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