DiaSorin Molecular, LLC announced today that the company has earned CE-IVD certification extending the sample claims for its Simplexa™ HSV 1 & 2 Direct Assay. The certification adds – cutaneous and mucocutaneous lesion swabs – to previously cleared specimen types of cerebrospinal fluid (CSF) and genital lesion swabs.
DiaSorin Molecular
DiaSorin Molecular today announced the U.S. introduction of the SimplexaTM C. difficile Direct Assay, upon receiving clearance from the Food and Drug Administration.
The new assay runs on the company’s LIAISON® MDX system, a scalable benchtop PCR instrument that delivers qualitative and quantitative, sample-to-answer, multi-analyte results. The Simplexa assay detects the Clostridium difficile toxin B gene (tcdB), present in liquid or unformed stool samples, aiding in the diagnosis of C. difficile infection.
DiaSorin Molecular
DiaSorin Molecular launches a new CE-IVD molecular diagnostic test, Iam CBFB-MYH11 (not available in the USA) for the ultra-rapid identification of one of the most common genetic causes of Acute Myeloid Leukemia (AML). This new early diagnosis will aid effective stratification of patient risk, facilitating timely and effective implementation of therapy for patient management improvement.
DiaSorin Molecular