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The company's Lyo-Ready 1-Step RT-qPCR mix is being used by diagnostic labs in China to develop screening assays for the virus.
The agency plans to make test kits available to state and international partners in the next two weeks. It also provided updated information about the virus.
The firm presented the results of an internal validation study earlier this month at a conference, which applied the amplicon-based tool in hematological cancers.
Mere weeks after the 2019-nCoV sequence was released, firms, agencies, and research groups have already created PCR-based tests.
The reagent is used for the detection of cytokeratin 19 mRNA in surgically removed sentinel lymph nodes in order to diagnose lymph node metastasis.
Kindstar has also agreed to purchase Genesis systems for use by its scientists to monitor circulating tumor cells and for single-cell research.
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
The firms have agreed to develop infectious disease and women's heath testing assays using SpeeDx's proprietary technology.
To market its analyte specific reagents, syndromic enteric panels, and other tests, the firm is building a US-based sales organization.
The new firm will offer target enrichment assays for clinical NGS testing and develop library preparation kits for clinical tests on Illumina's sequencing platform.