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Fluxion Registers Facility with FDA for Manufacture of IsoFlux System

NEW YORK (GenomeWeb News) – Fluxion Biosciences said today it has registered its South San Francisco, Calif., facility as a medical device facility with the US Food and Drug Administration.

Registration with the agency is required in order to manufacture in vitro diagnostic instruments and kits. Fluxion said it will use the facility to manufacture and distribute its IsoFlux System for circulating tumor cell analysis, which it plans on launching as a Class I medical device for In Vitro Diagnostic use next month.

Of the three medical devices recognized by FDA, Class I devices are subject to the least regulatory control.

IsoFlux is a benchtop instrument that uses a proprietary microfluidic technology to isolate rare cells "with high efficiency." Samples processed with the instrument are optimized for downstream molecular testing such as real-time PCR, next-generation sequencing, and immunoassays, Fluxion said.

In June the firm announced two deals covering the IsoFlux system — one with Stanford aimed at developing CTC assays and another one with Rubicon Genomics to integrate enrichment methods for rare cells.