US 12,345,703 B2
Assay for JC virus antibodies
Leonid Gorelik, Quincy, MA (US); Kenneth J. Simon, Cambridge, MA (US); Meena Subramanyam, Stoneham, MA (US); and Mia Marie Rushe, Everrett, MA (US)
Assigned to Biogen MA Inc., Cambridge, MA (US)
Filed by Biogen MA Inc., Cambridge, MA (US)
Filed on Mar. 25, 2022, as Appl. No. 17/705,092.
Application 15/063,777 is a division of application No. 13/521,311, granted, now 9,316,641, issued on Apr. 19, 2016, previously published as PCT/US2011/020832, filed on Jan. 11, 2011.
Application 17/705,092 is a continuation of application No. 16/594,843, filed on Oct. 7, 2019, granted, now 11,287,423.
Application 16/594,843 is a continuation of application No. 15/063,777, filed on Mar. 8, 2016, granted, now 10,444,234, issued on Oct. 15, 2019.
Claims priority of provisional application 61/316,193, filed on Mar. 22, 2010.
Claims priority of provisional application 61/294,048, filed on Jan. 11, 2010.
Prior Publication US 2022/0397571 A1, Dec. 15, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/543 (2006.01)
CPC G01N 33/54306 (2013.01) 30 Claims
OG exemplary drawing
 
1. A method of evaluating a subject for presence of JC virus (JCV) antibodies, the method comprising:
a) contacting a biological sample obtained from a subject with highly purified virus-like particles (HPVLPs) consisting essentially of the VP1 protein of the JCV, in solution under conditions suitable for binding of a JCV antibody in the sample to an HPVLP, thereby providing a pre-incubated sample;
b) contacting the pre-incubated sample with HPVLPs, consisting essentially of the VP1 protein of the JCV, immobilized on a solid substrate under conditions suitable for binding of a JCV antibody in the sample to an HPVLP;
c) detecting the level of JCV antibody in the pre-incubated sample binding to the immobilized HPVLPs;
d) contacting a portion of the biological sample that was incubated in solution without HPVLPs under the same conditions used for step (b), and detecting the level of JCV antibody binding to the immobilized HPVLP; and
e) comparing the detected level of JCV antibody in the pre-incubated sample of steps (a) to (c) to the level of JCV antibody detected in the sample of step (d);
wherein a decrease above a specified percentage in the detected level of JCV antibody in the pre-incubated sample compared to the sample obtained from the subject that was incubated in solution without HPVLPs indicates that the sample is positive for JCV antibody, and a decrease in the detected level of JCV antibody below a specified percentage indicates that there is no JCV-specific antibody present in the sample; and wherein the subject is identified as being at an increased risk for Progressive Multifocal Leukoencephalopathy (PML) if a biological sample obtained from the subject is positive for JCV antibodies.