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 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.
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 pharmaceutical 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. 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 products to customers inemia, 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); ability to obtain regulatory approval of 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 products from competitors' products; market acceptance of the company's products; market acceptance and integration of the company.