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Roche to Develop Assay as CDx for Ferring's Infertility Treatment

NEW YORK (GenomeWeb) – Roche will develop an existing assay as a companion diagnostic for Ferring Pharmaceuticals' potential infertility treatment under a deal announced today.

Roche will qualify, validate, document, and seek regulatory approval for its test, the Elecsys AMH assay, for use in combination with Ferring's human cell line-derived recombinant follicle-stimulating hormone, a gonadotrophin in phase III development. The Elecsys AMH assay evaluates anti-Müllerian hormone levels, a measure of a woman's ovarian reserve and her response to infertility treatment with gonadotrophin, Roche and Ferring said.

The assay runs on Roche's cobas electrochemiluminescence immunoassay platform and takes about 18 minutes to produce results, compared to several hours with manual AMH testing, they added. The test would allow physicians to personalize dosing of Ferring's treatment and could improve the predictability of infertility treatment, lowering the burden of treatment for women using assisted reproductive technology for conception.

Financial and other terms of the deal were not disclosed.