QIAGEN and Myriad Genetics partner to advance companion diagnostics development for cancer

• Partnership covers development of lab-developed and distributable kit-based companion diagnostic tests
• Combined strengths in assay development, clinical testing, and regulatory approvals offers pharma partners comprehensive global companion diagnostic solutions based on PCR, digital PCR (using the QIAcuity system), and NGS
  
• Future projects may include advanced analysis and accessibility of measurable residual disease (MRD) and homologous recombination deficiency (HRD) assays to potentially improve cancer treatment decision-making
  

VENLO, The Netherlands, and SALT LAKE CITY, Oct. 26, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced a new master collaboration agreement to develop companion diagnostic tests in the field of cancer.

The partnership aims to deliver innovative services and products to pharmaceutical companies, enabling the development and commercialization of proprietary cancer tests for the U.S. clinical market, and providing distributable companion diagnostic test kits for the global market.

The alliance between QIAGEN and Myriad brings together the respective strengths of each partner. Myriad leverages its CLIA-certified, CAP-accredited lab platform, assay development expertise and robust commercial infrastructure for clinical sample testing. QIAGEN will provide Sample to Insight solutions, including sample preparation, its PCR, digital PCR (using the QIAcuity system), QIAseq next-generation sequencing (NGS) technologies, instruments, as well as the QIAGEN Digital Insights portfolio of bioinformatics. Additionally, QIAGEN contributes GMP-certified product manufacturing capabilities and globally established commercial channels. The partnership also capitalizes on the combined FDA and worldwide regulatory expertise of both companies, providing seamless compliance and integration in clinical and companion diagnostic applications.

“We are pleased to collaborate with Myriad, combining their expertise in complex and proprietary lab-developed tests with our proficiency in distributable kit-based solutions, to offer a comprehensive global companion diagnostic approach. Our partnership aims to accelerate the advancement of cancer companion diagnostics, making them accessible to pharma partners worldwide,” said Jonathan Arnold, Vice President, Head of Translational Science and Precision Diagnostics at QIAGEN. “Together, we share the common goal of improving patient care and guiding treatment decisions in oncology through our combined expertise and capabilities.”

“Our partnership with QIAGEN creates a comprehensive companion diagnostic development and commercialization solution for our pharma partners that will support the advancement of cancer care and personalized treatment decisions for patients worldwide,” said Paul Bartel, Senior Vice President of Companion Diagnostics, Myriad Genetics. “As we grow Myriad’s presence globally in the companion diagnostics space, we are excited to partner with QIAGEN to increase access to these solutions, and help more patients and providers make effective therapeutic choices.”

The initial project focus for the two companies will involve collaborating with pharma partners to develop assays utilizing next-generation sequencing workflows or QIAGEN’s digital PCR platform, QIAcuity.

Future projects are under consideration to explore advancing and kitting next-generation detection of measurable residual disease (MRD), which involves using circulating tumor DNA (ctDNA) assays to detect cancer that may remain in a patient’s body following treatment, and homologous recombination deficiency (HRD), a condition where cells are unable to repair damaged DNA effectively, potentially increasing the survival ability for cancers treated with chemotherapy.

MRD is a highly complex workflow, and both companies plan to collaborate in assessing the feasibility of integrating digital PCR to produce a kitted and standardized solution for diagnostic laboratories.

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies – a deep pipeline that will advance precision medicines 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 portfolio of oncology products.

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 June 30, 2023, QIAGEN employed more than 6,100 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 constitute 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 QIAGEN’s and Myriad’s partnership to develop companion diagnostic tests and solutions, expected future projects, and the anticipated benefits of the companies’ partnership. 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.

Any “forward-looking statements” relating to Myriad 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 March 1, 2023, 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:

Contacts Myriad: