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Biomarker Development
PGxHealth has developed industry leading know-how and experience in translating the science relating to genetic marker discovery to valuable applications in the clinical setting. The division is accustomed to discovering and in-licensing proprietary markers including but not limited to those in CNS, cardiovascular disease, and oncology. Once the genetic marker is known, and clinical utility is evident, PGxHealth has the experience to validate and commercialize genetic tests based on these markers. The genetic markers that are developed and included in PGxHealth’s test catalog are chosen for commercialization based on PGxHealth’s assessment of their economic and clinical value to the key consumers of these tests (including patients, providers, payors). In addition, we work directly with those developing therapeutics to identify genetic markers, and incorporate the markers into their commercialization plan; PGxHealth is positioned to commercialize the resultant genetic tests for our clients as well in the same manner we commercialize our own genetic tests. PGxHealth is committed to funding in licensing, development and commercialization of these genetic tests, but will continue to work with others to accelerate discovery and development where a strategic fit exists.
Why Monoclonal Antibodies
Therapeutic monoclonal antibodies of the Immunoglobulin G1 (IgG1) subtype exert their influence by binding to specific targets as well as recruiting immune effector cells to inhibit disease progression. It is well accepted that genes in the FC Gamma Receptor (FCGR) cluster modulate immune response, therefore variants in these genes will likely influence the outcomes of patients treated with monoclonal antibodies. The impact of FCGR3A polymorphisms on the binding of IgG1 monoclonal antibodies to immune effector cells has been well documented in vitro, and has been shown to influence response of patients with follicular NHL to rituximab in several clinical studies. In oncology, these markers can be used with tumor-based markers such as K-RAS, HER-2, and others to provide improved predictors of drug response. It is probable that variants in FCGR3A and other related genes will facilitate the optimal selection of drugs for patients with various forms of cancer, as well as autoimmune diseases such as rheumatoid arthritis, or any disease where IgG1 monoclonal antibodies are a mainstay of treatment.
Example: PGxPredict:RITUXIMAB for Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is the fifth leading cause of new cancer cases in the United States, with approximately 66,000 diagnosed in 2008 (American Cancer Society), including both indolent and aggressive forms. Follicular NHL is an indolent lymphoma with a median survival of 8-10 years. The preferred first-line treatment for follicular NHL is chemotherapy in combination with rituximab.1 Although response rates overall are higher when rituximab is given in combination with chemotherapy rather than alone,2 excellent efficacy has been achieved in some individuals who are administered rituximab as a single-agent.3,4 Thus, a subset of patients could be effectively treated with rituximab monotherapy while being spared the added cost and toxicity of chemotherapy, if that subset could be reliably identified. In fact, a genetic variant of FCGR3A has been shown to be capable of selecting those follicular lymphoma patients who could benefit from rituximab monotherapy.5,6
References:
1. NCCN Practice Guidelines in Oncology v.1.2009. http://www.nncn.org. 2009. 3-11-2009.
2. Schulz H, et al. J Natl Cancer Inst 2007; 99(9):706-714.
3. McLaughlin P, et al. J Clin Oncol 1998; 16(8):2825-2833.
4. Hainsworth JD, et al. J Clin Oncol 2005; 23(6):1088-1095.
5 . Cartron G, et al. Blood 2002; 99(3):754-758.
6 . Weng WK, Levy R. J Clin Oncol 2003; 21(21):3940-3947. |
PGxPredict:RITUXIMAB -
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