PR88439

LONDON, March 11, 2021 /PRNewswire=KYODO JBN/ --

    Datar Cancer Genetics, a global leader in non-invasive cancer diagnostics,

has received Conformité Européenne (CE) Mark for its innovative TruBlood

solution, a new paradigm in cancer detection, diagnosis and management.

TruBlood is a blood-based, non-invasive test for diagnostic evaluation of

suspected cases of cancer who have been recommended a biopsy. The CE marking

confirms that TruBlood meets the requirements of the European Medical Devices

Directive. The Datar Group proposes to commercialize the solution across the

United Kingdom, European Union and other CE Mark recognising geographies.

    The TruBlood solution evaluates the presence of circulating, tiny clusters

of tumor cells (C-ETACS) which are shown to be highly prevalent in the blood of

cancer patients and undetectable in individuals without cancer. The test will

greatly help individuals presenting to their doctors with suspicious growths in

the breast, lung, prostate, colon, brain, possibly suggestive of malignancies.

    A large proportion of such suspected cases often have only benign tumors

and thus can be spared risky, often painful, and resource intensive, invasive

conventional biopsies. The innovative blood test can also help in the diagnosis

of cases where invasive biopsies are unviable for various reasons such as

proximity of the tumor to a vital organ or blood vessel or in patients with

co-morbidities.

    The Datar Group intends to offer TruBlood as a low risk, patient friendly

diagnostic assessment for clinical care pathways for prioritising patients with

detectable C-ETACs for biopsies and those negative for C-ETACs can be

considered for a later evaluation or alternative diagnostic measures.

    TruBlood marks a quantum leap forward in cancer diagnostics, and the Datar

Group foresees this non-invasive test to benefit both healthcare providers and

patients by incorporating the latest advances in cancer biology and genomic

technology for increased safety and efficacy. The principal advantages of

TruBlood are that it is non-invasive, does not require hospitalisation and has

excellent specificity and sensitivity.

    Commenting upon the announcement, Dr Tim Crook, Medical Oncologist at Mid

Essex Health Trust said that, "TruBlood is an innovative investigation, which

facilitates diagnosis of multiple types of cancer from a simple blood sample.

It uses cutting-edge genomic analysis to identify cancers with a high degree of

accuracy. TruBlood represents an exciting advance with numerous future

applications in cancer diagnosis."

    Dr Nick Plowman, Medical Oncologist at St Bartholomew's Hospital, London

said that, "Harvesting tumor clusters from peripheral blood is akin to a

non-invasive micro-biopsy of the tumor. Somewhat surprisingly, such circulating

tumour cell (CTC) clusters occur even in the early stages of cancer and the

enrichment technology developed by Datar Cancer Genetics has improved the

detection rates and yields. Evaluation of these cancer cell clusters can

facilitate cytopathological (tissue origin) diagnosis. The test is not only

patient friendly, but it can also follow the cancer's genomic evolution (as

well as its persistence) during therapy."

    Initial data published for the TruBlood test in the International Journal

of Cancer (2019), evaluated blood samples from over 16,000 individuals,

including 5,000 cancer patients and more than 10,000 individuals with no

symptoms of cancer, to demonstrate C-ETACs as a functional hallmark of solid

organ cancers. A subsequent study with landmark data published in 2020 in the

American Cancer Society's journal 'Cancer Cytopathology' shows how a

non-invasive blood test (liquid biopsy) can accurately differentiate between

non-cancerous tumors and cancerous growths; the study was based on a

multi-institutional, international collaborative project involving more than

30,000 participants, including ~9,000 known cases of cancer. Overall, the

development of the TruBlood technology is based on evaluation of over 40,000

blood and tumor samples evaluated from ~22,000 cancer patients.

    About Datar Cancer Genetics

    Datar Cancer Genetics is a leading cancer research corporation specialising

in non-invasive techniques for better diagnosis, treatment decisions, and

management of cancer. The Company's state-of-the-art cancer research centre is

ISO15189, CAP and CLIA accredited.

    Publications

    Title: Circulating ensembles of tumor-associated cells: A redoubtable new

systemic hallmark of cancer.

    Journal: International Journal of Cancer; 146(12): 3485-3494.

    DOI: https://doi.org/10.1002/ijc.32815

    Title: Evaluation of circulating tumor cell clusters for pan-cancer

non-invasive diagnostic triaging.

    Journal: Cancer Cytopathol. 2020 Sep 30.

    DOI: 10.1002/cncy.22366

    Website Publications link: - https://datarpgx.com/publications/

    Website datarpgx.com

    Logo:

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    Source: Datar Cancer Genetics