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DiaSorin Molecular Introduces Two Primer Pair Reagents for Streptococcus

DiaSorin Molecular introduces two primer pairs – group C and group G Streptococcus – for use in laboratory-developed molecular tests. These new offerings join DiaSorin’s menu of more than 60 molecular reagents for bacterial, viral and fungal targets in addition to human genetic mutations.

DiaSorin Molecular Introduces Primer Pair Reagent for Pneumocystis jirovecii

DiaSorin Molecular announces the expansion of its menu of molecular reagents with the introduction of a P. jirovecii primer pair for use in laboratory-developed molecular tests.

This analyte-specific reagent (ASR) can be used for the amplification and detection of the Pneumocystis jirovecii mtLSU gene with a CFR610- and BHQ-2-labeled probe and forward and reverse primers. This is DiaSorin’s first fungal infectious disease target.

Extended CE-IVD Certification Expands Sample Claim for DiaSorin Molecular’s Simplexa HSV 1 & 2 Kit

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 Receives FDA Clearance for Reliable C. difficile Assay on LIAISON® MDX Platform

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 launches IAM CBFB-MYH11, completing the diagnostic test menu for molecular screening of acute myeloid leukemia by Q-LAMP.

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.