QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications
QIAGEN and Myriad Genetics have announced a collaboration to develop a kit-based test for Homologous Recombination Deficiency (HRD). This next-generation sequencing (NGS) test leverages QIAGEN’s QIAseq xHYB technology and Myriad’s FDA-approved MyChoice CDx biomarkers.
The test will support research and companion diagnostics development, aiding personalized medicine for ovarian and other solid tumors. The goal is to enhance decentralized testing, reduce therapy decision times, and lower associated costs.
The MyChoice CDx assay can identify 34% more HRD tumors compared to other methods. This initiative builds on a recently announced collaboration agreement and aims to expand the accessibility and clinical adoption of HRD testing globally.
- Collaboration between QIAGEN and Myriad Genetics aims to develop a globally distributable HRD test.
- The new test leverages QIAGEN’s QIAseq xHYB technology and Myriad’s FDA-approved MyChoice CDx biomarkers.
- The test supports research and development in personalized medicine for various solid tumors.
- Enhances decentralized testing, shortens therapy decision times, and lowers associated costs.
- The MyChoice CDx assay can identify 34% more HRD tumors compared to other methods.
- QIAGEN has processed over 4 million samples with QIAseq panels for cancer testing applications.
- QIAGEN has collaboration agreements with over 30 global pharma and biotech companies.
- Myriad Genetics has supported hundreds of clinical trials and obtained 10 companion diagnostic approvals from FDA and PMDA.
- The project may face regulatory challenges outside the United States.
- There could be unforeseen delays in the development and distribution of the HRD test.
- Potential high development costs associated with creating the new HRD test.
- Risk of competition from other companies developing similar HRD testing technologies.
Insights
The collaboration between QIAGEN and Myriad Genetics to develop a globally distributable HRD test is a significant step in expanding personalized cancer treatment options. One of the key advantages of this next-generation sequencing (NGS)-based test is that it leverages Myriad's well-established MyChoice CDx biomarkers, which are FDA-approved and renowned for their efficacy in identifying HRD statuses in ovarian cancer tumors.
For medical research, the ability to globally distribute a reliable and robust HRD test can potentially accelerate research into various solid tumors, not just ovarian cancer. This enables more precise and personalized treatment plans, thus improving patient outcomes. The focus on HRD, particularly mutations in BRCA1 and BRCA2 genes, allows for targeted therapies like LYNPARZA® (olaparib) to be more effectively utilized. The combination of QIAGEN’s QIAseq xHYB technology and Myriad's Digital Insight solutions is expected to enhance accuracy and turnaround times, which is important in clinical applications.
Furthermore, the decentralized nature of the proposed kit-based test means that it could significantly reduce the delay between diagnosis and treatment initiation, which is a critical factor in cancer therapy. The collaborative efforts also promise to lower costs associated with outsourced testing, thus making advanced diagnostics more accessible to a broader patient population. The potential for widespread adoption is also high due to the combined regulatory expertise of both firms, allowing seamless integration in various clinical settings.
From a financial perspective, the collaboration presents substantial growth opportunities for both QIAGEN and Myriad Genetics. The ability to distribute a globally recognized HRD test can open new revenue streams and expand their market reach. QIAGEN’s involvement in managing the development and distribution of this test outside the U.S. underlines their strategic move to strengthen their presence in the international market, supported by their existing relationships with over 30 global pharma and biotech companies.
The project is expected to benefit from QIAGEN's established infrastructure for NGS library preparation, reinforced by over 4 million processed samples with QIAseq panels in cancer testing applications. This gives QIAGEN a robust platform to ensure consistency and reliability in test results – a critical factor for adoption by pharmaceutical partners and clinical settings. Similarly, Myriad’s extensive experience in clinical trial support and their ten FDA and PMDA-approved companion diagnostics signify a credible and strong partnership foundation.
In the short term, the announcement could positively influence investor sentiment, given the potential for widened adoption and increased sales of the new kit-based HRD test. Long-term benefits include sustained revenue growth through global market penetration and increased adoption of personalized medicine approaches in oncology, potentially driving higher margins and reinforcing both companies' positions in the precision medicine market.
For oncologists, the development of a distributable HRD test is a promising advancement in the clinical landscape. The use of MyChoice CDx biomarkers to determine a tumor’s HRD status by examining DNA repair capabilities and calculating the Genome Instability Score (GIS) provides a more comprehensive approach to identifying patients who can benefit from targeted therapies like olaparib. This is particularly valuable for ovarian cancer, where approximately 48% of tumors exhibit HRD.
Moreover, the HRD test’s ability to identify 34% more tumors with HRD compared to tests that only use the percentage loss of heterozygosity (%LOH) highlights its improved accuracy and potential for better patient stratification. This means more patients could be identified for effective treatment regimens, improving overall treatment efficacy and patient outcomes.
The anticipated reduction in therapy decision time and cost savings, due to decentralized and faster testing, would also positively impact clinical practice. Shorter turnaround times can lead to quicker treatment initiation, which is often critical for oncology patients. The collaboration therefore promises to enhance the speed and precision of cancer diagnostics and treatment, advancing the standard of care in oncology.
Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digitial 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, Utah, 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
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.
Source: QIAGEN N.V.
Category: Corporate
[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.
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