New in vitro diagnostics medical devices are essential in oncology to improve early detection, diagnosis, and treatment of cancer, ultimately leading to better patient outcomes. Finding biomarkers that are clinically relevant and effective in a real-world setting is a challenging process that requires rigorous testing and validation. At Ophiomics we developed a unique approach to biomarker discovery centred around addressing strong clinical questions and minimising technical, clinical, and commercial uncertainties, enabling us to maximize the chances of bringing impactful products to market and positively impacting patients’ lives. We conceptualise our approach in three stages, as illustrated below.
Novel solutions for unmet clinical needs
At Ophiomics Discoveries, we validate and refine clinical questions raised by clinicians and patients, while carefully assessing their economic viability. We discover feasible biomarkers by harnessing data-mining to analyse large volumes of omics data, including fragmented nuclei acids from liquid biopsies or FFPE tissues. Our output is a decision algorithm with well-defined predictive variables paired with a laboratory assay design, and respective proof of concept results.
Transforming discoveries into market-ready IVD products
At Ophiomics Develop, we use a standardised process to transform proof of concept-level essays into fully industrialised and market-ready products. Product prototypes are developed in our ISO 13485 – certified pilot manufacturing facility, supported by our R&D laboratory in clinical validation studies. We combine the technical platforms for FFPE and liquid biopsies with a deep understanding of the regulatory framework of IVD medical devices and decision algorithms.
Bringing meaningful products to market
At Ophiomics go-to-market, we conduct market studies and devise strategies for early clinical prototyping of our products. We include clinical studies and limited clinical use of the products from an early stage of the process, as we firmly believe that early commercial validation is critical for the success of our products.
|Liver cancer patient stratification for transplantation||FFPE||Q3 2023:
3+ validation cohorts completed
|Diagnosis and prognosis of Barrett's Esophagus||FFPE||Q4 2023:
2+ validation cohorts completed
|Liquid biopsy for ealy liver cancer detection in cirrhotic patients||Blood|| Q1 2024
1+ validation cohort completed