US 11,747,351 B2
Assays to monitor bleeding disorders
Jurg Sommer, Wayland, MA (US); Haiyan Jiang, Belmont, MA (US); Xin Zhang, Weston, MA (US); Buyue Yang, Arlington, MA (US); and Glenn Pierce, Rancho Santa Fe, CA (US)
Assigned to BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed by BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed on Apr. 14, 2020, as Appl. No. 16/848,445.
Application 16/848,445 is a division of application No. 14/234,789, granted, now 10,656,167, previously published as PCT/US2012/048191, filed on Jul. 25, 2012.
Claims priority of provisional application 61/668,911, filed on Jul. 6, 2012.
Claims priority of provisional application 61/596,902, filed on Feb. 9, 2012.
Claims priority of provisional application 61/568,986, filed on Dec. 9, 2011.
Claims priority of provisional application 61/522,560, filed on Aug. 11, 2011.
Claims priority of provisional application 61/511,207, filed on Jul. 25, 2011.
Prior Publication US 2020/0386774 A1, Dec. 10, 2020
Int. Cl. G01N 33/86 (2006.01); C12N 9/64 (2006.01)
CPC G01N 33/86 (2013.01) [C12N 9/644 (2013.01); G01N 2333/755 (2013.01); G01N 2333/9645 (2013.01); G01N 2333/974 (2013.01)] 15 Claims
 
1. 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).