Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test...
First received: April 10, 2013
Last updated: April 18, 2013
Last verified: April 2013
To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.
A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia
Study Start Date:
Estimated Study Completion Date:
What is Thrombophilia?
hrombophilias can be defined as a group of inherited or acquired disorders that increase a person’s risk of developing thrombosis (abnormal “blood clotting”) in the veins or arteries.
Interesting....Health Authority: United States: Food and Drug Administration not United States: Institutional Review Board
The factor V Leiden mutation is the most common genetic risk factor for venous thrombosis, a serious health problem affecting approximately 1 in 1000 people and leading to 50,000 deaths annually in this country. This mutation is involved in 20-40% of venous thrombosis cases and is present in 5% of the general population
Should be completed.
Also, notice the change in CHARMM - completion date now June 2015 (for 90 subjects, ? really?)and the language was rewritten in the protocol - look it up, interesting verbage substitutions?
In addition, a study published in JAMA, 2009;301:2472-2485 questions whether there is any clinical utility for factor V Leiden and Factor II testing at all.
This prompted AHRG (US Agency for Healthcare Research and Quality) to say that there is insufficient evidence that genetic testing for these mutations helps prevent DVT in patients or improves patient outcomes.
Do you have any idea how many companies already have FDA cleared factor V Leiden and Factor II tests on the market? And every one of those can be performed in the local hospital's lab instead of being shipped across the country, unlike the MassPLEX test.
And do you know what the current reimbursement rate is for Factor v Leiden and Factor II? only $50 each.