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QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer

  • therascreen® KRAS RGQ PCR kit approved as a companion diagnostic to aid in identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with KRAZATI® (adagrasib)
  • KRAS mutations in NSCLC reflect a large, underserved patient population with an unmet need for innovative treatment options
  • 4th approval of the kit adds to the existing three therapies already indicated in the label for use in NSCLC and colorectal cancer (CRC)

QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen® KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutic’s drug KRAZATI® (adagrasib) for non-small cell lung cancer (NSCLC).

QIAGEN and Mirati Therapeutics, Inc. (NASDAQ:MRTX), a targeted oncology company, announced their cooperation in May 2021. The tissue based KRAS companion diagnostic assay, which QIAGEN developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI. The drug is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA approved test, who have received at least one prior systemic therapy.

therascreen KRAS is a fast and cost-effective test ensuring physicians receive patient reports in the most efficient and straight forward way to make treatment decisions,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. “This last approval is confirming and strengthening QIAGEN leadership in RAS companion diagnostics.”

“It is critical to expand access to genomic testing for both health care providers and people living with cancer equipping them with meaningful information to inform treatment plans,” said Kenna Anderes, Vice President Translational Medicine & Companion Diagnostics at Mirati Therapeutics. “The partnership with QIAGEN has led to meaningful advancements in the development of KRAS-specific biomarker testing.”

This 4th approval of QIAGEN’s therascreen KRAS RGQ PCR kit adds to the existing 3 therapies already indicated in the label for use in NSCLC and colorectal cancer (CRC). It builds on the company’s experience in KRAS companion diagnostic test development and commercialization, which reaches back more than a decade.

Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies with strong scientific rationale in patients with advanced solid tumors. Lung cancer is one of the world’s most widespread cancers. In 2020, 2.21 million new cases and 1.8 million deaths were recorded worldwide.i The therascreen-based companion diagnostic detects KRAS G12C, a genetic mutation that is one of the most common KRAS alterations linked to cancer. This mutation is estimated to be present in around 13% of NSCLC casesii – and thus the most prevalent driver mutation.

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 is striving to fill the clinical gap for patient access and provide technology platform options to address varying clinical testing requirements for KRAS. These include next-generation sequencing (NGS) for comprehensive genomic profiling and digital PCR via QIAcuity for minimal residual disease monitoring.

With the new approval of therascreen KRAS for NSCLC, QIAGEN has eleven PCR based companion diagnostic indications that are FDA approved – the broadest portfolio of IVD approved PCR based companion diagnostics on the market. It includes also therascreen KRAS for CRC, therascreen EGFR for non-small cell lung cancer (NSCLC), 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’s Day-One readiness program

Cancer drugs submitted to the FDA for approval are ideally already paired with companion diagnostics during their clinical trials. A companion diagnostic test that is approved and available as soon as the therapeutic drug is released to the market allows patients to benefit immediately from the targeted therapy. This timing is crucial, as some cancer patients may not have time to wait for labs to validate a new test.

To close this gap, QIAGEN has developed a dedicated Day-One readiness program to ensure that the companion diagnostic is available on the day the drug is approved. The program enables diagnostic labs to implement the activities necessary to prepare new companion diagnostic testing services for commercial launch before FDA approval is granted.


QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2022, QIAGEN employed more than 6,200 people in over 35 locations worldwide. Further information can be found at

About Mirati Therapeutics, Inc.

Mirati Therapeutics, Inc. is a biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

i Lung cancer statistics. WCRF International. Published April 14, 2022.

ii Arbour, K.C., et al. (2018). Effects of Co-occurring Genomic Alterations on Outcomes in Patients with KRAS-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 24(2): 334-340.

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