US 12,215,390 B2
Integration of tumor characteristics with breast cancer index
Yi Zhang, San Diego, CA (US); and Catherine A. Schnabel, San Diego, CA (US)
Assigned to BIOTHERANOSTICS, INC., San Diego, CA (US)
Filed by BIOTHERANOSTICS, INC., San Diego, CA (US)
Filed on Nov. 18, 2022, as Appl. No. 18/056,967.
Application 18/056,967 is a division of application No. 15/349,915, filed on Nov. 11, 2016, granted, now 11,530,448.
Claims priority of provisional application 62/265,964, filed on Dec. 10, 2015.
Claims priority of provisional application 62/255,260, filed on Nov. 13, 2015.
Prior Publication US 2023/0083179 A1, Mar. 16, 2023
Int. Cl. C12Q 1/6886 (2018.01); A61K 31/337 (2006.01); A61K 31/513 (2006.01); A61K 31/675 (2006.01); A61K 31/704 (2006.01); A61K 45/06 (2006.01)
CPC C12Q 1/6886 (2013.01) [A61K 31/337 (2013.01); A61K 31/513 (2013.01); A61K 31/675 (2013.01); A61K 31/704 (2013.01); A61K 45/06 (2013.01); C12Q 2600/106 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01)] 20 Claims
 
1. A method of treating breast cancer of a subject who is lymph node-positive, the method comprising
(i) determining that the subject has an MGIN+ score above an MGIN+ score cut point by:
assaying or having assayed a sample of breast cancer cells from the subject for the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2;
summing or having summed the expression levels of BUB1B, CENPA, NEK2, RACGAP1 and RRM2 as a single index into a subject's MGI index;
determining or having determined one or more clinicopathological factor selected from tumor size and grade of the subject's breast cancer;
calculating or having calculated the MGIN+ score of the subject by combining the subject's MGI index with the one or more clinicopathological factor of the subject using a multivariate Cox-proportional model;
comparing or having compared the subject's MGIN+ score to the MGIN+ score cut point, wherein the MGIN+ score cut point has been pre-determined based on the MGIN+ scores calculated for a training set of samples containing breast cancer tissues from patients who had breast cancer recurrence and patients who did not have breast cancer recurrence; and
(ii) treating the subject with an MGIN+ score above the MGIN+ cut point with chemotherapy or endocrine therapy.