Designed for use with the company’s IMPACT Dx Factor V Leiden and Factor II genotyping test and other genotyping tests, the IMPACT Dx system detects multiple analytes in a DNA sample using matrix-assisted desorption ionization time-of-flight mass spectrometry.
The IMPACT Dx Factor V Leiden and Factor II genotyping test is intended as an aid in the diagnosis of patients with suspected thrombophilia.
The company also obtained ISO 13485:2003 and EN ISO 13485:2012 certification, confirming that its medical device manufacturing quality management system is compliant with the International Organization for Standardization (ISO) standards.
Sequenom genetic analysis senior vice president Michael Monko 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."
The company anticipates applying the CE Mark for the IMPACT Dx system and it is also finalizing its plan to commercialize the system in a number of European countries.
