▷ National Institute for Health and Care Excellence (NICE) in Großbritannien …

14.07.2021 – 13:54

Datar Cancer Genetics Ltd

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:

 - "An Trublood®-Prostate ist innovativ, dass ein Immunzytochemie-Profiling (ICC) verwendet wird, um für das Prostata-Adenokarzinom spezifische zirkulierende Tumorzellen (CTCs) zu charakterisieren, die aus dem Blut von Patienten isoliert wurden. 
 - Zum Einsatz käme der Test entweder bei der Triage von symptomatischen Patienten mit Verdacht auf Prostatakrebs vor der Durchführung einer konventionellen invasiven Prostatabiopsie oder zur Erlangung einer Diagnose bei symptomatischen Personen mit Verdacht auf Prostatakrebs, die aus anderen Gründen nicht für eine Prostatabiopsie geeignet sind, in primären, sekundären und tertiären Einrichtungen. 
 - Trublood®-Prostate ist der erste in-vitro-diagnostische Test, der auf C-ETACS und CTCs basiert, die aus Blutproben isoliert wurden. 
 - Trublood®-Prostate hat das Potenzial, zu einem innovativen, minimalinvasiven diagnostischen Test für den Nachweis von Prostatakrebs zu werden. 
 - Alle Experten waren sich einig, dass der Trublood®-Prostate Test das Potenzial hat, ergänzend zu den Standard-Verfahren bei der Diagnose eingesetzt zu werden. 
 - Die Experten erklärten auch, dass ein Bluttest, der zwischen Männern unterscheiden könnte, die sich einer Biopsie unterziehen müssen oder nicht, oder der es ermöglichen würde, die Diagnose ohne Biopsie zu stellen, ein entscheidender 'Game Changer' in der derzeitigen Versorgung von Prostatakrebs wäre. 
 - Ein Experte betonte die Innovativität der CTCs-Anreicherungstechnik und dass die schnelle Verfügbarkeit von Ergebnissen nach 8 Tagen hilfreich sei. 
 - Ein Experte fügte hinzu, dass der diagnostische Test in Zukunft zusammen mit dem PSA-Test als Präzisions-Screening-Tool für Prostatakrebs eingesetzt werden könnte. 
 - Ein Experte meinte, dass Trublood®-Prostate das Potenzial habe, Menschen mit Serum-PSA-Werten im mittleren Bereich (d. h. zwischen 4 -10) eine präzisere Diagnose zu bieten." 

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.

Press contact:

Dr Vineet Datta – [email protected]
Website: 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

Original content by: Datar Cancer Genetics Ltd, transmitted by news aktuell

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