QIAGEN Launches First FDA-Approved Tissue Companion Diagnosis to Identify KRAS G12C Mutation in NSCLC Tumors and Expand Precision Medicine Options in Lung Cancer

GERMANTOWN, Md. & HILDEN, Germany – (BUSINESS WIRE) – QIAGEN NV (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of an expanded companion diagnostic (CDx) claims lineup for the therascreen® KRAS RGQ PCR Kit (therascreen KRAS Kit) after receiving regulatory approval from the United States as a companion diagnostic to aid in the identification of patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN).

the therascreen The KRAS Kit is the first companion diagnostic test to obtain pre-market approval from the United States Food and Drug Administration (FDA) for use to identify the KRAS G12C mutation in NSCLC tumor tissue samples. KRAS is one of the most common mutations in this form of cancer and is estimated to be present in up to 13% of cases of the disease. So far KRAS G12C has not been exploitable, and in fact, has only previously been linked to resistance to therapy. The Qualitative Real-Time PCR Kit is used with the Rotor-Gene Q MDx instrument, a member of the modular family of QIAsymphony automation solutions, and builds on QIAGEN’s nine years of experience in KRAS Development and marketing of CDx tests.

“We are pleased to announce this significant extension of the scope of FDA-approved CDx claims for the therascreen KRAS Kit, ”said Jean-Pascal Viola, senior vice president and head of the Molecular Diagnostics business line at QIAGEN. “This new approval further expands our position as market leader therascreen range 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 any new treatment option is extremely welcome.

“With advances in precision medicine, biomarker testing is essential for patients with non-small cell lung cancer because it provides information on treatment options during their disease. It is important for patients and their health care providers to know that KRAS G12C is now a workable mutation and start testing it, ”said Darryl Sleep, MD, medical director 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 patients with NSCLC may have KRAS Tumors positive for G12C and therefore potentially eligible for treatment with LUMAKRASTM. To speed up the identification of these patients, following FDA approval of this test, QIAGEN is performing NSCLC tumor tissue sample testing with the therascreen KRAS Kit available immediately in major laboratories across the United States through QIAGEN’s Day-One Lab Readiness Program for Precision Medicine.

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

QIAGEN’s Day-One Lab Readiness program builds on the FDA’s modern regulatory approach to benefit patients by accelerating the launch of advanced diagnostics. An updated list of US laboratories offering NSCLC sample analyzes for the KRAS G12C mutation using therascreen The 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 information that guides clinical decision-making in diseases. such as cancer. QIAGEN has unparalleled depth and breadth of technologies ranging from Next Generation Sequencing (NGS) to Polymerase Chain Reaction (PCR) for the development of companion diagnostics. QIAGEN now has ten companion PCR-based diagnostic indications that are approved by the FDA, 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 therascreen BRAF Kit for Colorectal Cancer.

Currently, QIAGEN is working through collaborative framework agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a vast pipeline of potential future products to advance precision medicine for the benefit of patients. the therascreen Co-approval of the KRAS kit with LUMAKRASTM marks the tenth FDA approval of a therapy associated with a QIAGEN companion diagnostic test.


QIAGEN NV, a Netherlands-based holding company, is the world’s leading provider of Sample to Insight solutions that enable customers to gain valuable molecular information from samples containing the building blocks of life. Our sampling technologies isolate and process DNA, RNA and proteins from blood, tissues and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to yield relevant and actionable information. Automation solutions combine them into transparent and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in the areas of molecular diagnostics (human health), applied testing (mainly forensic), pharmacy (pharmaceutical and biotechnology companies) and academia (research in life sciences). As of March 31, 2020, QIAGEN employed approximately 5,700 people at more than 35 locations around the world. You can find more information on http://www.qiagen.com.

Forward-looking statement

Certain statements in this press release may be considered forward-looking statements within the meaning of Section 27A of the US Securities Act of 1933, as amended, and Section 21E of the US Securities Exchange Act of 1934, as amended. . To the extent any of the statements contained herein regarding QIAGEN’s products, collaborative markets, strategy or results of operations, including, without limitation, its expected adjusted net sales and results of adjusted diluted earnings, are forward-looking in nature, these statements are based on current expectations and assumptions which involve a number of uncertainties and risks. These uncertainties and risks include, but are not limited to, the risks associated with managing growth and international operations (including the effects of currency fluctuations, regulatory processes and reliance on logistics), variability operating results and classifications of customers, commercial development of markets for our products to academic, pharmaceutical, applied testing and molecular diagnostic customers; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected technological changes; fluctuations in demand for QIAGEN products (including fluctuations due to general economic conditions, level and timing of customer financing, budgets and other factors); our ability to obtain regulatory approval for our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; QIAGEN’s ability to identify and develop new products and to differentiate and protect our products from competitive products; market acceptance of new QIAGEN products and integration of acquired technologies and businesses. For more information, please refer to the discussions in the reports that QIAGEN has filed or provided to the United States Securities and Exchange Commission (SEC).


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