WHAT IS THE TECHNOLOGY BEHIND THE NOVAGRAY TESTS?
NovaGray technology is based on over 20 years of research on the RILA test, which stands for “Radio Induced Lymphocyte Apoptosis”.
The historical protocol of the RILA test involves irradiating a portion of the blood sample at 8Gy and measuring the rate of T-CD8 lymphocyte apoptosis following this irradiation. There is an inverse correlation between the rate of lymphocyte apoptosis and the probability of developing late complications.
To make this technology available to as many patients as possible, NovaGray teams have improved the RILA test and developed a new testing method that no longer requires irradiation of the blood sample.
Highest level of clinical evidence.
Discovery and initial validation of the RILA test
Initiation of work on the RILA test by Prof. Nigel Crompton (Paul Scherer Institute, Switzerland) and Prof. Mahmut Ozsahin (CHUV, Lausanne), then continued by Prof. David Azria (Montpellier Cancer Institute, France), co-founder of NovaGray.
Single-center prospective validation
Single-center prospective validation at the Vaudois University Hospital (CHUV) in Lausanne on 399 patients treated with irradiation in various tumor locations including the ENT sphere, cervix, breast and prostate.
French multicenter prospective validation of the RILA (Breast)
Prospective multicenter validation on 502 breast cancer patients enrolled in 10 centers in France. This study began in 2005 and the results were published in 2015.
NovaGray aims to industrialize the RILA technique and transfer it from research to routine clinical use.
CE-marked NovaGray RILA Legacy Breast® (with irradiation)
NovaGray obtains CE mark for its RILA test in the breast cancer indication.
ISO 13485 certification for NovaGray
Research and development of new test, without irradiation
To make the RILA test available on a routine clinical use, NovaGray is developing a new test method that no longer requires irradiation of the blood sample.
NovaGray files several patents to protect its innovations.
Prospective French multicenter validation of RILA (Prostate)
Prospective multicenter validation of the RILA test in prostate cancer on 360 patients enrolled in 10 centers in France. This study began in 2005 and its results were presented at the European Society of Radiotherapy (ESTRO) congress in 2019.
CE-marked NovaGray RILA Legacy Prostate® (with irradiation)
NovaGray obtains CE mark for RILA test in the prostate cancer indication.
Prospective European multicenter validation of RILA test (Breast, Prostate)
Validation in a prospective multicenter European study (France, Germany, UK). This study was coordinated by the REQUITE consortium and funded by an FP7 grant. Over 4,000 patients were enrolled, including 2,900 with breast and prostate cancer. The results confirm the predictive value of RILA in the onset of late toxicities.
Equivalence between RILA with irradiation and RILA without irradiation
Statistical equivalence between RILA with irradiation and RILA without irradiation on over 500 samples.
CE marking for RILA test without irradiation (Breast, Prostate)
NovaGray obtains CE mark for its irradiation-free RILA test in breast and prostate cancer indications.
Production in clinical routine
NovaGray technology transferred to biomedical laboratories. NovaGray RILA Breast® and NovaGray RILA Prostate® tests are now available for routine clinical use in Europe.
NEW TESTS UNDER DEVELOPMENT
NovaGray is developing a new generation of “multi-parametric” tests. These tests combine the result of the RILA test with clinico-biological data of the patient.
Currently undergoing clinical validation, these tests will enable NovaGray to continually improve the performance of the RILA test.
LEVEL I OF CLINICAL EVIDENCE
To date, the RILA test is the only technology to have achieved Level I clinical evidence , which corresponds to the highest level of clinical validation according to the REMARK guidelines.
Published by the American Society of Clinical Oncology (ASCO), these guidelines assess the clinical validation of prognostic and predictive biomarkers [2,3,4].
NovaGray tests are also recommended by the French Society of Radiation Oncology .
SCIENTIFIC REFERENCES AND PUBLICATIONS
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.