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Sequenom Files for FDA Clearance of Impact Dx System, Thrombophilia Test

NEW YORK (GenomeWeb News) – Sequenom said after the close of the market on Wednesday that it has filed for marketing clearance from the US Food and Drug Administration of its Impact Dx System and Impact Dx Factor V Leiden and Factor II Genotyping Test.

The system and test are intended for use in clinical laboratories.

The Impact Dx System is used for detecting multiple analytes in DNA samples using matrix-assisted desorption ionization time-of-flight mass spectrometry. It is designed to be used with Sequenom's genotyping tests, including the Impact Dx Factor V Leiden and Factor II Genotyping Test, an aid for diagnosing patients with suspected thrombophilia.

Additional tests will be developed, the company said.

"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," Michael Monko, senior vice president, genetic analysis at Sequenom, said in a statement.

Submission of the system and test for FDA 510(k) clearance follows the authorization of a strategic review of the Genetic Analysis business by Sequenom's board last week.

Sequenom further said that it anticipates applying for the CE mark for the Impact Dx System and has received ISO 13485:2003 and EN ISO 13485:2012 certification for its quality management system. ISO 13485certification confirms that Sequenom's medical device manufacturing quality management system complies with globally recognized standards created by the International Organization for Standardization, it said.

Sequenom is finalizing plans to launch the Impact Dx System in certain European countries that require CE marking.

"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," Sequenom President and COO Bill Welch said.