QIAGEN Partners With Mirati Therapeutics Inc. to Develop KRASG12C Companion Diagnostic for Non-Small Cell Lung Cancer (NSCLC)

QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) today announced a global collaboration with Mirati Therapeutics Inc. (NASDAQ:MRTX) to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRASG12C mutation who may benefit from treatment with adagrasib, Mirati's investigational, highly selective and potent oral small molecule inhibitor of KRASG12C.

The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer (NSCLC), and allows for further development of tests for other Mirati oncology programs.

The planned companion diagnostic would expand upon QIAGEN's therascreen KRAS testing portfolio based on real-time qualitative PCR for the QIAGEN Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions, and builds upon the Company's nearly decade of experience in KRAS companion diagnostic test development and commercialization. QIAGEN and Mirati have previously partnered for the development of a companion diagnostic.

"We are pleased Mirati recognizes the success of QIAGEN's therascreenplatform and continues to partner with us to develop a tissue-based companion diagnostic to identify patients who may benefit from adagrasib. QIAGEN's experience and expertise in developing diagnostic solutions for Precision Medicine are well-suited to evaluate patients with non-small cell lung cancer," said Jean-Pascal Viola, Senior Vice President and Head of QIAGEN's Molecular Diagnostics Business Area. "Our collaboration with Mirati is a demonstration of QIAGEN's capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics."

The therascreen-based companion diagnostic detects KRASG12C, a genetic mutation that is one of the most common KRAS alterations linked to cancer. The RAS gene family is the most frequently mutated oncogene in human cancer, with KRAS being the most prevalent driver mutation in NSCLC.

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has nine PCR based companion diagnostics that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates - a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients. QIAGEN is partnering with Illumina to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.