London (ots/PRNewswire) Datar Cancer Genetics, a global leader in non-invasive cancer analysis and diagnostics with a research center in Nasik, India, has announced the publication of the internationally recognized MedTech Innovation Briefing (MIB) from the UK National Institute for Health and Care Excellence (NICE) for its CE-marked “Trublood®-Prostate” test announced. The test is intended to be used for the precise grading of patients without unnecessary invasive biopsies.

MIBs are published as part of the “NICE advice” series for hospitals and clinical contractors / payers of the National Health Service (NHS) in the UK considering the use of innovative technologies. The NICE briefing highlights the following:

  • “What is innovative about Trublood®-Prostate is that immunocytochemistry profiling (ICC) is used to characterize circulating tumor cells (CTCs) specific for prostate adenocarcinoma that have been isolated from the blood of patients.
  • The test would be used either to triage symptomatic patients with suspected prostate cancer prior to performing a conventional invasive prostate biopsy or to obtain a diagnosis in symptomatic persons with suspected prostate cancer who are not suitable for prostate biopsy for other reasons in primary, secondary and tertiary institutions.
  • 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 the detection of prostate cancer.
  • All experts agreed that the Trublood®-Prostate Test has the potential to be used in addition to the standard diagnostic procedures.
  • The experts also stated that a blood test that could differentiate between men who may or may not have to undergo a biopsy, or that would allow a diagnosis to be made without a biopsy, would be a critical game changer in current prostate cancer care .
  • One expert emphasized the innovative nature of the CTCs enrichment technique and that the quick availability of results after 8 days is helpful.
  • One expert added that in the future, the diagnostic test could be used along with the PSA test as a precision screening tool for prostate cancer.
  • One expert suggested that Trublood® prostates have the potential to provide a more precise diagnosis for people with serum PSA levels in the middle (ie between 4 -10). “

Trublood®-Prostate is a non-invasive, blood-based fluid biopsy for diagnostic tests of people with an increased risk of prostate cancer. It detects prostate-specific ensembles of tumor-associated cells (C-ETACs), which are ubiquitous in the blood of people with prostate cancer and cannot be detected in healthy people or patients with benign prostate diseases. It detects prostate adenocarcinomas with 99.50% accuracy, has a sensitivity of 100% and a specificity of 99.33%. The test will be available from August 2021 for around 810 euros.

Over 4.4 million prostate biopsies are performed worldwide every year. Of these, around 75% of prostate cancer cases are retrospectively considered unnecessary because they are benign prostate diseases. Around 3.3 million prostate biopsies would be avoidable. Profitability is not free from procedural risks and an accurate diagnosis before each biopsy would be gentler on the patient. A reduction in the number of biopsies also means a significant reduction in costs and a relief of the infrastructure for cancer management, shorter waiting times and fewer referrals.

Dr. Tim Crook, Medical Oncologist, Broomfield Hospital, Chelmsford, UK, said, “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 benefits of Trublood®-Prostate clearly show the potential of CETAC-based technology for the early detection of several other cancers with corresponding consequences for cancer diagnosis and screening. “

Dr. Vineet Datta, Executive Director, Datar Cancer Genetics, said, “We welcome the NICE MIB on Trublood® Prostate Use. NICE is recognized as the world’s leading authority on the evaluation of innovative medical technologies and uses rigorous processes to evaluate both clinical and clinical We are very proud to have Trublood® Prostate recognized as an innovation for better management of suspected prostate cancer. This briefing will help healthcare decision-makers in the UK and around the world to use Trublood® to manage more effectively symptomatic individuals. We remain committed to absolute quality standards and innovate in non-invasive diagnostic techniques for hard-to-biopsy cancers. “

Information on 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-the-art facility accredited by the College of American Pathologists (CAP), CLIA, ISO15189, ISO9001, and ISO27001. The company operates in the UK, Germany and India.

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Dr Vineet Datta –