Siemens Healthcare Diagnostics Gmbh

Peter J Hamer

Walter P Carney

Allan Lipton

Kim Leitzel

Suhail M Ali

Sheryl Brown-Shimer

Karen Pierce

James Elting

Leticia Morris

The present invention describes clinically and medically important methods of examining, screening over time, and monitoring the outcome of a cancer patient who is undergoing treatment or therapy for his or her disease. More specifically, the invention provides a method of monitoring the progression of disease, or the effectiveness of cancer treatment, in a cancer patient by measuring the levels of one or more analytes of the plasminogen activator (uPA) system, namely, uPA, PAI-1 and the complex of uPA:PAI-1, in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment. As a result of performing the method, an increase or elevation in the levels of one or more of the PA system analytes in the cancer patient compared with the levels one or more of the respective PA system analytes in normal control individuals serves as an indicator of cancer advancement or progression and/or a lack of treatment effectiveness for the patient.

Assays for cancer patient monitoring based on levels of analyte components of the plasminogen activator system in body fluid samples

The present invention describes clinically and medically important methods of monitoring the outcome of a cancer patient who is suffering from disease or who is undergoing treatment or therapy for his or her disease. More specifically, the invention provides a method of monitoring the progression of disease or cancer treatment effectiveness in a cancer patient by measuring the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment, wherein a decrease in the level of the ECD of the EGFR in the cancer patient compared with the level of the ECD of the EGFR in normal control individuals serves as an indicator of cancer advancement or progression and/or a lack of treatment effectiveness for the patient. As another aspect of determining disease outcome and survival, the invention further provides assessing both EGFR and HER-2/neu levels, in combination, in a patient sample. A finding of decreased levels of EGFR concomitantly with elevated or increased levels of HER-2/neu relative to control levels indicates poor outcome and short time to progression.

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

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Reading, MA, United States of America

Peter J Hamer