US 11,726,089 B2
Methods of assaying neoplastic and neoplasia-related cells and uses thereof
Bruce K. Patterson, Palo Alto, CA (US); Amanda Noel Chargin, San Jose, CA (US); and Keith Shults, Nolensville, TN (US)
Assigned to IncellDx, Inc., San Carlos, CA (US)
Appl. No. 16/959,355
Filed by IncellDx, Inc., San Carlos, CA (US)
PCT Filed Jan. 2, 2019, PCT No. PCT/US2019/012074
§ 371(c)(1), (2) Date Jun. 30, 2020,
PCT Pub. No. WO2019/136082, PCT Pub. Date Jul. 11, 2019.
Application 16/959,355 is a continuation in part of application No. 15/861,352, filed on Jan. 3, 2018, granted, now 10,782,298.
Application 15/861,352 is a continuation in part of application No. PCT/US2017/050322, filed on Sep. 6, 2017.
Claims priority of provisional application 62/384,037, filed on Sep. 6, 2016.
Prior Publication US 2021/0063399 A1, Mar. 4, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/6886 (2018.01); G01N 33/574 (2006.01); G01N 15/14 (2006.01)
CPC G01N 33/57423 (2013.01) [C12Q 1/6886 (2013.01); G01N 15/1434 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01); G01N 2333/70532 (2013.01)] 7 Claims
 
1. A method of detecting whether a neoplastic cell having a heterogeneity index above a predetermined threshold is present in a neoplasia sample, the method comprising:
contacting the neoplasia sample with a labeled binding member specific for programmed death ligand 1 (PD-L1) to generate a labeled cell suspension;
cytometrically assaying the labeled cell suspension to obtain a per cell heterogeneity index comprising quantifying a number of PD-L1 molecules expressed per cell to detect whether a neoplastic cell that has a heterogeneity index above a predetermined threshold is present in the neoplasia sample.