With the current approach, decisions on cancer treatment are made by the oncologists and can include surgery, chemotherapy, hormonal treatment, targeted drugs when available, immune therapy and radiation therapy. However, currently, clinical decision-making for radiation therapy is qualitative, population-based, and does not take into account differences in terms of tolerance to treatment in individual patients.
The ability to stratify patients using a set of biomarkers, which predict toxicity risk would serve as a highly valuable tool for precision medicine and personalized RT. NovaGray Breast®/Prostate® is the first biological test that can effectively achieve this, stratifying cancer patients according to their likelihood to develop long term side-effects as a consequence of RT regimens. The introduction of NovaGray tests in the clinical practice would represent a major step forward, providing great support to oncologists in improving treatments according to the individual biological specificities of patients, increasing treatment efficiency, efficacy and safety, and reducing costs. More specifically, several strategies have already been presented to improve cancer treatment according to the risk of toxicity. For a patient at low risk of developing radiation-associated toxicity, use of a hypo fractionated protocol (higher doses in shorter period of time) could be proposed leading to treatment time reduction and a cost–utility advantage. Conversely, for patients predicted to be at high risk for toxicity, either a more conformal treatment or a new technique of RT (e.g. photon therapy which is more effective, has less side effects, but is much more expensive), or a multidisciplinary approach employing surgery could be included in the treatment.
To sum-up, it is of utmost importance to improve and personalise RT treatments in order to achieve better outcomes and reduce the side-effects of RT. Several treatments adaptations have been suggested to achieve this but there are currently no tests that can effectively stratify patients. NovaGray has developed a technology to fill this gap.
Expected results until the end of the project:
To get reimbursement for NovaGray Breast®/Prostate®, we expect, through trials with 900 patients, to demonstrate the clinical and cost utility of NovaGray tests - i.e. demonstrate that cancer treatment modifications based on RT patient stratification lightens/avoid the development of RT late side-effects and improves the overall outcome of RT efficacy. This will ensure the large uptake of the biological tests. Furthermore, we expect to secure commercial partnerships with large biomedical labs to scale-up the business.
