On November 30, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeoGenomics, Inc. (NASDAQ: NEO) reported a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients (Press release, Qiagen, NOV 30, 2018, View Source [SID1234531758]). 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.

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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) (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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 View Source