On June 12, 2014, the IMPACT Dx System by Agena Bioscience received 510(k) clearance from the FDA with the Factor V Leiden and Factor II Genotyping test. The IMPACT Dx System uses the same MALDI-TOF technology as our MassARRAY® System, with a simple user-friendly software interface designed for routine clinical use.

Clinical performance of the Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx System:

  • 97.9% sensitivity for Factor V Leiden
  • 98% sensitivity for Factor II
  • 100% specificity
  • 25 ng input DNA limit of detection
  • No cross-contamination