Claims for Patent: 8,697,373

Summary for Patent: 8,697,373

Title:	Reagents and methods for use in cancer diagnosis, classification and therapy
Abstract:	Methods and reagents for classifying HER2+ breast tumors and for identifying new HER2+ breast tumor classes and subclasses. Methods for correlating tumor class or subclass with therapeutic regimen or outcome, for identifying appropriate (new or known) therapies for particular classes or subclasses, and for predicting outcomes based on class or subclass. New therapeutic agents and methods for the treatment of HER2+ breast cancer.
Inventor(s):	Ring; Brian Z. (Foster City, CA), Ross; Douglas T. (Burlingame, CA), Seitz; Robert S. (Hampton Cove, AL)
Assignee:	Clarient Diagnostic Services, Inc. (Aliso Viejo, CA)
Application Number:	12/444,007
Patent Claims:	1. A method comprising steps of: obtaining a tumor sample from a patient having an HER2+ breast tumor; contacting the tumor sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C); and assessing the patient's likely prognosis based upon binding of the first antibody to the tumor sample, wherein binding of the first antibody correlates with a higher likelihood that the patient will have a poor outcome. 2. The method of claim 1 further comprising: providing a positive control sample; and contacting the positive control sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C), wherein the step of assessing the patient's likely prognosis comprises a step of comparing the binding of the first antibody to the tumor sample with the binding of the first antibody to the positive control sample. 3. The method of claim 1, wherein the first antibody is a monoclonal antibody. 4. The method of claim 1 further comprising: determining from the binding of the first antibody that the patient's prognosis is poor and administering a breast cancer therapeutic to the patient. 5. The method of claim 4, wherein the breast cancer therapeutic is Trastuzumab. 6. The method of claim 1 further comprising: confirming the breast tumor is positive for HER2. 7. The method of claim 6, wherein the breast tumor is confirmed to be positive for HER2 by imunohistochemistry. 8. The method of claim 6, wherein the breast tumor is confirmed to be positive for HER2 by in situ hybridization. 9. The method of claim 1 further comprising: contacting the tumor sample with a second antibody directed to estrogen receptor, wherein in the step of assessing, the patient's likely prognosis is assessed based upon binding of the first and second antibodies to the tumor sample, wherein binding of the second antibody correlates with a higher likelihood that the patient will have a good outcome. 10. The method of claim 9, wherein binding of the second antibody correlates with a lower likelihood that the patient will have a recurrence. 11. The method of claim 9, wherein binding of the second antibody correlates with a higher likelihood that the patient will survive for a period of time. 12. The method of claim 1, wherein binding of the first antibody correlates with a higher likelihood that the patient will have a recurrence. 13. The method of claim 1, wherein binding of the first antibody correlates with a lower likelihood that the patient will survive for a period of time. 14. A method comprising steps of: obtaining a tumor sample from a patient having an HER2+ breast tumor; contacting the tumor sample with a first antibody directed to HTF9C (Hpall tiny fragments locus 9C); and classifying the HER2+ breast tumor based upon binding or nonbinding of the first antibody to HTF9C (Hpall tiny fragments locus 9C) in the tumor sample. 15. The method of claim 14 further comprising: contacting the tumor sample with a second antibody directed to estrogen receptor, wherein in the step of classifying, the HER2+ breast tumor is classified based upon binding or nonbinding of the first antibody to HTF9C (Hpall tiny fragments locus 9C) in the tumor sample and based on binding or nonbinding of the second antibody to estrogen receptor in the tumor sample.

Details for Patent 8,697,373

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-02-26
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-02-26
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-02-26