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Sequenom, Inc.. (6/16/14). "Press Release: Sequenom, Inc. Receives U.S. FDA Premarket Clearance". San Diego, CA.

Region Region United States (USA)
Organisations Organisation Sequenom Inc. (Nasdaq: SQNM)
  Group LabCorp (Group)
  Organisation 2 Agena Bioscience Inc.
  Group Agena Bioscience (Group)
Products Product ImpactDx™ system
  Product 2 ImpactDx™ Factor V Leiden and Factor II Genotyping Test
Index term Index term Agena Bioscience–Sequenom: MassArray technology, 201405 acquisition $31.8m + $4m milestones of Sequenom bioscience business by Agena
Persons Person Welch, William J. (Bill) (Sequenom 201101– SVP Diagnostics before Monogram 200803– before Dade Behring before La Jolla)
  Person 2 Lillig, John (IRORI Technologies 201311– CEO before Brooks Life Science Systems + Nexus Biosystems)
     


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.

   
Record changed: 2016-03-20

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