• QIAGEN to develop PCR test to detect isocitrate dehydrogenase-1 (IDH1) mutations in AML patients to be used with Servier’s marketed and investigational targeted treatment

• Test for blood and bone marrow samples to run on QIAGEN Rotor-Gene Q device

• QIAGEN now working with more than 30 companies to develop and commercialize companion diagnostics

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a strategic partnership with Servier, a global pharmaceutical group, to develop a companion diagnostic test for TIBSOVO^®, an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of the blood cancer acute myeloid leukemia (AML).

Under the Master Collaboration Agreement, QIAGEN will develop and validate a real-time in vitro PCR test that can be used to detect IDH1 gene mutations in AML patients in whole blood and bone marrow aspirates.

The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide. QIAGEN’s experienced regulatory teams will support clinical validation of the companion diagnostic and its approval in the US, the European Union and Japan.

“Patients with AML may deteriorate rapidly if not treated quickly so we are pleased to support Servier with a companion diagnostic in their mission to propose innovative treatment for IDH1 mutated AML patients,” said Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics, at QIAGEN. “At the same time, we are further strengthening our role in developing companion diagnostics for the ever-growing number of biomarkers being discovered in onco-hematology.”

Brian Lockhart, Global Head of Companion Diagnostics at Servier, said: “In order to expand the global access for TIBSOVO^® for patients, it is imperative that we leverage a partner such as QIAGEN with an established global footprint in oncology-driven diagnostics, and a proven expertise in companion diagnostics development and approvals.”

AML is a hard-to-treat cancer of the blood and bone marrow. IDH1 mutations are present in about 6 to 10 percent of cases¹. One of the most common types of leukemia in adults, the disease often occurs in patients in their late 60s or older.

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. QIAGEN currently has eleven PCR-based companion-diagnostics tests that have been approved by the US Food and Drug Administration (FDA). Furthermore, the company announced collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

About QIAGEN

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 http://www.qiagen.com.

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).

Source: QIAGEN N.V.

Category: Corporate

¹ American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html.

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