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Biolidics ClearCell FX1 System Gets China NMPA Approval

NEW YORK – Biolidics said today that its ClearCell FX1 System has obtained a Class I registration from the China National Medical Products Administration.

ClearCell FX1 is a liquid biopsy platform that separates and enriches cancer cells from a blood sample for either quantitation or further analyses like molecular and genomic profiling.

With the NMPA approval, Biolidics can now directly market and sell the platform to hospitals, laboratories, research institutions, and other medical institutions for use in in vitro diagnostic testing.

According to the company, the FX1 is being explored in laboratory-developed test collaborations by several organizations in China, including the Agen Medicine Laboratory Technology Company, TopGene Medical Laboratory Company, Genecast Biotechnology, and the Holistic Integrative Pharmacy Institute at Hangzhou Normal University.