Cytek said that the approval places the company on a path to offering a complete spectral flow cytometry solution — including instruments and reagents — to customers in China.
Rutgers researchers have developed a point-of-care tool that can rapidly assess the sensitivity of tumor cells to cancer drugs without staining or labeling.
The University of Arkansas researchers aim to commercialize the Cytophone platform, in development since 2003, by launching a startup in the next year.
The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.
The test uses proprietary peptide analogs to detect overexpression of a peptide construct that binds to cancer cell membranes in urine or blood samples.
The clearance by the Chinese NMPA means the instrument can be used as a clinical diagnostic tool in hospitals, laboratories, and clinics in China.
Clinical researchers at AACR discussed a wide range of approaches focusing on several different potential use-cases in the detection or assessment of early cancers.
The system is used to automate sample preparation steps for assays that are run on BD's FACSLyric clinical flow cytometer.
For the Evry, France-based company, the grant will support its vision of making its technology available as a platform for running oncology assays.
The agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells.