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Qiagen to Develop CDx for Clovis Drug Targeting NSCLC

NEW YORK (GenomeWeb News) – Qiagen and Clovis Oncology announced after the close of the market on Monday a partnership to develop a companion diagnostic for a candidate oncology drug being developed by Clovis.

The deal covers the co-development and co-commercialization of the test to guide the use of CO-1686 being developed by Clovis to initially target an unmet clinical need in patients with epidermal growth factor receptor-driven non-small cell lung cancer who no longer respond to EGFR-inhibiting drugs.

The test will build on Qiagen's therascreen EGFR RGQ PCR Kit, which was approved by the US Food and Drug Administration in July for Boehringer Ingelheim's Gilotrif (afatinib) for metastatic non-small cell lung cancer.

Subject to regulatory approvals, Qiagen will develop and globally commercialize the companion diagnostic for Clovis' drug.

In addition to the test for CO-1686, Qiagen and Clovis have signed a master collaboration agreement under which Qiagen's sample and assay technologies may be used to develop other companion diagnostics for Clovis products.

Additional financial and other terms of the deal were not disclosed.

Clovis President and CEO Patrick Mahaffy said in a statement, "Importantly, Qiagen's test is already FDA approved to reliably and accurately detect EGFR mutations, including T790M, which complements our accelerated plan for CO-1686 clinical development by potentially allowing for a supplemental premarket approval filing."