US-based Agena Bioscience has received US Food and Drug Administration (FDA) premarket clearance for the IMPACT Dx Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx System.
Agena said that IMPACT Dx combined function system will also be available in the European Union (EU).
The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is carried out on the system and is indicated for use as an aid in diagnosing patients with suspected thrombophilia. The test is intended for in vitro diagnostic use in a clinical laboratory setting.
Factor V Leiden mutation increases risk of venous thromboembolism seven-fold to 80-fold.
The company said that individuals heterozygous for the Factor II prothrombin mutation have 25% higher plasma prothrombin levels than individuals with wild type genotype, and a 2.8-fold increased risk of venous thromboembolism.
Agena Bioscience chairman and interim CEO John Lillig said: "The clearance of our IMPACT Dx Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx System is a tremendous achievement that we believe contributes significant value to our business and represents the transition of our proven research-use-only MassARRAY System into the clinical diagnostics arena."
The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is carried out using the IMPACT Dx System, which uses matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry to interrogate nucleic acids.
The IMPACT Dx System is designed for use with FDA-cleared or approved tests citing its use.