Search form

Invader MTHFR 677 Assay

As part of the Hologic Invader suite of assays, Invader MTHFR 677 is an in vitro diagnostic test that simply and accurately screens for one of the four most relevant mutations associated with thrombophilia: methylenetetrahydrofolate reductase (MTHFR) 677.1-5

These innovative Invader assays detect and genotype single-point mutations in isolated genomic DNA obtained from whole blood samples.


Based on our Invader Plus chemistry, the Invader assays involve PCR-based target amplification followed by signal generation. Signal generation is composed of primary and secondary reactions:

  • Primary reaction — specifically and accurately detects the presence or absence of a particular target sequence.
  • Secondary reaction — used for signal amplification and result readout.

All necessary probes and oligonucleotides needed for target amplification and signal generation are included in the Invader assay kit.


Adopting the Invader thrombophilia assays into your molecular testing offerings promises the following simple, cost-effective and reliable features:

Exceptional ease of use

  • Common reaction conditions promote technologist proficiency.

Simplified analysis

  • Dedicated software provided for quick and accurate data analysis.

Cost-effective to adopt

  • Uses standard laboratory equipment and instrumentation, such as thermal cyclers and fluorescence plate readers.

Confidence of reliable assays6

  • Accurate — 99.45% or greater compared to bi-directional DNA sequencing.
  • Reproducible — 99.5% or greater between different users and sites.
  • Consistent — 100% lot-to-lot agreement.

The Invader MTHFR 677 test is FDA-cleared for in vitro diagnostic use in the U.S., May 13, 2011.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

  1. Factor V Leiden Ridker PM, Miletich JP, Hennekens CH, Buring JE (1997). “Ethnic distribution of factor V Leiden in 4047 men and women. Implications for venous thromboembolism screening.” JAMA 277 (16): 1305–7.
  2. Gregg JP, Yamane AJ, Grody WW (December 1997). “Prevalence of the factor V-Leiden mutation in four distinct American ethnic populations.” American Journal of Medical Genetics 73 (3): 334–6.
  3. De Stefano V, Chiusolo P, Paciaroni K, Leone G (1998). “Epidemiology of factor V Leiden: clinical implications.” Seminars in Thrombosis and Hemostasis 24 (4): 367–79.
  4. Factor II (Prothrombin) Martinelli I, Bucciarelli P, Mannucci PM (2010). “Thrombotic risk factors: basic pathophysiology.” Crit Care Med 38 (2 Suppl): S3–9.
  5. MTHFR Varga EA, Sturm AC, Misita CP, Moll S. Homocysteine and MTHFR Mutations: Relation to Thrombosis and Coronary Artery Disease. Circulation. 2005; 111: e289-e293.
  6. Product inserts, Invader Factor V #15-3217, Rev 100, Invader Factor II #15-3216, Rev100, Invader MTHFR 677, #15-3218, Rev 100 & Invader MTHFR 1298, #15-3219, Rev 100.