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US 11,747,351 B2Granted
Assays to monitor bleeding disorders
AssigneeBioverativ Therapeutics Inc.
InventorsJurg Sommer, Haiyan Jiang, Xin Zhang, Buyue Yang, Glenn Pierce
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Abstract
The present invention provides methods of dosing Factor VIII or Factor IX chimeric and hybrid polypeptides. The present invention further provides high-sensitivity methods of quantifying an amount of activated FIX protein in a test sample.
Claims15
A method of quantifying an amount of protein capable of exhibiting FIX activity which is in its activated form (activated FIX protein) in a test sample, the method comprising:
- (i) measuring thrombin generation activity for the test sample in the presence of FIX-deficient plasma or FIX-deficient blood and in the presence of exogenous thrombin, wherein the exogenous thrombin is present at a concentration of about 5 nM, and
- (ii) comparing the thrombin generation activity to a standard curve plotting known activated FIX protein levels to thrombin generation activity;
- wherein the measuring is performed in the absence of exogenous tissue factor (TF).
Dependencies are inferred from the claim text.