NEW YORK ─ Datar Cancer Genetics on Wednesday announced it has received CE marking for a liquid biopsy-based cancer diagnostic test, enabling its use in the UK, European Union, and other regions that accept the designation.
The test, called TruBlood, evaluates the presence of tiny clusters of circulating tumor cells shown to be highly prevalent in the blood of cancer patients and undetectable in people without cancer, the firm said.
The test can be used to evaluate people who present with suspicious growths in the breast, lung, prostate, colon, or brain and have received a recommendation to obtain a conventional biopsy, Datar Cancer Genetics added. The blood test can also help to diagnose cases where conventional biopsies are unviable for reasons such as the proximity of a tumor to a vital organ or blood vessel, and when patients have co-morbidities.
TruBlood technology has been developed by evaluating more than 40,000 blood and tumor samples from about 22,000 cancer patients, the company said.
Nasik, India-based Datar Cancer Genetics said it intends to market TruBlood for the prioritization of patients for conventional biopsies when they have detectable tiny clusters of circulating tumor cells. Patients who test negative can be considered for subsequent evaluation using alternative diagnostic procedures.