Sequenom, Inc. Receives U.S. FDA Premarket Clearance
SAN DIEGO, June 16, 2014
SAN DIEGO, June 16, 2014 /PRNewswire/ --Sequenom, Inc. (NASDAQ: SQNM), a life
sciences company providing innovative genetic analysis solutions, announced
today that it has received premarket 510(k) clearance from the United States
Food and Drug Administration (FDA) to market its IMPACT Dx™ Factor V Leiden
and Factor II Genotyping Test and the IMPACT Dx™ System. The IMPACT Dx Factor
V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System,
and is indicated for use as an aid in the diagnosis of patients with suspected
As previously announced, Sequenom completed the sale of its Bioscience
business segment to Agena Bioscience. As part of this sale, the Premarket
510(k) Notification will transfer to Agena Bioscience and Sequenom will
receive $2 million upon the achievement of this regulatory milestone.
"The FDA clearance is a tremendous achievement for Sequenom and demonstrates
our ability to successfully navigate the FDA regulatory process," said William
Welch, Chief Executive Officer, Sequenom, Inc.
"The MassARRAY System has become a fundamental tool for genomic research.
With the FDA clearance of the IMPACT Dx test system, we are now poised to
enter the clinical diagnostic arena," said John Lillig, Chairman and Interim
Chief Executive Officer, Agena Bioscience.
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to
improving healthcare through revolutionary genomic and genetic analysis
solutions. Sequenom develops innovative technology, products and diagnostic
tests that target and serve discovery and clinical research, and molecular
diagnostic markets. Website: www.sequenom.com.
About Agena Bioscience
Agena Bioscience is a San Diego, CA based life science and clinical diagnostic
company that offers the MassARRAY System. The system is a highly sensitive,
quantitative method for nucleic acid detection via MALDI-TOF mass spectrometry
for high-throughput genotyping and mutation profiling for cancer and other
disease research, companion diagnostics, pharmacogenomics, epigenetics,
clinical genetics, ag-bio genetics, and biobanking molecular sample
identification. Website: www.agenabioscience.com.
SEQUENOM® is a registered trademark of Sequenom, Inc. All other trademarks
and service marks are the property of their respective owners.
Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Sequenom's transfer of
the Premarket 510(k) Notification to Agena Bioscience and Sequenom's receipt
of payment upon the achievement of that milestone, and Sequenom's commitment
to improving healthcare through revolutionary genomic and genetic analysis
solutions, are forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties that
may cause actual results to differ materially, including the risks and
uncertainties associated with reliance upon other parties such as Agena
Bioscience, and other risks detailed from time to time in the Company's most
recently filed Quarterly Report on Form 10-Q, its most recently filed reports
on Form 8-K, and its most recently filed Annual Report on Form 10-K/A, and
other documents subsequently filed with or furnished to the Securities and
Exchange Commission. These forward-looking statements are based on current
information that may change and you are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of this
press release. All forward-looking statements are qualified in their entirety
by this cautionary statement, and the Company undertakes no obligation to
revise or update any forward-looking statement to reflect events or
circumstances after the issuance of this press release.
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SOURCE Sequenom, Inc.
Contact: Sequenom Contacts: Carolyn Beaver, Chief Financial Officer, Sequenom,
Inc., 858-202-9028, email@example.com; Rachel Kennedy, Media
Contact, Chandler Chicco Agency, 858-449-9575,
firstname.lastname@example.org; Agena Bioscience Contact: Fritz Eibel,
Head of Commercial Operations, Agena Bioscience, 858-242-1720,
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