Boston, MA 06/17/2014 (wallstreetpr) – Sequenom, Inc. (NASDAQ:SQNM) on June 16, 2014 announced that the United States Food and Drug Administration (FDA) gave premarket 510(k) clearance to market the company’s IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx(TM) System.
What Is IMPACT Dx Factor V Leiden And Factor II Genotyping Test?
The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is being performed on IMPACT Dx System. It is being indicated to be used as the medical aid in diagnosing the patients suffering from suspected thrombophilia.
Market Clearance From FDA And Partnership Between Sequenom & Agena Bioscience
Sequenom, Inc. (NASDAQ:SQNM) had finished off the sale of Bioscience business segment of the company to Agena Bioscience and as per this sale transaction, the notification of Premarket 510(k) will be transferred to Agena Bioscience. Sequenom, in the meanwhile, will receive $2 million once the regulatory milestone is achieved.
Statement From The Chief Executive Officer Of Sequenom, Inc
The Chief Executive Officer of Sequenom, Inc. (NASDAQ:SQNM), William Welch said that the clearance from the FDA should be seen as a tremendous achievement for the company. He added that this go-ahead from FDA demonstrated the ability of the company to successfully navigate through the regulatory process of the Authority.
Statement From The Chairman And Interim Chief Executive Officer Of Agena Bioscience
The Chairman and Interim Chief Executive Officer, Agena Bioscience, John Lillig in this context said that the Mass ARRAY System is the fundamental tool for genomic research. The clearance from the FDA of IMPACT Dx Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx System made him poised to enter into the arena of clinical diagnostic and was a tremendous achievement which would add value to the business. He added that Agena Bioscience was looking forward to CE marking the IMPACT Dx Combined Function System in European Union sector.
