The “Master Driver” Genes
The central principle of the OncoAssure process is to identify a concise panel of upstream “master driver” genes which represent a reliable indicator of disease progression, rather than a long list of “passenger” genes. The two key components of the “master driver” genes are that they regulate the expression of other prognostic genes and they provide significant prognostic information beyond that provided by standard clinical and pathological information.
Once the “master driver” genes for predicting disease progression are identified, OncoAssure uses its tested and proven bioinformatic process to develop and manufacture highly sensitive and reproducible RT-qPCR-based in vitro diagnostic (IVD) assays.
Optimised and validated workflow
At OncoAssure we believe clinicians and patients benefit from easy access to fast and reliable diagnostic tests for timely clinical decisions. The OncoAssure IVDs are designed to be run at local hospital laboratories on standard RT-qPCR instruments with fully validated test reagents.
OncoMasTR is a decentralised gene expression profiling test to estimate risk of distant recurrence in hormone receptor positive, HER-2 negative early-stage breast cancer patients. OncoMasTR was acquired by Cepheid for use on their GeneXpert system and will be marketed under the name Xpert Insight Breast Cancer.
1.Lanigan F et al. FEBS J 2015; 282(18):3455-73. 2.Loughman T et al. Clin Chem 2022; 68(6):837-847. 3.Buus R et al. Clin Can Res. 2020; 26:623-31. 4.Lynch SM et al. Eur J Can. 2021; 152:78-79. 5.Filipits M et al. Clin Can Res. 2021; 27(21):5931-5938.
OncoAssure Prostate Cancer Test
Prostate cancer is the second most common cancer in men, the second leading cause of cancer death in men, and the fourth most prevalent cancer globally. Approximately 1 in 7 men will be diagnosed with prostate cancer during their lifetime. In Europe and the US combined approximately 600,000 men are diagnosed with prostate cancer annually, with nearly five million men living with prostate cancer.
As a result of increased awareness of prostate cancer, wide-spread PSA (prostate-specific antigen) and DRE (digital rectal exam) testing, the disease is generally detected at an early stage. The majority of patients have localised prostate cancer (cancer that has not spread to distant sites such as lymph nodes or bone) and can manage their disease through frequent monitoring known as active surveillance. However, some patients have aggressive prostate cancer which have the potential to spread to distant sites in the body and therefore require more aggressive treatment.
Accurately identifying patients with aggressive prostate cancer represents a major clinical unmet need and is crucially important for selecting the appropriate treatment options for men with prostate cancer. A prognostic test which accurately identifies patients with aggressive prostate cancers at initial diagnosis will help identify high-risk patients (approximately 20%) who will benefit from more aggressive treatment of their disease and give low-risk patients peace of mind that active surveillance is the correct option for them.
OncoAssure Prostate is a biopsy-based molecular test to identify patients with low-risk prostate cancer who can be safely managed with active surveillance, thus avoiding significant life-long side-effects associated with more aggressive treatment strategies. The OncoAssure Prostate test has been developed and optimised in a large, multi-centre cohort and clinically validated in two independent international cohorts.
1. Krzyzanowska et al. Eur Urol Focus 2023, In Press. 2. Krzyzanowska et al. J Clin Oncol 41, 2023 (suppl 6; abstr 374). Abbreviations: PCRC, Prostate Cancer Research Consortium: CLSI, Clinical and Laboratory Standards Institute; UPCA, Urology Prostate Cancer; AP, Adverse Pathology; BCR, Biochemical Recurrence
