QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT® (avapritinib) in gastrointestinal stromal tumors
QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in U.S. to aid in identifying patients with unresectable or metastatic gastrointestinal stromal tumors positive for the PDGFRA D842V mutation who may be eligible for treatment with AYVAKIT® (avapritinib) // First FDA-approved companion diagnostic to detect mutation in the platelet-derived growth factor receptor alpha gene associated with primary resistance to other drugs // Approval adds to QIAGEN’s leading portfolio in precision medicine, including now 12 FDA approved companion diagnostics
Venlo, the Netherlands, and Germantown, Maryland, Aug. 07, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit).
This companion diagnostic is intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with AYVAKIT® (avapritinib), which is approved in the U.S. for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.
QIAGEN and Blueprint Medicines collaboratively developed the PDGFRA companion diagnostic assay. The real-time qualitative PCR in vitro diagnostic assay detects the D842V somatic mutation in the PDGFRA gene to determine which patients may be a candidate for treatment with AYVAKIT. The tyrosine kinase inhibitor (TKI) is designed to target the PDGFRA exon 18 D842V mutation and was approved by the FDA in 2020. GIST patients harboring the D842V mutation in PDGFRA exon 18 show primary resistance to previously approved TKIs.
The therascreen PDGFRA kit uses genomic DNA extracted from a patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for sample preparation and the Rotor-Gene Q (RGQ) MDx instrument for DNA amplification and mutation detection.
“The therascreen PDGFRA kit is an FDA approved and validated test, delivering results in a fast turnaround time. This ensures that physicians receive results promptly, enabling them to make informed treatment decisions for their GIST patients in a timely and effective manner,” said Jonathan Arnold, Vice President, Head of Translational Science and Precision Diagnostics at QIAGEN. “This latest approval confirms QIAGEN’s leadership in companion diagnostics development. It adds to QIAGEN’s extensive list of now 12 FDA-approved companion diagnostics.”
GIST is a rare, genomically driven sarcoma of the gastrointestinal tract. Approximately six percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations, the most common of which is the D842V mutation. Since the introduction of TKIs, including AYVAKIT, the treatment of GIST patients with locally advanced and metastatic disease has dramatically improved.
QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics. These can detect genetic abnormalities to provide insights that guide clinical decision-making about treatments. From polymerase chain reaction (PCR) and digital PCR (dPCR) to next-generation sequencing (NGS), QIAGEN offers an unmatched breadth of technologies, which means it can tailor products to partners’ needs.
QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global companies – a deep pipeline that will advance so-called precision medicine, which tailors a patient’s treatment to the genetic profile identified by companion diagnostics testing. Furthermore, QIAGEN has recently announced a series of collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.
AYVAKIT® is a registered trademark of Blueprint Medicines. Full prescribing information for AYVAKIT can be found here.
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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2023, QIAGEN employed more than 6,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.
Source: QIAGEN N.V
 AYVAKIT™ (avapritinib) Prescribing Information (U.S.). Blueprint Medicines Corporation, Cambridge, Massachusetts, USA
 Corless CL, Antonescu, C., Gastrointestinal stromal tumors: what do we know now? Modern Pathology: 2014. 27:1. https://doi.org/10.1038/modpathol.2013.173
 Blay, JY., Kang, YK., Nishida, T. et al., Gastrointestinal stromal tumours. Nat Rev Dis Primers 7, 22 (2021). https://doi.org/10.1038/s41572-021-00254-5
View source version on GlobeNewswire.com