Non-Invasive Liquid Biopsy to Help Cancer Diagnosis Gets CE Certification

LONDON,March 11,2021 -- Datar Cancer Genetics,a global leader in non-invasive cancer diagnostics,has receivedConformité Européenne (CE) Mark forits 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.TheDatar Group proposes to commercialize the solutionacross theUnited Kingdom,European Union and other CE Mark recognisinggeographies.

TheTruBlood solution evaluates the presence of circulating,tiny clusters of tumorcells(C-ETACS)which are shown to behighly prevalent in the blood of cancer patients and undetectable in individuals without cancer. The test will greatly help individualspresenting to their doctorswith 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 innovativeblood test can also help in the diagnosis of cases where invasive biopsies are unviable for various reasonssuch 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 aquantum leap forward in cancer diagnostics,and the Datar Group foresees this non-invasive testto benefit both healthcare providers and patients by incorporating the latest advances in cancer biology and genomictechnology for increased safetyand 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 atMid 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 atSt Bartholomew's Hospital,Londonsaid 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 enrichmenttechnology developed by Datar Cancer Genetics has improved the detection ratesand 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),evaluatedblood 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 asa functional hallmark of solid organ cancers. A subsequent study withlandmark data published in 2020in the American Cancer Society's journal 'Cancer Cytopathology' showshowa non-invasive blood test (liquid biopsy) can accurately differentiate between non-cancerous tumors andcancerous growths; the study wasbased 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

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