Boston, MA 06/17/2014 (wallstreetpr) – The life science company, Sequenom, Inc. (NASDAQ:SQNM) on June 16, 2014 declared that it has been given premarket 510(k) clearance from FDA (Food and Drug Administration of the U.S.).
FDA clearance:
The United States’ Food and Drug Administration has given Sequenom the premarket 510(k) clearance to market the IMPACT Dx Factor V Leiden, as well as Factor II Genotyping Test along with IMPACT Dx System. The Factor II Genotyping Test and IMPACT Dx Factor V Leiden is performed on the IMPACT Dx System, which is used as support in the diagnosis on patients suffering from thrombophilia.
The company previously announced that Sequenom completed its sale of the Bioscience business division to the San Diego based Agena Bioscience. As per the sale, the premarket 510(k) notification will be transferred to Agena and Sequenom will receive $2 million on achieving the regulatory target.
The CEO of Sequenom stated:
The Chief Executive Officer of Sequenom, William Welch, said that the clearance from FDA is a huge achievement for the company and demonstrates the ability to effectively navigate the FDA regulatory process.
The interim CEO of Agena says:
The interim Chief Executive Officer of Agena, John Lillig, commented that the MassARRAY System has turned into an elementary tool for genomic research. John added that with the clearance from FDA of IMPACT Dx test system, the company is now poised to get into the clinical diagnostic area.
Sequenom and Quest under an agreement:
On the very same day, Sequenom and Quest Diagnostics Inc (NYSE:DGX) announced an agreement according to which Quest will provide access to national laboratory-developed test (LDT) to Sequenom.
Licensed agreement with Quest:
Quest, the world’s leading diagnostic information service provider will offer the access to Sequenom from the third quarter of 2014. Besides this offer, Quest has also established a license contract for certain NIPT patents as well as patent applications with Sequenom. This is the first licensed agreement created by the Sequenom, Inc. (NASDAQ:SQNM) with any commercial laboratory in the U.S.
