UK - NICE Issues MedTech Innovation Briefing on 'Trublood®- Prostate' for Precision Non-invasive Prostate Cancer Diagnosis Described by Experts
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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'
LONDON, July 14, 2021 /PRNewswire=KYODO JBN/ --
Datar Cancer Genetics, a world leading non-invasive cancer analytics and
diagnostics company having its Research Head Quarters at Nasik, India,
announced the publication of the internationally recognized 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 NICE briefing highlights the following:
- "The innovative aspects are that Trublood®-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®- 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 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®-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 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® 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 - drvineetdatta@datarpgx.com
Website: datarpgx.com [https://datarpgx.com/]
Logo:
https://mma.prnewswire.com/media/1572835/Datar_Cancer_Genetics_Logo.jpg
Photo: https://mma.prnewswire.com/media/1572837/Trublood_Prostate_Cancer.jpg
Source: Datar Cancer Genetics
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