Non-invasive liquid biopsy gets CE certification, to help cancer diagnosis

Datar Cancer Genetics 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 commercialise 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 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, 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.