Company Announcements

Agena Bioscience and Simcere Diagnostics, a subsidiary of SIMCERE Pharmaceutical, signed in March a strategic partnership agreement focusing on expanding the use of Agena’s MassARRAY System for companion diagnostics and pharmacogenetic testing in China. In April, the US FDA authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients. The FDA permitted marketing for a new use of the BRUKER MALDI Biotyper CA system for the identification of C. auris, adding to the system’s already cleared uses for the identification of 333 species or species groups, covering 424 clinically relevant bacteria and yeast species. The FDA also plans to propose to exempt certain MS microorganism identification system processes from an additional premarket review after a system process receives a first-time FDA marketing authorization. Freenome, developer of an AI genomics platform, announced in April a collaboration with Biognosys to advance early-cancer detection and precision oncology. Biognosys adds protein quantification to Freenome’s use of its AI genomics platform for the analysis of cfDNA and cfRNA in the development of a screening test. In April, University of Michigan’s Brandon Ruotolo and Kristina Hakansson received an Agilent Thought Leader Award. The Award provides three years of financial assistance as well as instrumentation to support their research into understanding the structure and function of proteins and protein complexes using MS. In May, Microsaic Systems entered into a distribution agreement with Rightek for Taiwan. Microsaic announced in May a distribution agreement with Stable Arm for Malaysia.  

Product Introductions

VICAM, a Waters business, released in March the VICAM BPATest for determination of Bisphenol A (BPA) by food and agricultural laboratories. The immunity chromatography–based test quickly isolates and purifies BPA for analysis from 0.1 to 50 ppb in as little as 10 minutes total preparation time. In May, Waters launched the DART (Direct Analysis in Real-Time) QDa System with Live ID for rapid molecular fingerprinting of food and food ingredients. The system performs real-time sample recognition and verifies sample authenticity or adulteration. Live ID software provides the user with the capability to train and validate multivariate statistical models. It is expected to begin shipping in July. The product is a collaboration with IonSense, which provided the DART. Caymen Chemical launched in April MaxSpec analytical standards, a new line of ready­-to-­use, quantitative lipid standards prepared specifically for MS applications. More than 30 standards are currently available. In May, Bruker debuted the integrated Bologna Workflow, a diagnostic workflow solutions for rapid and cost effective microbial identification and antibiotic resistance testing from positive blood cultures based on existing Bruker kits and instrumentation. The company also launched new kits for the workflow: the new, simplified Fast Sepsityper, the CE-IVD marked MBT STAR-Cepha kit for functional resistance testing against third generation cephalosporins, and a MALDI Biotyper reference library update that adds another 239 species across 24 microbial genera. MS software firm Protein Metrics introduced in May the Byos platform, which automates biotherapeutic characterization workflows with just one click. Byos template workflows allow XIC (eXtracted Ion Chromatogram) feature comparison with MS/MS IDs for post translational modification, host cell proteins, disulfide bonds and sequence variance analysis. In May, SCIEX introduced BioPharmaView Software 3.0, a complete MAM (Multiple Attribute Methodology) workflow in a single software suite, along with the ability to automate core biologics characterization workflows, such as intact mass, subunit mass and peptide mapping analyses. Biognosys released in May the PQ500 Reference Peptide Kit consisting of more than 800 stable isotope–labelled standard peptides. PQ500 enables absolute quantification of more than 500 human plasma proteins through the combination of the quantitative capabilities of MRM/PRM with the comprehensiveness of DIA.

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