Claims for Patent: 8,012,480

Summary for Patent: 8,012,480

Title:	Detection of proteins from circulating neoplastic cells
Abstract:	The protein EGFR, ERCC1, RRM1, thymidylate synthase, or beta-tubulin from cancer cells is detected in a blood sample by enriching the cancer cells from the blood sample followed by performing on the enriched cancer cells an immunoassay capable of detecting the proteins mentioned above. Cancer patients overexpressing EGFR are treated with an anti-EGFR agent, for example cetuximab, panitumumab, erlotinib or gefitinib.
Inventor(s):	Lorence; Robert M. (Bethesda, MD)
Assignee:	Wellstat Biologics Corporation (Gaithersburg, MD)
Application Number:	12/297,420
Patent Claims:	1. A method of assaying a protein from cancer cells in a blood sample comprising enriching the cancer cells from the blood sample followed by lysing the enriched cells and performing on the lysed cancer cells an immunoassay capable of detecting the protein from the cancer cells; wherein the immunoassay uses electrochemiluminescence for detection the immunoassay has a sensitivity defined by being capable of quantifiably detecting the protein from thirty cancer cells per milliliter of blood or by being capable of detecting sixty-four picograms of the protein; and the protein is selected from the group consisting of epidermal growth factor receptor, excision repair cross-complementation group 1, ribonucleotide reductase subunit M1, thymidylate synthase, and beta-tubulin; and the immunoassay generates a signal proportional to the number of molecules of the protein present in the cancer cells in the blood sample. 2. A method of detecting the expression of a protein from cancer cells in a blood sample comprising isolating the cancer cells from the blood sample followed by making an extract from the isolated cancer cells followed by performing on the extract an immunoassay capable of detecting the protein, in which a positive immunoassay result indicates the presence of the protein in the cancer cells; wherein the immunoassay uses electrochemiluminescence for detection the protein is epidermal growth factor receptor; and the immunoassay has a sensitivity defined by being capable of detecting the protein from thirty cancer cells per milliliter of blood or by being capable of detecting sixty-four picograms of the protein. 3. The method of claim 1, wherein the immunoassay is capable of detecting the protein from ten cancer cells per milliliter of blood. 4. The method of claim 3, wherein the immunoassay is capable of detecting the protein from three cancer cells per milliliter of blood. 5. The method of claim 1, wherein the immunoassay is capable of detecting four picograms of the protein. 6. A method of treating a cancer patient likely to benefit from treatment with an anti-EGFR agent, comprising administering the agent to the patient whose blood sample tested positive for epidermal growth factor receptor in the method of claim 1. 7. The method of claim 6 wherein the agent is selected from the group consisting of cetuximab, panitumumab, erlotinib, and gefitinib. 8. The method of claim 2, wherein the immunoassay is capable of detecting the protein from ten cancer cells per milliliter of blood. 9. The method of claim 8, wherein the immunoassay is capable of detecting the protein from three cancer cells per milliliter of blood. 10. The method of claim 2, wherein the immunoassay is capable of detecting four picograms of the protein. 11. A method of treating a cancer patient likely to benefit from treatment with an anti-EGFR agent, comprising administering the agent to the patient whose blood sample tested positive in the method of claim 2. 12. The method of claim 11 wherein the agent is selected from the group consisting of cetuximab, panitumumab, erlotinib, and gefitinib.

Details for Patent 8,012,480

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2039-02-26
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2039-02-26
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2039-02-26