Datar Cancer Genetics received the CE Mark for its non-invasive liquid biopsy cancer diagnostic test.
Known as TruBlood, the test is a new paradigm for detecting, diagnosing, and managing cancer.
Datar Cancer Genetics noted that certification confirms the solution meets European Medical Devices Directive requirements and enables its use in the UK, EU, and other regions that accept the CE Mark.
The solution evaluates the presence of tiny clusters of tumour cells (C-ETACS), which are found in high abundance in the blood of cancer patients and cannot be detected in individuals without cancer.
Those presenting to their doctors with suspicious growths in the breast, lungs, prostate, colon, or brain, potentially indicative of malignancy, and those who have been recommended to take a biopsy, benefit from this test.
TruBlood can also be used in cases where invasive biopsies are not possible, such as when a tumour is located close to a vital organ or blood vessel, or when a patient has co-morbidities.
Medical oncologist Tim Crook of the Mid Essex Health Trust said: “TruBlood is an innovative investigation, which facilitates the diagnosis of multiple types of cancer using a simple blood sample.
The method uses cutting-edge genomic analysis to identify cancers with a high degree of accuracy. “TruBlood represents an exciting scientific advance that has numerous potential applications in cancer diagnosis.”
Datar Cancer Genetics plans to market TruBlood as a low-risk, patient-friendly diagnostic assessment for clinical care pathways in order to prioritize patients who have detectable C-ETACs for biopsies.
Meanwhile, the patients who test negative for C-ETACs can be considered for later evaluation, using alternative diagnostic procedures.
In 2019 Datar Cancer Genetics (Europe) GmbH has placed its operations in Germany. Datar Cancer Genetics Ltd’s (DCGL) innovative solutions will now be available throughout the European Union, a significant milestone for the organization. Through the DCGL GmbH, DCGL will offer molecular genetic services across Europe. DCGL is one of the leading companies in molecular and genetic analysis.
Stefan Schuster, a specialist in oncology diagnostics, will lead DCGL’s European operations and expand its reach.
Dr Vineet Datta, Executive Director at DCGL, said, “This is a significant step in enhancing our international presence in one of the most important markets.” “We are committed to better serving our customers in Europe, and we will continue to expand our international network.”