Claims for Patent: 9,963,748

Summary for Patent: 9,963,748

Title:	Methods and compositions for classifying DLBCL
Abstract:	Provided herein are methods and compositions to classify DLBCL subtypes using quantitative RT-PCR.
Inventor(s):	Dua; Rajiv (Manteca, CA), Fontecha; Marcel (San Ramon, CA), Li; Yan (Palo Alto, CA), Liu; Wei-min (Dublin, CA), Santini; Christopher (Pleasant Hill, CA), Steiner; Lori (Alameda, CA), Tai; Yu Chuan (Pleasanton, CA)
Assignee:	Roche Molecular Systems, Inc. (Pleasanton, CA)
Application Number:	15/592,471
Patent Claims:	1. A method of providing treatment for an individual with diffuse large B cell lymphoma (DLBCL) comprising: (a) obtaining a sample from the individual (DLBCL sample); (b) detecting by qRT-PCR the expression of germinal center B cell (GCB) markers ZNF318, PTK2, and SSBP2 in the DLBCL sample; (c) detecting by qRT-PCR the expression of activated B cell (ABC) markers CCND2, FOXP1, and JADE3 in the DLBCL sample; (d) detecting by qRT-PCR the expression of a control gene in the DLBCL sample; and (e) providing treatment for the individual, (i) wherein the treatment comprises R-CHOP (rituximab or etoposide; cydophosphamide; doxorubicin; vincristine; and prednisolone) if the ratio of GCB marker expression to ABC marker expression is higher than a GCB threshold value; or (ii) wherein the treatment comprises an alternative therapy if the ratio of ABC marker expression to GCB marker expression is higher than an ABC threshold value. 2. The method of claim 1, wherein the GCB threshold value is set based on the ratio of GCB marker expression to ABC marker expression in a GCB positive control. 3. The method of claim 1, wherein the ABC threshold value is set based on ABC marker expression to GCB marker expression in an ABC positive control. 4. The method of claim 1, wherein the sample is a from a lung biopsy or bronchoalveolar lavage. 5. The method of claim 1, wherein the sample is formalin-fixed paraffin embedded tissue (FFPET). 6. The method of claim 1, wherein the sample is blood, plasma, or serum. 7. The method of claim 1, wherein the detecting of (b) and (c) are carried out in multiplex in multiple vessels. 8. The method of claim 7, wherein each GCB and ABC marker is individually detected. 9. The method of claim 1, wherein the detecting of (b) is carried out in a single vessel for each sample. 10. The method of claim 1, wherein the detecting of (c) is carried out in a single vessel for each sample. 11. The method of claim 1, wherein the detecting of (d) is carried out in the same vessel(s) as the detecting of (b) and (c). 12. The method of claim 1, wherein the alternative therapy includes a BTK inhibitor, SYK inhibitor, NFkB inhibitor, or immunomodulatory agent. 13. The method of claim 12, wherein the alternative therapy further includes R-CHOP. 14. The method of claim 1, comprising adjusting the level of expression detected for the genes in steps (b) and (c) based on the expression detected of the control gene in (d). 15. A kit comprising: (a) a mixture comprising a primer set and a fluorescently labeled probe that specifically amplifies and detects each of germinal center B cell (GCB) marker ZNF318, PTK2, and SSBP2 gene products; and (b) a mixture comprising a primer set and a fluorescently labeled probe that specifically amplifies and detects each of activated B cell (ABC) marker CCND2, FOXP1, and JADE3 gene products. 16. The kit of claim 15, wherein the mixtures of (a) and (b) each further comprise a primer set and a fluorescently labeled probe that specifically amplifies and detects a control gene product, wherein the fluorescently labeled probe that specifically detects the control gene product is differently labeled than the fluorescently labeled probes in mixture (a) and mixture (b). 17. The kit of claim 15, wherein the fluorescently labeled probes in mixture (a) are all labeled with the same fluorescent label. 18. The kit of claim 15, wherein the fluorescently labeled probes in mixture (b) are all labeled with the same fluorescent label. 19. The kit of claim 15, further comprising reverse transcriptase and/or thermostable DNA polymerase. 20. The kit of claim 15, further comprising an enzyme with both reverse transcriptase and DNA polymerase activity. 21. The kit of claim 15, further comprising at least one control sample.

Details for Patent 9,963,748

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2036-05-13
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2036-05-13