	US 7,473,534 B2
	Assays for cancer patient monitoring based on levels of epidermal growth factor receptor (EGFR) extracellular domain (ECD) analyte, alone or in combination with other analytes, in body fluid samples
Walter P. Carney, North Andover, Mass. (US); Peter J. Hamer, Reading, Mass. (US); Allan Lipton, Hershey, Pa. (US); Kim Leitzel, Hummelstown, Pa. (US); and Suhail M. Ali, Hershey, Pa. (US)
Assigned to Siemens Healthcare Diagnostics Inc., Tarrytown, N.Y. (US)
Filed on Feb. 27, 2003, as Appl. No. 10/375,371.
Claims priority of provisional application 60/360678, filed on Mar. 01, 2002.
Claims priority of provisional application 60/429487, filed on Nov. 27, 2002.
Prior Publication US 2003/0219842 A1, Nov. 27, 2003
Int. Cl. G01N 33/574 (2006.01)

U.S. Cl. 435—7.23 [435/4]

9 Claims

1. A method of aiding in the prediction of overall patient survival in a breast cancer patient, comprising:

(a) measuring the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in a serum or plasma sample of the breast cancer patient;

(b) measuring the level of the HER-2/neu receptor in the same serum or plasma sample of the breast cancer patient; and

(c) determining, in combination, (i) if the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) is decreased compared to the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in normal controls; and (ii) if the level of the HER-2/neu receptor is elevated compared to the level of HER-2/neu in normal controls;

wherein the normal range of the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in normal controls is about 45 to 78 ng/ml and the normal level of HER-2/neu in controls is less than about 15 ng/ml; and further wherein a decrease in the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) compared to the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in normal controls and an elevation in the level of HER-2/neu compared to the level of HER-2/neu in normal controls in the breast cancer patient sample indicates the shorter overall survival for the patient.