QIAGEN and NeoGenomics collaborate to offer cancer patients Day-One access to innovative companion diagnostics for newly approved drugs

In Clinical Studies News by Barbara Jacoby

Source: QIAGEN

From: apnews.com

Nov 30, 2018–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeoGenomics, Inc. (NASDAQ: NEO) today announced a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients. The partnership between QIAGEN and NeoGenomics, a leading provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.

Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, especially next-generation sequencing (NGS) tests, the collaboration with NeoGenomics will allow QIAGEN and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions. The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.

QIAGEN and NeoGenomics will discuss their efforts to expedite access for precision medicine solutions at the American Society of Hematology (ASH) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego.

“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.

“We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics 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. “Together with our Pharma partners, we are now planning to provide investigational use only (IOU) tests to NeoGenomics and other labs, enabling them to verify, set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval. The companion diagnostic services can be promoted by NeoGenomics through their national commercial teams starting with their FDA approval, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients. We look forward to discussing this approach further at ASH 2018, and demonstrating our rapidly evolving Sample to Insight solutions to the world’s top hematology and oncology experts.”

NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus. The master service agreement provides a flexible framework with multiple options for co-development, verification, setup, and launch of new companion diagnostics, including next-generation sequencing tests, for biomarker profiling paired with new targeted drugs.

As QIAGEN collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic. Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for QIAGEN´s pharmaceutical partners. For more information, please visit https://www.qiagen.com/de/products/molecular-diagnostics/partnering-for-precision-diagnostics/.


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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed about 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services. The Company provides one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company’s Pharma Services division serves pharmaceutical clients in clinical trials and drug development. Headquartered in Fort Myers, Florida, NeoGenomics operates CLIA-certified laboratories in Aliso Viejo and Fresno, California; Tampa and Fort Myers, Florida; Houston, Texas; Nashville, Tennessee, and Rolle, Switzerland. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States. For additional information about NeoGenomics, visit http://neogenomics.com/