Datar Cancer Genetics has obtained CE Mark for its non-invasive liquid biopsy cancer diagnostic test.
Named TruBlood, the blood-based test serves as a new paradigm to detect, diagnose, and manage cancer.
Datar Cancer Genetics noted that the certification confirms the solution meets European Medical Devices Directive requirements and enables the use of TruBlood in the UK, EU, and other regions, which accept the CE Mark.
The solution evaluates the presence of tiny clusters of tumour cells (C-ETACS) shown to be highly prevalent in the blood of cancer patients and cannot be detected in individuals without cancer.
The test helps people, presenting to their doctors with suspicious growths in the breast, lung, prostate, colon, and brain, possibly suggestive of malignancies, and those who have been recommended to take a biopsy.
TruBlood can also help to diagnose cases where invasive biopsies are unviable for reasons such as proximity of a tumour to a vital organ or blood vessel, or when patients have co-morbidities.
Mid Essex Health Trust medical oncologist Tim Crook said: “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.”
Datar Cancer Genetics is planning to market TruBlood as a low-risk, patient-friendly diagnostic assessment for clinical care pathways to prioritise patients with detectable C-ETACs for biopsies.
Meanwhile, the patients who test negative for C-ETACs can be considered for later evaluation, using alternative diagnostic procedures.