Qiagen launches first FDA-approved tissue companion diagnostic to identify the KRAS G12C mutation

QIAGEN N.V. today announced the launch of an expanded scope of companion diagnostic claims for the therascreen® KRAS RGQ PCR Kit after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer patients that may be eligible for treatment with LUMAKRASTM , a newly approved therapy developed and marketed by Amgen Inc.

The therascreen KRAS Kit is the first companion diagnostic test to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use to identify the KRAS G12C mutation in samples of NSCLC tumour tissue. KRAS is one of the most frequently occurring mutation in this form of cancer, and is estimated to be present in up to 13% of cases of the disease. Until now KRAS G12C has not been actionable, and in fact had only previously been linked with resistance to therapies. The real-time qualitative PCR kit is used with the Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions, and builds upon QIAGEN’s nine years of experience in KRAS CDx test development and commercialization.

“We are pleased to announce this significant expansion in the scope of FDA-approved CDx claims for the therascreen KRAS Kit” said Jean-Pascal Viola, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “This new approval further expands our market-leading therascreen portfolio of companion diagnostic tests, and illustrates our determination to support the delivery of the latest innovations in precision healthcare to patients with NSCLC, for whom every new treatment option is extremely welcome.”

“With advances in precision medicine, biomarker testing is critical for patients with non-small cell lung cancer because it informs treatment options during the course of their disease. It is important that patients and their healthcare providers know that KRAS G12C is now an actionable mutation and start testing for it,” said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen. “With the approval of QIAGEN’s companion diagnostic for LUMAKRAS, patients and clinicians will have more options and flexibility for biomarker testing.”

Up to 13% of NSCLC-patients may have KRAS G12C positive tumours and hence be potentially eligible for treatment with LUMAKRASTM. To accelerate identification of these patients, following the FDA approval of this test QIAGEN is making testing of NSCLC tumour tissue samples with the therascreen KRAS Kit available immediately at leading laboratories across the U.S, through QIAGEN’s Day-One Lab Readiness program for Precision Medicine.

QIAGEN’s therascreen KRAS Kit was used to support the CodeBreaK 100 clinical trial of sotorasib and the expansion of the Kit’s CDx claims to include identification of the KRAS G12C mutation in NSCLC samples has been co-approved with LUMAKRAS by the FDA. The Amgen drug is a new inhibitor of the G12C-mutated form of the KRAS (Kirsten rat sarcoma) protein, and is the first-in-class drug approved for treatment of this form of cancer. Further details about the Kit are available at www.qiagen.com/KRAS.

QIAGEN’s Day-One Lab Readiness program builds on the FDA’s modernized regulatory approach to benefit patients by accelerating the launch of advanced diagnostics. An updated list of U.S. laboratories offering testing of NSCLC samples for the KRAS G12C mutation using the therascreen KRAS test is available at www.qiagen.com/KRAS-lab-finder.

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 now has ten PCR based companion diagnostic indications 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. The therascreen KRAS Kit co-approval with LUMAKRASTM marks the tenth FDA approval of a therapy partnered with a QIAGEN companion diagnostic assay. Business Wire