostic triaging of individuals with an elevated risk of prostate cancer. It detects Prostate-speci?c Circulating Ensembles of Tumor Associated Cells (C-ETACs), which are ubiquitous in the blood of individuals with prostate cancer and undetectable in healthy individuals or patients with benign prostate conditions. It has an accuracy of 99.50% to detect Prostate Adenocarcinoma, a sensitivity of 100% and a specificity of 99.33%. The test will be available from August 2021 at about Euro 810.

Over 4.4 million prostate biopsies are performed annually worldwide. Of these, approximately 75% of cases of prostate cancer are retrospectively deemed unnecessary because of confounding benign prostatic conditions. Thus, approximately 3.3 million of all prostate biopsies are avoidable. Prostate biopsies are not free from procedural risks and precise diagnosis before any biopsy would be easy on the patient. Reduction in number of biopsies also indicates a significant reduction of burden on the cancer management expenses and infrastructure, reduced waiting times and reduced referrals. 

Dr Tim Crook, Medical Oncologist, Broomfield Hospital, Chelmsford (UK) said that "Trublood(R)-Prostate is an innovative, non-invasive test for prostate cancer that offers unprecedented sensitivity and specificity without the risks and morbidity associated with tissue biopsy. The utility of Trublood(R)-Prostate clearly demonstrates the potential of CETAC-based technology for the early detection of multiple other cancer types with implications in cancer diagnosis and screening".

Dr Vineet Datta, Executive Director, Datar Cancer Genetics, stated "We are excited to see the NICE MIB on the use of Trublood(R)-Prostate. NICE is considered to be the world's leading authority in evaluating innovative medical technologies and uses rigorous processes for assessment for both clinical and economic outcomes. We are extremely proud that Trublood(R)-Prostate is recognized as an innovation for better management of suspected prostate cancer. This briefing will help healthcare decision-makers in the United Kingdom and worldwide to consider the adoption of Trublood(R) for more efficient management of symptomatic individuals. We remain fully committed to meeting absolute quality standards and pushing innovation in non-invasive diagnostic techniques for difficult to biopsy cancers."

About Datar Cancer Genetics

Datar Cancer Genetics is a leading cancer research company specializing in non-invasive techniques for better diagnosis, treatment decisions, and management of cancer. Datar Cancer Genetics has a state of art, College of American Pathologists (CAP), CLIA, ISO15189, ISO9001 and ISO27001 accredited facility. The Company has operations in the United Kingdom, Germany and India.

Contact: Dr Vineet Datta - [email protected]  

Website: datarpgx.com

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