Company Profile: N-Of-One: Realizing Personalized Medicine

Abstract

N-of-One is at the forefront of personalized medicine. The company's mission is to act as a bridge between the research community, diagnostic laboratories, the treating oncologist and the patient to develop customized cancer diagnostic and treatment strategies. N-of-One provides physicians and patients with relevant insight regarding molecular profiling technologies and facilitates rapid, high-quality testing of patient tissues. In addition to expanding treatment options, the services provided by N-of-One potentially provide cost savings by guiding patients and physicians toward more evidence-based, data-driven treatment approaches.

Molecular markers for breast cancer diagnosis, prognosis and targeted therapy

“…While several genomic prediction assays have been reported in breast cancer to assist in predicting response to therapy [25,[41][42][43][44][45][46][47], some examples exist where biotechnology companies seek to participate in personalized medicine via molecular profiling of reftractory cancers or referral of patients to national clinical trials based on biomarker profiles, such as the Translational Genomics Research Institute (Phoenix, AZ), Caris Life Sciences (Phoenix, AZ) and N-of-One (Lexington, MA) [43,96]. For example, Von Hoff et al profiled metastatic tumors from patients with refractory cancers of various types of cancer using FFPE tissue for IHC, FISH, and fresh frozen tissue for microarrays [96].…”

“…Several gene expression signatures based on various cohorts (many with test and training datasets) have been published demonstrating the ability to classify breast cancers into high risk versus low risk malignancies (Table ) . A common theme of these classifiers is that the hallmark of the luminal A subtype is high expression of ER, an up‐regulated ER pathway, and low proliferation whereas the luminal B subtype expresses ER, cell‐cycle associated RNAs, receptor tyrosine kinase‐signaling associated genes such as HER2, and typically lacks PR expression . While triple negative (ER/PR/HER2 negative) tumors are frequently determined to be basal‐like tumors, triple negative tumors can be classified as other subtypes up to 25% of the time .…”