Sequenom, Inc., 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.