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Clovis Oncology (NASDAQ: CLVS) announced today that the Company signed an agreement with QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) to develop a companion diagnostic test to identify the T790M resistance mutation in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for CO-1686.
The diagnostic will build on QIAGEN’s
therascreen® EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a companion diagnostic used in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the
therascreenEGFR test has been established for 21
EGFR mutations, including the most prevalent resistance mutation (T790M). Terms of the agreement were not disclosed.
“As we continue development of CO-1686 for patients with mutant EGFR-driven non-small cell lung cancer, we are pleased to collaborate with QIAGEN for the development of a companion diagnostic for CO-1686,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “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 (PMA) filing.”
“We are pleased that Clovis has selected the
therascreen EGFR test as its companion diagnostic solution of choice for CO-1686,” said Peer M. Schatz, QIAGEN’s Chief Executive Officer. “The decision provides further confirmation for the
therascreen technology’s leadership in companion diagnostics. We look forward to working with Clovis to contributing the benefits of personalized healthcare to all stakeholders involved: for pathologists, oncologists, payers and – most importantly – for patients.”
The diagnostic test is now being further developed in parallel with the clinical development of CO-1686, with the goal of filing a supplemental PMA application with the FDA in a time frame that would allow for regulatory approval of the companion diagnostic concurrent with CO-1686 approval. The Company intends to begin using the QIAGEN test in its Phase II expansion cohorts, the first of which is expected to begin enrolling in late 2013.