Sequenom Files Premarket 510(k) Notification With FDA For IMPACT Dx™ System Company Receives ISO 13485 Certification
SAN DIEGO, Oct. 2, 2013 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that it has submitted Premarket 510(k) Notifications to the United States Food and Drug Administration (FDA) for its IMPACT Dx™ System and its IMPACT Dx™ Factor V Leiden and Factor II Genotyping Test. The system and test are intended for use in the clinical laboratory setting.
"The submission of our premarket notifications is a tremendous achievement that we believe contributes significant value to our Genetic Analysis business segment and represents the transition of our proven research-use-only MassARRAY® System into the clinical diagnostics arena," said Michael Monko, Senior Vice President, Genetic Analysis at Sequenom, Inc.
In anticipation of applying the CE mark for the IMPACT Dx System, the Company also received ISO 13485:2003 and EN ISO 13485:2012 certification for its quality management system. The ISO 13485 certification confirms that the Company's medical device manufacturing quality management system is compliant with globally recognized standards set forth by the International Organization for Standardization (ISO). The Company is finalizing plans to commercialize the IMPACT Dx System in a number of European countries that require CE marking.
"The receipt of ISO 13485 certification further validates our commitment to implementing and executing only the highest quality standards in all areas of our business," said Bill Welch, President and COO of Sequenom, Inc. "With this certification, we now have the ability to continue executing on our strategy for expanding and deepening the breadth of our diagnostic tests and services globally."
The IMPACT Dx System is intended for the detection of multiple analytes in a DNA sample utilizing matrix-assisted desorption ionization time-of-flight (MALDI-TOF) mass spectrometry. The IMPACT Dx System is designed for use with Sequenom-developed genotyping tests, such as the IMPACT Dx Factor V Leiden and Factor II Genotyping Test, which is intended as an aid in the diagnosis of patients with suspected thrombophilia. Additional tests will be added over time. For additional information, visit www.sequenom.com.
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
SEQUENOM®, MassARRAY® and IMPACT Dx™ are trademarks of Sequenom, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the contribution and impact of the Premarket 510(k) Notifications on the Company's Genetic Analysis business segment, the transition of the MassARRAY System into the clinical diagnostics arena, the Company's anticipation of obtaining and applying a CE mark on the IMPACT Dx System, the Company's plans to commercialize the IMPACT Dx System in a number of European countries, the Company's ability to continue executing on its strategy for expanding and deepening the breadth of diagnostic tests and services globally, and Sequenom's commitment to improving healthcare through revolutionary 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 market demand for and acceptance and use of technology and products such as the IMPACT Dx System and IMPACT Dx Genotyping Tests, reliance upon the collaborative efforts of other parties such as, without limitation, healthcare providers, international distributors and licensees, the Company or third parties obtaining or maintaining regulatory approvals that impact the Company's business, government regulation particularly with respect to diagnostic products and laboratory developed tests, publication processes, the performance of designed product enhancements, the Company's ability to develop and commercialize technologies and products, particularly new technologies such as diagnostics, laboratory developed tests, and genetic analysis platforms, the Company's financial position, the Company's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, litigation involving the Company, and other risks detailed from time to time in the Company's most recently filed Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, its most recently filed reports on Form 8-K, and its most recently filed Annual Report on Form 10-K, 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.
SOURCE Sequenom, Inc.