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