The US Food and Drug Administration (FDA) has now also granted our blood test for the diagnosis of CNS tumours a “Breakthrough Device Designation”. Following our blood tests for the early detection of prostate and breast cancer, this is the third test to receive this designation from the FDA.
If tumours are considered inoperable or inaccessible, this liquid biopsy is intended to support diagnosis by means of a simple blood test and thus meet a previously unmet clinical need.
A prospective, blinded study was conducted at Imperial College London to provide clinical evidence. In two case-controlled studies, a 98% sensitivity and specificity in the detection of malignant brain tumours and in the differentiation between malignant and benign CNS diseases was established.
The test is CE-certified and is already available to patients under the name “Trublood CNS”.
You can find a more detailed article on this topic here: https://www.pressebox.de/pressemitteilung/datar-cancer-genetics-europe-gmbh/us-zulassungsbehoerde-fda-erteilt-weitere-breakthrough-device-designation-fuer-bluttest-zur-diagnose-von-unzugaenglichen-zns-tumoren/boxid/1141185