HILDEN, Germany, and SAN
CARLOS, Calif., March 12, 2018
/PRNewswire/ -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard:
QIA), a world leader in providing Sample to Insight molecular
solutions, and Natera, Inc. (NASDAQ: NTRA), a leading developer of
next-generation sequencing (NGS) assays that include non-invasive
prenatal genetic testing and the analysis of circulating tumor DNA,
today announced a partnership to develop cutting-edge, cell-free
DNA assays for use on QIAGEN's GeneReader NGS System.
These cell-free DNA assays will now be developed for use on the
GeneReader NGS System, the first fully integrated Sample to Insight
NGS solution, and designed to enable these type of tests, including
prenatal screening, for hospitals and laboratories globally.
Natera's Constellation™ software would also be accessible for users
of these and other assays in combination with the QIAGEN Clinical
Insights (QCI) bioinformatics solution.
"We are excited to partner with Natera, a global market leader
in non-invasive cell-free DNA genetic testing. Through this
strategic partnership, we are planning to offer assays that provide
significant clinical and economic value backed by extensive
validation data and large clinical studies. We intend to make these
assays available on the GeneReader NGS System to laboratories
around the world that are very eager to bring in-house genetic
testing across several applications, including prenatal screening,"
said Peer M. Schatz, Chief Executive
Officer of QIAGEN N.V. "The addition of these assays, along with
Natera's Constellation software, will substantially increase the
system's value and utility for a broader range of customers beyond
the current menu focused on oncology."
"This strategic partnership is an important milestone in the
development of Natera, and we welcome the opportunity to partner
with QIAGEN since both companies share a commitment to providing
customers with actionable and often life-changing clinical
insights," said Matthew Rabinowitz,
CEO of Natera. "We are combining Natera's molecular and clinical
experience in NGS content development with QIAGEN's expertise in
offering a complete and integrated NGS workflow to offer Sample to
Insight testing leveraging Natera's Constellation cloud platform.
We also believe the global reach of QIAGEN will help us capitalize
on the emergence and power of next-generation sequencing globally,
and make these assays broadly accessible to hospital systems and
laboratories worldwide."
The partnership builds on Natera's expertise in reproductive
genetics and non-invasive cell-free DNA testing. This includes
highly accurate and broad-coverage solutions for non-invasive
prenatal testing (NIPT) such as Panorama® and Vistara™, Horizon™
genetic-carrier testing, Spectrum® preimplantation genetic testing
(PGD/PGS), Anora® miscarriage testing, and recently the Signatera™
(RUO) high-sensitivity assay for use in oncology research.
The new NIPT assays will analyze maternal blood samples and
reflect the power of cell-free DNA to gain insights. Building on
QIAGEN's leading PAXgene blood cell-free DNA collection and sample
processing technology, which is fully automated and integrated into
the GeneReader NGS workflow, the tests are expected to selectively
differentiate fetal placental DNA from the background of the
mother's DNA to test whether a baby is at higher risk for common
genetic conditions. The Sample to Insight workflow will also
provide personalized risk reports for healthcare and genetic
counseling.
Financial summary
Under the 10-year agreement, QIAGEN
will pay Natera $40 million in
upfront licensing fees and prepaid royalties in the first quarter
of 2018. Natera is also eligible for an additional $10 million of milestone payments, as well as
ongoing royalty payments. Each company will bear its own
development costs for the assay. Natera and QIAGEN will establish a
complete Sample to Insight workflow with the GeneReader NGS System
and validate the sample preparation workflow using the
Constellation platform.
About the GeneReader system
The GeneReader NGS System
provides the first true Sample to Insight NGS workflow for
laboratories worldwide to take advantage of the power of NGS
technology. The system's integrated bioinformatics for analysis and
interpretation of NGS data, as well as a family of gene panels
under the GeneRead QIAact brand, enable laboratories to identify
gene variations linked to cancers and gain actionable molecular
insights. QIAGEN continues to add content for GeneReader, with a
pipeline of potential future tests in areas such as oncology,
prenatal testing, infectious disease genotyping, and customized
panels for specific needs. Integrated bioinformatics provide
streamlined, cloud-based analysis and interpretation. The current
version of the GeneReader NGS System is available in the United States for research use only (RUO).
For more information please visit www.genereaderngs.com.
About Natera
Natera is a global leader in cell-free
DNA testing. The mission of the company is to transform the
diagnosis and management of genetic disease. Natera operates an ISO
13485-certified and CAP-accredited laboratory certified under the
Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of
proprietary genetic testing services to inform physicians who care
for pregnant women, researchers in cancer including
biopharmaceutical companies, and genetic laboratories through its
cloud-based software platform. Follow Natera on LinkedIn and
Twitter.
All statements other than statements of historical facts
contained in this press release are forward-looking statements and
are not a representation that Natera's plans, estimates, or
expectations will be achieved. These forward-looking statements
represent Natera's expectations as of the date of this press
release, and Natera disclaims any obligation to update the
forward-looking statements. These forward-looking statements are
subject to known and unknown risks and uncertainties that may cause
actual results to differ materially, including with respect to our
or our partners' efforts to develop and commercialize new product
offerings, the success of our Constellation cloud-based
distribution model; our ability to successfully increase demand for
and grow revenues for our product offerings, whether the results of
clinical studies will support the use of our product offerings, our
expectations of the reliability, accuracy and performance of our
screening tests, the benefits of our screening tests and product
offerings to patients, providers and payers, or our expectations
regarding our strategic operations. Additional risks and
uncertainties are discussed in greater detail in "Risk Factors" in
Natera's recent filings on Forms 10-K and 10-Q and in other filings
Natera makes with the SEC from time to time. These documents are
available at www.natera.com/investors andwww.sec.gov
About QIAGEN
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
December 31, 2017, QIAGEN employed
approximately 4,700 people in over 35 locations worldwide. Further
information can be found at http://www.qiagen.com.
Certain statements contained in this press release may be
considered forward-looking statements within the meaning of Section
27A of the U.S. Securities Act of 1933, as amended, and Section 21E
of the U.S. Securities Exchange Act of 1934, as amended. To the
extent that any of the statements contained herein relating to
QIAGEN's products, 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 our products to customers in academia,
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); our
ability to obtain regulatory approval of our 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 our products
from competitors' products; market acceptance of QIAGEN's new
products and the integration of acquired technologies and
businesses. For further information, please refer to the
discussions in reports that QIAGEN has filed with, or furnished to,
the U.S. Securities and Exchange Commission (SEC).
Natera
contacts:
|
|
Investor
Relations
|
Media
|
Mike Brophy,
CFO
|
Anna Czene,
PR
|
650-249-9091 x
1471
|
818-731-2203
|
mbrophy@natera.com
|
aczene@natera.com
|
QIAGEN
contacts:
|
|
Investor
Relations
|
Public
Relations
|
John
Gilardi
|
Dr. Thomas
Theuringer
|
+49 2103 29
11711
|
+49 2103 29
11826
|
e-mail:
ir@QIAGEN.com
|
e-mail:
|
|
pr@QIAGEN.com
|
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SOURCE Natera, Inc.