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

HILDEN, Germany GERMANTOWN, Maryland FORT MYERS, Florida–(BUSINESS WIRE)–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/