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In Brief This Week: Devyser Diagnostics, MGI Tech, Molecular Instruments

NEW YORK – Swedish genetic test developer Devyser Diagnostics said this week that it has received Medical Device Single Audit Program (MDSAP) certification for its quality management system (QMS) for its assays and software in Brazil. MDSAP enables a single audit to satisfy QMS requirements of participating regulatory agencies, including the US Food and Drug Administration, among others, Devyser said, adding that the certification could potentially accelerate commercialization of approved products. 

MGI Tech said this week that it has opened a customer experience center in Brazil, adding to eight other such centers around the world. Located in Brooklin Paulista in São Paulo, the new center will provide demonstrations of MGI's technologies, train users, and support applications. It will showcase MGI's next-gen sequencing platforms, sample prep automation systems, and bioinformatics products. In addition, it will serve as a hub for the company to expand its operations in Latin America, where it has been active since 2019.

Molecular Instruments recently announced comarketing agreements with Indica Labs and HistoWiz. Under the terms of the deal with Indica, Molecular's HCR imaging technology is now compatible with Indica's Halo software. The HCR RNA-ISH product provides mild sample preparation with no protease digestion, and native integration with existing IHC/IF workflows. Using Halo modules, researchers will be able to analyze chromogenic and fluorescent HCR RNA-ISH images and perform AI-based quantitative analysis on whole-slide images, Molecular Instruments said.

In the meantime, the firm will integrate HistoWiz's automated histology and digitized pathology solutions with HCR products, providing scientists with clinical-grade capabilities for their in situ hybridization (ISH), immunochemistry, and immunofluorescence assays. Each firm will have access to the other's products and services, and HistoWiz is now a qualified service provider of HCR services and will use HCR imaging technology in its ISH services. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.