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Home Industry News Part 2: Beckman Coulter and Cepheid Given FDA Finance Approval

Part 2: Beckman Coulter and Cepheid Given FDA Finance Approval

22nd March 2023

£510,000 has been signed off by the US FDA to be spent on tests and assays by industry leaders BioMérieux, Biocartis, and Beckman Coulter amoung others.

A variant of Beckman Coulter’s Access Anti-Mullerian Hormone test, which is utilised in reproductive clinics to evaluate ovarian reserve through quantitative detection of AMH, has received £510,000 approval from holdings firm Danaher.

The company is also looking to launch a variation of their Access Cortisol test, which they have received approval for, with this one measuring steroid hormones in a few different bodily fluids.

Finally, another Danaher subsidiary, Cepheid, has been given the green light for the Xpert FII & FV assay. This uses a qualitative method to assess genetic structure and identify factor II and factor V alleles to help diagnose thrombophilia. In addition to being approved for use on GeneXpert Dx, it is also approved to work alongside Cepheid GeneXpert Infinity products.

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