Datar Cancer Genetics announced the publication of the internationally recognised MedTech Innovation Briefing (MIB) from the United Kingdom's National Institute for Health and Care Excellence (NICE) on its CE marked 'Trublood®- Prostate' test to be used for precision triaging of patients to avoid unnecessary invasive biopsies.
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 briefing highlights the following:
- The innovative aspects are that Trublood®-Prostate uses immunocytochemistry (ICC) profiling to characterise Prostate Adenocarcinoma specific circulating tumour 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.
- The cost of Trublood®-Prostate is £750 per test (excluding VAT). According to one expert, Trublood®-Prostate is likely to be cost effective in the long term by allowing diagnosis of prostate cancer with high sensitivity and specificity from a blood test.
- Trublood®- Prostate is the first in vitro diagnostic test based on C-ETACS and CTCs isolated from blood samples.
- Trublood®-Prostate has the potential to become an innovative, minimally invasive diagnostic test for detecting prostate cancer.
- All experts agreed that the Trublood®-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®-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®-Prostate is a non-invasive, blood-based liquid biopsy for diagnostic triaging of individuals with an elevated risk of prostate cancer.
It detects prostate-speciﬁc circulating ensembles of tumour 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%.
Over 100,000 prostate biopsies are performed annually in the UK.
Of these, approximately 56,000 cases of prostate cancer are diagnosed annually, indicating a detection rate of 56% post biopsy. Thus, approximately 44% of all prostate biopsies are avoidable.
44,000 fewer biopsies would mean a significant reduction in the number of patients who undergo an invasive procedure with several procedural risks.
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 at the Broomfield Hospital, Chelmsford, said that "Trublood®-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®-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®-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®-Prostate is recognised 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® 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."
Source: Datar Cancer Genetics
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