The FDA approves the use of a plasma product to track FVIII activity

The FDA in the United States has approved CRYOcheck Factor VIII Deficient Plasma with VWF, a produced plasma product from Precision BioLogic, for use in laboratories. Utilizing blood samples, this product can be used to identify factor VIII (FVIII) insufficiency.

Normal blood coagulation requires the clotting factor FVIII. Due to an FVIII deficiency, hemophilia A patients are susceptible to severe bleeding. FVIII activity assays must be performed on a frequent basis by physicians in order to monitor FVIII levels and guarantee that patients are receiving the appropriate amount of replacement treatment.

These tests can make use of a standardized plasma product called CRYOcheck Factor VIII Deficient Plasma with VWF. It is created by depleting human plasma of FVIII and adding von Willebrand factor (VWF), another crucial clotting protein, to the mixture.

Recently, the FDA in the United States approved a novel plasma product for use in laboratories, which may enhance the precision and uniformity of FVIII activity tests. The product is a standardized plasma product known as CRYOcheck Factor VIII Deficient Plasma with VWF. It is made from human plasma that has had its FVIII levels reduced and is then enhanced with von Willebrand factor (VWF), another crucial clotting protein.

For the hemophilia community, the availability of CRYOcheck Factor VIII Deficient Plasma with VWF is a major advancement. It is anticipated to increase FVIII activity monitoring’s precision and consistency, which may help control hemophilia A more effectively and lower the chance of bleeding episodes.

For the hemophilia community, the availability of a standardized plasma product for FVIII activity testing is an important advance. It will support ensuring that patients receive accurate results and that the management of their treatment is successful.

What relevance does this news have?

This information is crucial because it offers a fresh method for keeping track of FVIII activity in hemophilia A patients. Ensuring that patients receive the appropriate dosage of replacement medication and that their treatment is effective requires accurate monitoring of FVIII activity.

FVIII activity testing can be conducted using the standardized plasma product CRYOcheck Factor VIII Deficient Plasma with VWF. This implies that it will yield consistent results across labs, enhancing the precision of therapy and monitoring.

The availability of this new medicine is especially welcome news for hemophilia A sufferers residing in underprivileged or rural locations. These patients may not have had easy access to FVIII activity testing in the past due to reagent shortages in their local laboratories. These patients can now receive convenient, accurate monitoring of their FVIII activity thanks to CRYOcheck Factor VIII Deficient Plasma with VWF.

What does this entail for hemophilia A patients?

The creation of CRYOcheck Factor VIII Deficient Plasma with VWF is a step in the right direction for those who have hemophilia A. It offers a fresh and enhanced instrument for tracking FVIII activity, which is necessary for a successful course of therapy.

Hemophilia A patients can anticipate improved disease management and more precise monitoring with this new medicine. This may result in several advantages, such as:

• A lower chance of hemorrhaging incidents

• A higher standard of living

• A longer lifespan

Next, what?

In the US, CRYOcheck Factor VIII Deficient Plasma with VWF is currently accessible for usage in laboratories. In the upcoming months, it is anticipated that the product will become more extensively accessible.

Speak with your physician about CRYOcheck Factor VIII Deficient Plasma with VWF availability and potential benefits if you have hemophilia A.