QIAGEN and Myriad Genetics 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. Meanwhile, 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, the companies say. 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.

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“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,” says Jonathan Arnold, VP, 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.”

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.

“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,” says Paul Bartel, senior VP 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.”

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. Meanwhile, 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.