HILDEN, Germany, GERMANTOWN, Md. & FORT MYERS, Fla.—QIAGEN and NeoGenomics have joined forces once again, exploring more ways that their respective specialties complement each other to provide mutually beneficial products and services to customers. Their latest master service agreement, announced in late 2018, paves the way for better access to precision medicine for cancer patients, with the companies saying their partnership will help ensure that patients and their oncologists will have immediate access to FDA-approved diagnostic tests in tandem with novel cancer drugs.
QIAGEN specializes in molecular diagnostics, creating assays that expedite the isolation, identification and processing of biomolecules. NeoGenomics is primarily focused on cancer-related genetic testing and comprehensive oncology-focused testing menus to aid physicians in diagnosing and treating cancer. Together, they will explore the potential of recent changes to the regulatory approach of the U.S. Food and Drug Administration (FDA) in the area of advanced diagnostics and next-generation sequencing (NGS) tests.
“We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics [CDx] during clinical trials and upon approval by the FDA, supporting synchronized launches of new oncology drugs, to make a difference for patients,” said Peer Schatz, CEO of QIAGEN when the deal was announced at the end of November. “Together with our pharma partners, we are now planning to provide investigational use only tests to NeoGenomics, enabling them to verify and set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval. The companion diagnostic services can be provided by NeoGenomics once FDA approval has been obtained, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients.”
Also, with the American Society of Hematology (ASH) annual meeting looming as he made the announcement and QIAGEN set to make presentations at ASH 2018, Schatz added: “We look forward to discussing this approach further ... and demonstrating our rapidly evolving ‘Sample to Insight’ solutions to the world’s top hematology and oncology experts.”
Development of a companion diagnostic alongside a novel therapeutic is challenging, but the FDA’s approval in 2017 of a complementary diagnostic has given companies license to explore how quickly a drug might be used in specific patients, note QIAGEN and NeoGenomics. This level of precision medicine means that doctors can readily identify patients who are more likely to benefit from therapy while reducing development time and expense.
The FDA took the first steps towards an improved regulatory process when they added new third-party reviewers in order to accelerate development of NGS-based tumor profiling. “We are modernizing the FDA’s approach to the efficient authorization of laboratory tests from developers that voluntarily seek 510(k) clearance,” said FDA Commissioner Dr. Scott Gottlieb in an FDA-issued press release. “This is another example of where the FDA is working to find creative and flexible approaches to regulation that spurs development and efficient delivery of innovative technology.”
According to Richard Watts, vice president of business development and companion diagnostic partnerships at QIAGEN, QIAGEN and NeoGenomics have taken notice and moved to mirror the FDA’s goal to accelerate development. “The full spectrum of a CDx, research through development, involves a CLIA lab as well as the ability to manufacture these tests globally in order for patients to access next-generation therapy from anywhere,” he said. “Our collaboration highlights this joint commitment. Now working seamlessly together at transition points along the CDx spectrum, our synergies mirror the FDA goals, creating a new framework that may speed the pace and reach of cutting- edge diagnostics while expanding the reach of patients globally.”
The master service agreement provides a flexible framework that will offer the partners a variety of options for co-development, verification, setup and launch of new companion diagnostics, as well as NGS-tests enabling biomarker profiling paired with new targeted drugs. Processes will be accelerated by QIAGEN offering systems and reagents up front for pharmaceutical research or assay development. Coupled with that, following FDA approval, NeoGenomics says it will have a CDx validated and ready to offer on day one, shortening the development work post-transfer to QIAGEN for manufacturing.
“As a leading provider of oncology testing for both clinical trials and patient care, NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests. Our collaboration with QIAGEN will ensure that patients have access to the most advanced companion diagnostics to target new cancer medicines, as soon as those medicines are approved. We are excited to work with QIAGEN to deploy cutting-edge technologies to remain at the forefront of precision medicine” said Douglas M. VanOort, chairman and CEO of NeoGenomics.