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Home / Tests / Oncology/Genetics / Xpert FII & FV

Xpert® FII & FV

30-minute Test for Genetic Risk of Thrombosis

Xpert<sup>®</sup>&nbsp;FII &amp; FV

The Need

Thrombophilia is defined as an increased risk or tendency to develop blood clots (thrombi) in veins, arteries or both. Venous thrombophilia may result in deep venous thrombosis (DVT) or pulmonary embolism (PE) and is the result of either inherited or acquired defects (or an interaction between the 2) in the coagulation system. The most commonly associated genetic mutations for inherited thrombophilia are mutations in the genes for Factor V Leiden and Factor II (prothrombin).1

Genetic risk factors predispose to thrombophilia and play the most important etiopathogenic role in venous thromboembolism (VTE) in people younger than 50 years old. At least one inherited risk factor could be found in about half of the cases with a first episode of idiopathic VTE.2

There is a high incidence of venous thrombo-embolism (VTE) in hospitalized patients and they are a major cause of sudden death in this patient population. VTE recurs frequently; about 30% of patients develop recurrence within the next 10 years and 10% to 30% of people die within one month of diagnosis.3

The Solution

Xpert® FII & FV is a qualitative genotyping test for the fast detection of Factor II and Factor V alleles. Performed on the Cepheid GeneXpert System, the test is intended to provide rapid results for Factor II mutation c.*97G>A (formally 20210G>A) and Factor V Leiden c.1601G>A (R506Q) mutations as an aid in the diagnosis of suspected thrombophilia.


  • Molecular lab in a cartridge — DNA Extraction, amplification, detection and controls in one cartridge
  • 24/7 availability — Run daily, or on-demand, with a simplified workflow

Clinically Validated

  • Proven accuracy — Multi-site study verified over 1,000 patient samples with results comparable to those obtained with bi-directional sequencing4

Fast Actionable Results

  • Detection of FII c.*97G>A, Factor V Leiden in 30 minutes

Cepheid’s Xpert FII & FV test provides on-demand results you can trust and empowers your clinical team to better manage patients.

The Impact

Actionable: Avoid costly ‘send out’ testing, and associated wait for results. Improve patient management with fast test answers on-demand.

Optimized: Cartridge-based testing system, for either or both mutations, removing the risk of non-optimal reagent use associated with batch testing.

Efficient: No requirement for specialized lab personnel or facilities. Just add blood sample to the cartridge and get results in 30 minutes. 

Shift your lab from reactive to proactive with same-day results for clinicians.

1. Mannucci P.M et al. Classic thrombophilic gene variants. Thromb Haemost. 2015 Nov;114(5):885-9.
2. Hotoleanu C. Genetic Risk Factors in Venous Thromboembolism. Adv Exp Med Biol. 2017;906:253-272.
3. Heit J et al. The epidemiology of venous thromboembolism. J Throm Thrombolysis 2016 41: 3-14 CDC. Accessed Aug 2020
4. Xpert® Factor II & Factor V Kit Package Insert. Sunnyvale. USA 2017.

Ordering Info

Xpert® FII & FV

Number of Tests: 10 

Catalog #: GXFIIFV-10
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