CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Paige announced a month earlier, in May, that it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, designed to assist in the detection of androgen receptor, TP53, RB1, and PTEN biomarkers. The Paige Prostate Biomarker Suite was developed using the same underlying technology from Paige Prostate Detect, which was developed with histology image data from tens of thousands of patients and was already CE-IVD and UKCA marked and approved by the Food and Drug Administration.
Sysmex receives FDA clearance for residual WBC counting
Sysmex America has received FDA clearance for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode. This is the first automated hematology analyzer to be FDA cleared for residual WBC counting. The latest analyzer supports red blood cell and platelet component testing along with residual white blood cell counting in a single sample aspiration.
The XN-10 with Blood Bank mode features analysis of blood components with four different selectable profiles: two profiles for RBC concentrates and two for platelet concentrates.
Available as a single module (XN-1000BB) or twin co-primary analyzers (XN-2000BB), the scalable hematology analyzer may be installed as a tabletop analyzer or placed on wagons, and either model may be made even more efficient with the addition of the RU-20 reagent unit, the company said in its June 15 press release.