US 12,066,442 B2
Method of assessing risk of PML
Gary Lewis Bloomgren, Concord, MA (US); Carmen Bozic, Newton, MA (US); Sophia Lee, Waltham, MA (US); Meena Subramanyam, Stoneham, MA (US); and Tatiana Plavina, North Reading, MA (US)
Assigned to Biogen MA Inc., Cambridge, MA (US)
Filed by Biogen MA Inc., Cambridge, MA (US)
Filed on Aug. 3, 2021, as Appl. No. 17/393,335.
Application 17/393,335 is a division of application No. 16/211,154, filed on Dec. 5, 2018.
Application 16/211,154 is a continuation of application No. 14/122,754, abandoned, previously published as PCT/US2012/040283, filed on May 31, 2012.
Claims priority of provisional application 61/636,588, filed on Apr. 20, 2012.
Claims priority of provisional application 61/550,257, filed on Oct. 21, 2011.
Claims priority of provisional application 61/508,584, filed on Jul. 15, 2011.
Claims priority of provisional application 61/491,810, filed on May 31, 2011.
Prior Publication US 2022/0011310 A1, Jan. 13, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/569 (2006.01)
CPC G01N 33/56983 (2013.01) [C12N 2710/22011 (2013.01); G01N 2333/025 (2013.01); G01N 2469/20 (2013.01); G01N 2800/28 (2013.01); G01N 2800/2814 (2013.01); G01N 2800/50 (2013.01); G01N 2800/52 (2013.01)] 20 Claims
 
1. A method of treating a Multiple Sclerosis (MS) patient, the method comprising acquiring the result of an assay for detecting JC Virus (JCV) antibodies in a biological sample from the patient, and responsive to a determination that the sample is negative for anti-JCV antibodies, administering an anti-VLA-4 therapy, wherein the assay comprises:
a) forming a first reaction mixture comprising a first aliquot of said sample and a substrate on which is disposed highly purified viral-like particles (HPVLP);
b) detecting the level of anti-JCV antibody bound to said substrate on which is disposed HPVLP by detecting a labeled detection reagent bound to anti-JCV antibody bound to said substrate, evaluating a cut-off calibrator having a normalized optical density (nOD) of about 1, a positive control having a nOD of about 1.3, and a negative control having a nOD of about 0.1, and assigning to the sample a value indicative of the level of anti-JCV antibody;
c) responsive to a level of anti-JCV antibody corresponding to a nOD value between 0.2 and 0.4 in step b), forming a second reaction mixture containing a second aliquot of said sample preincubated with solution-phase HPVLP, and detecting the level of unbound antibody in said second reaction mixture, by detecting anti-JCV antibody capable of binding with a substrate on which is disposed HPVLP;
d) forming a third reaction mixture containing a third aliquot of said sample preincubated in the absence of solution-phase HPVLP, and detecting the level of unbound anti-JCV antibody in the third reaction mixture by detecting anti-JCV antibody capable of binding with a substrate on which is disposed HPVLP; and
e) determining the level to which the presence of solution-phase HPVLP in the second reaction mixture inhibits the level of unbound anti-JCV antibody in said second reaction as compared with the level of unbound antibody in said third reaction mixture, wherein said sample is classified as negative when said inhibition is less than 45%.