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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