QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications

• Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers

• QIAGEN to make kit-based HRD test available globally to support research and companion diagnostics development in collaboration with pharmaceutical partners enabling wider adoption and potential clinical indication expansion for MyChoice CDx

• Project builds on recently announced master collaboration agreement between the two companies

VENLO, The Netherlands and SALT LAKE CITY, May 30, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

The test will be based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, which creates a sample to insight HRD solutions, and Myriad’s proprietary FDA-approved MyChoice CDx, a single-site PMA-approved centralized testing service for analyzing HRD in certain tumors. MyChoice CDx assesses the HRD status by examining a tumor’s DNA repair capabilities, particularly focusing on BRCA1 and BRCA2 gene mutations and calculating a Genome Instability Score (GIS). The GIS aids in pinpointing ovarian cancer patients who are most likely to benefit from targeted treatments, such as LYNPARZA® (olaparib) by AstraZeneca.

“Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics. Together, we aim to broaden the accessibility of HRD tests, allowing an increasing number of cancer patients to benefit from tailored treatments,” said Fernando Beils, Senior Vice President and head of the Molecular Diagnostics Business Area. “By introducing a distributable HRD test, we anticipate a reduction in the time required for therapy decisions, a decrease in associated costs, and shorter turnaround times compared to outsourced testing, ultimately benefitting the patients.”

The MyChoice CDx assay can identify 34% more tumors with HRD using the GIS score compared to other methods only using percent loss of heterozygosity (%LOH)¹. Given that approximately 48% of ovarian cancer tumors exhibit HRD², often due to specific mutations within the tumor, expanding access to this assay is vital for advancing personalized medicine and ensuring that patients receive the most appropriate treatments.

“We’re excited to share this milestone in our partnership with QIAGEN as we work collectively to advance cancer care worldwide,” said Patrick Burke, Executive Vice President of Strategy and Innovation, Myriad Genetics. “By extending the global reach and ease of access to Myriad’s gold-standard HRD-testing technology we aim to help drive wide-spread and broader clinical adoption of HRD testing. This milestone demonstrates what the QIAGEN and Myriad partnership is uniquely able to deliver to pharmaceutical partners – propriety content, cutting edge assay platforms, clinical trial execution, and world-wide CDx product distribution.”

QIAGEN will manage the development and distribution of the kit-based HRD test outside of the United States. The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States. The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN’s QIAseq panels enable efficient and accurate NGS library preparation. Over 4 million samples have been processed with QIAseq panels for cancer testing applications.³

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies – a deep pipeline that helps advance precision medicine in diverse disease indications, tailoring a patient’s treatment to the genetic profile identified by companion diagnostics testing. Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad’s oncology products portfolio.

About Myriad Genetics

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2024, QIAGEN employed approximately 5,900 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, including statements relating to the development of a globally distributable kit-based test for analyzing HRD status and the anticipated benefits of the Myriad and QIAGEN partnership, including that the partnership may drive the expansion of Myriad’s oncology products portfolio and enable potential clinical indication expansion for MyChoice CDx. To the extent that any of the statements contained herein relating to QIAGEN’s products, 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, 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.

Any “forward-looking statements” relating to Myriad or the development of a globally distributable kit-based test for analyzing HRD status are Myriad’s management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in Myriad’s filings with the U.S. Securities and Exchange Commission, including Myriad’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time Myriad’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

Contacts QIAGEN:

¹ Timms, et al. JClinOnc 2020 38:15_suppl, 1586-1586.
² Moore et. al, Lancet Oncol 2019
³ QIAseq products are intended for molecular biology applications. These products are not intended for the diagnosis, prevention, or treatment of a disease.