TECHNOLOGY
What technology are NovaGray tests based on?
The NovaGray technology is based on more than 20 years of research on the Radiation-Induced Lymphocyte Apoptosis (RILA) assay.
In the classical protocol (RILA test), an aliquot of the blood sample is irradiated (dose of 8Gy) and then the percentage of CD8-positive T-lymphocyte death is quantified. This rate is negatively correlated with the probability of developing late complications.
To make this technology accessible to all patients, NovaGray team improved the RILA test by developing a new method (RILA test 2) that does not require irradiation.
20 years of R&D.
Highest level of clinical evidence.
1997
Discovery and first validation of the RILA assay
Prof. Nigel Crompton (Paul Scherer Institute, Switzerland) and Prof Mahmut Ozsahin (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland), then continued by Prof David Azria (Montpellier Cancer Institute, France), co-founder of NovaGray.
2005
Single-center prospective validation
First prospective monocentric validation study at the Centre Hospitalier Universitaire Vaudois in Lausanne on 399 patients treated by radiation therapy (different tumor locations, particularly, ear-nose-throat, head and neck, cervix, breast, and prostate cancer).
2015
Prospective French multicenter validation study of the RILA test (Breast)
Multicenter prospective validation study in 502 patients with breast cancer enrolled in 10 cancer centers in France. This study started in 2005 and the results were published in 2015.
NovaGray establishment
NovaGray objective is to develop at the industrial scale the RILA test and transfer it from research to routine clinical use.
2016
NovaGray RILA Breast® test CE Marking
NovaGray obtains the CE marking for the RILA test for breast cancer.
2018
NovaGray ISO 13485 certification
Research and development of a new RILA test, without irradiation
To make the RILA test available for routine testing, NovaGray developed a new test that does not require irradiation of the blood sample. This method is called RILA 2.
Patent registration
Several patents have been filed to protect NovaGray innovations.
2019
Prospective French multicenter validation of the RILA test (Prostate)
Prospective multicenter validation study of the RILA test in 360 patients with prostate cancer enrolled in 10 centers in France. This study started in 2005 and results were presented at the annual congress of the European Society of Radiation Oncology (ESTRO) in 2019.
NovaGray RILA Prostate® test CE Marking
NovaGray obtains the CE marking for the RILA test for prostate cancer.
2020
Prospective European multicenter validation study of the RILA tests (Breast, Prostate)
The RILA test has been validated in a prospective multicenter study in three European countries (France, Germany, England), coordinated by the REQUITE consortium and funded by an European Commission Seventh Framework Program grant. More than 4000 patients were enrolled in this study, including 2900 patients treated for breast and prostate cancer. Results confirmed RILA predictive value for late toxicity occurrence.
2021
Equivalence between the RILA and RILA 2 tests
The statistical equivalence between the RILA and RILA 2 (without irradiation) tests was confirmed using more than 130 blood samples.
2022
CE marking of the RILA 2 tests without irradiation (Breast, Prostate)
NovaGray obtained the CE Marking for the RILA 2 tests for breast and prostate cancer.
Utilization in clinical routine
The NovaGray technology is transferred to medical laboratories that perform the RILA 2 test. The NovaGray RILA 2 Breast® and NovaGray RILA 2 Prostate® tests are now available for clinical routine testing in the entire France.
New tests under development
NovaGray is developing a new generation of « multi-parametric » tests that combine the patient’s RILA test results and clinical data.
These tests are currently undergoing clinical validation, and will allow the continuous improvement of the RILA test performance.
Level I of clinical evidence
To date, the RILA test is the only technique that reached level I clinical evidence [1], which corresponds to the highest level of clinical validation according to the REMARK criteria.
The REMARK criteria have been published by the American Society of Clinical Oncology (ASCO) and are used to assess the quality of the clinical validation studies to evaluate prognostic and predictive biomarkers [2, 3, 4].
NovaGray tests are recommended by the French Society of Radiation Oncology (SFRO) [5].
Ongoing clinical studies
NovaGray is participating in interventional studies and in the validation study of its test for a new clinical indication.
References
1. Brengues M, Lapierre A, Bourgier C, Pèlegrin A, Ozsahin M, Azria D. T lymphocytes to predict radiation-induced late effects in normal tissues. Expert Rev Mol Diagn 2017 ; 17 : 119-27.
2. McShane LM, Altman DG, Sauerbrei W, et al. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005 ; 97 : 1180-4.
3. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 2009 ; 101 : 1446-52.
4. McShane LM, Altman DG, Sauerbrei W, et al. REporting recommendations for tumor MARKer prognostic studies (REMARK). Breast Cancer Res Treat 2006 ; 100 : 229-35.
5. Lapierre et al. Cancer Radiotherapie 2022.
