	US 11,988,658 B2
	Methods of assessing cellular breast samples and compositions for use in practicing the same
Keith Shults, Nolensville, TN (US); Amanda Noel Chargin, San Jose, CA (US); and Seyedhamed Jafarianmohamady, Murfreesboro, TN (US)
Assigned to IncellDx, Inc., Hayward, CA (US)
Filed by IncellDx, Inc., San Carlos, CA (US)
Filed on Mar. 11, 2020, as Appl. No. 16/815,475.
Application 16/815,475 is a division of application No. 15/164,778, filed on May 25, 2016, granted, now 10,627,389.
Claims priority of provisional application 62/166,583, filed on May 26, 2015.
Prior Publication US 2020/0271638 A1, Aug. 27, 2020
Int. Cl. G01N 33/483 (2006.01); C12Q 1/6886 (2018.01); G01N 33/50 (2006.01); G01N 33/574 (2006.01)

CPC G01N 33/4833 (2013.01) [C12Q 1/6886 (2013.01); G01N 33/5044 (2013.01); G01N 33/5094 (2013.01); G01N 33/57415 (2013.01); C12Q 2600/158 (2013.01); G01N 2333/71 (2013.01); G01N 2333/723 (2013.01)]

11 Claims

1. A method of assessing a cellular breast sample, the method comprising:

a) flow cytometrically analyzing the cellular breast sample to obtain:

i) sample data comprising sample cell count data;

ii) epithelial cell data comprising DNA content data, epithelial cell count data and cancer biomarker data; and

iii) white blood cell (WBC) data comprising WBC proliferation data; and

b) evaluating the flow cytometrically obtained:

sample data by comparing the sample cell count data to a reference value,

epithelial cell data by comparing one or more of the DNA content data, epithelial cell count data, and cancer biomarker data to reference values, and

WBC data by comparing the WBC proliferation data to a reference value to assess the cellular breast sample.