Boston, MA 10/18/2013 (wallstreetpr) – Sequenom, Inc. (NASDAQ:SQNM) an innovator in the clinical research and clinical molecular diagnostic instrumentation, technology and tests has notified two of its latest products: “IMPACT Dx™ System and its IMPACT Dx™ Factor V Leiden and Factor II Genotyping Test” with FDA, in early October. Both the system and the test are for high value clinical laboratories.
Michael Monko, Senior Vice President, Genetic Analysis at Sequenom, Inc. commented that, ‘the submission of our premarket notifications is a tremendous achievement that we believe contributes significant value to our Genetic Analysis business segment.’ SQNM believes that these two new test systems showcase,” the change of the company from the older MassARRAY® System, which was purely research-use-only to the more advanced and high performing clinical diagnostics domain.”
As of September end, the company has already announced new investment options for November 16 Expiration.
According to SQNM press release, it has successfully completed various compliance requirements, such as ‘ISO 13485:2003 and EN ISO 13485:2012’ in anticipation of is CE mark. As per ISO 13485 certification, it qualifies the company for ‘manufacturing medical equipment as per required International Organization for Standardization (ISO).’ The company has already finalized plans to make IMPACT Dx system more commercialized. Additionally, this will allow the company to access European countries where CE marking is important for genotype testing.
IMPACT DX system will be used in the process for detecting multiple risks through DNA sampling and utilizing sophisticated testing methods. These genotyping tests and systems are expected to make the process of testing for thrombophilia more efficient. These tests will help in the diagnosis and detection of the diseases in patients suspected of carrying thrombophilia.
SQNM,is expected to increase the value of its testing and instrumentation systems by expanding its tests portfolio for this disease in the near future. As a life-science major the company has continually offered ‘healthcare revolutionary genetic analysis solutions.’
