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 thrombophilia.
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.
About Sequenom
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.
Forward-Looking Statements
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.