TEST:

TruBlood®

The test had 95.9% overall sensitivity (95% CI: 86.0-99.5%) and 92.3% specificity (95% CI: 79.13% to 98.38%) to differentiate PBC (n = 49) from benign conditions (n = 39). The high accuracy of the CTC-based TruBlood test demonstrates its potential clinical application as a diagnostic tool to assist the effective detection of PBC when tissue sampling is unviable or inconclusive.

Conclusions Our results demonstrate sensitivity of this CTC assay (TruBlood® Lung) to provide concordant HPE subtyping in 76.3% of the total evaluable cohort (71/93) and in 93.4% (71/76) of the cases subtyped by CTC assay. Thus, this assay can be useful in patients unable to undergo tissue sampling, to establish a diagnosis and conclude histopathological subtype.

We present a non-invasive approach to the diagnostic stratification of patients presenting with suspicious but non-specific neurocognitive symptoms and hence early detection of glial malignancies. Moreover, immunocytochemistry facilitates the differentiation of GBM from metastatic intra-cranial epithelial cancers.

"Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its blood test to detect early-stage prostate cancer...The test has previously received CE certification and is already available in Europe as 'Trublood-Prostate'. The UK-NICE last year issued a MedTech Innovation Briefing that described the Test as a 'Game Changer'."