Claims for Patent: 7,655,428

Summary for Patent: 7,655,428

Title:	Latent protein C assays and their uses for diagnosis and/or prognosis in systemic inflammatory response syndromes
Abstract:	The present invention relates to methods and compositions for measuring latent protein C in test samples, particularly patient samples. The methods and compositions described are sensitive for latent protein C, relative to activated protein C.
Inventor(s):	Valkirs; Gunars E. (Escondido, CA), Buechler; Joseph A. (Carlsbad, CA), Lee; Seok-Won (San Diego, CA), Veeramallu; Uday Kumar (San Diego, CA)
Assignee:	Biosite, Inc. (Waltham, MA)
Application Number:	11/614,836
Patent Claims:	1. An immunoassay method for detection of latent protein C in a sample of bodily fluid obtained from a patient, comprising: contacting the sample of bodily fluid with an antibody that specifically binds to latent protein C, wherein the antibody does not significantly cross-react with activated protein C, and wherein the antibody is a monoclonal antibody that competes with an antibody comprising a heavy chain variable region having an amino acid sequence of SEQ ID NO:6 and a light chain variable region having an amino acid sequence of SEQ ID NO:7 for specific binding to latent protein C; detecting an amount of antibody bound to latent protein C present in the sample; and calculating the amount of latent protein C present in the sample based on the amount of antibody detected. 2. The method of claim 1, wherein the patient is a human. 3. The method of claim 2, wherein the patient is a patient having or suspected of having systemic inflammatory response syndrome (SIRS). 4. The method of claim 1, wherein the immunoassay method is a sandwich immunoassay method. 5. The method of claim 4, wherein the contacting step comprises contacting the test sample with a first antibody conjugated to a solid phase and a second antibody conjugated to a signal development element, wherein one or both of the first and second antibodies are sensitive for latent protein C relative to activated protein C, and wherein the signal generated is indicative of protein bound to both the first and second antibodies. 6. The method of claim 1, wherein the immunoassay method is a competitive immunoassay method. 7. The method of claim 6, wherein the contacting step comprises contacting the test sample with latent protein C conjugated to a solid phase and an antibody conjugated to a signal development element, wherein the antibody is sensitive for latent protein C relative to activated protein C. 8. The method of claim 6, wherein the contacting step comprises contacting the test sample with latent protein C conjugated to a signal development element and an antibody conjugated to a solid phase wherein the antibody is sensitive for latent protein C relative to activated protein C. 9. The method of claim 1, wherein the signal is generated electrochemically. 10. The method of claim 9, wherein the signal is generated using an antibody-based biosensor. 11. The method of claim 1, wherein the signal is generated optically. 12. The method of claim 11, wherein the signal is generated using a fluorometer. 13. The method of claim 1, wherein the sample of bodily fluid is a blood, serum, or plasma sample. 14. The method of claim 1, wherein the immunoassay is configured to generate a detectable signal when latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO:1 is present at a concentration between 1 .mu.g/mL and 5 .mu.g/mL. 15. The method of claim 1, wherein the immunoassay is configured to generate a detectable signal from 3 .mu.g/mL of latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO: 1 that is at least about 5 fold greater than a signal obtained from an equimolar amount of active protein C. 16. The method of claim 1, wherein the immunoassay is configured to generate a detectable signal from 3 .mu.g/mL of latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO: 1 that is at least about 10 fold greater than a signal obtained from an equimolar amount of active protein C. 17. The method of claim 1, wherein the immunoassay is configured to generate a detectable signal from 3 .mu.g/mL of latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO: 1 that is at least about 25 fold greater than a signal obtained from an equimolar amount of active protein C. 18. The method of claim 1, wherein the immunoassay is configured to generate a detectable signal from 3 .mu.g/mL of latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO: 1 that is at least about 5 fold greater than a signal obtained from an equimolar amount of active protein C, and to generate a detectable signal when latent protein C having the sequence depicted by residues 43-461 of SEQ ID NO: 1 is present at a concentration between 1 .mu.g/mL and 5 .mu.g/mL. 19. The method of claim 1, wherein the sample contains a chelating agent. 20. The method of claim 17, wherein the antibody is a human, humanized, chimeric or veneered antibody. 21. The method of claims 1 or 13, wherein the activated protein C is endogenous to the patient from which the sample was obtained. 22. The method of claims 1 or 13, wherein the activated protein C has been administered to the patient as a pharmaceutical preparation. 23. The method of claim 22, wherein the pharmaceutical preparation is drotrecogin alfa.

Details for Patent 7,655,428

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	XIGRIS	drotrecogin alfa	Injection	125029	November 21, 2001	7,655,428	2026-12-21