PRODUCTS
NOVAGRAY TESTS
NovaGray has developed and commercialized the first radiotherapy tolerance test for patients treated for breast and prostate cancer.
Performed before the start of radiotherapy with a simple blood draw, this test assesses the patient’s individual radiosensitivity, reassuring the majority of patients that they will not develop late complications.
First tests to predict tolerance to radiotherapy.
WHY HAVE A RADIOSENSITIVITY TEST?
Knowing a patient’s individual radiosensitivity is important information that can help:
- Reassure the patient in preparation for radiotherapy
- Guide physicians in choosing the most appropriate treatment plan
- Adapt patient follow-up after radiotherapy
Suggestions for therapeutic modifications based on (i) the probability of tumor control and (ii) the probability of normal tissue complications have been put forward by experts from the REQUITE scientific consortium [1].
These suggestions include adapting the technique and volume of irradiation, the total and the dose per fraction, the number of fractions, the combination of systemic treatments and the involvement of programs to stop exogenous factors aggravating side effects.
Where there is a high risk of late complications, physicians may also opt for an alternative therapy to radiotherapy, where the latter has demonstrated equivalent efficacy to radiotherapy [1].
HOW IT WORKS?
The NovaGray test must be performed before the start of radiotherapy, and requires a simple blood sample.
The test does not delay treatment.
The request for a test can be made directly by the patient or the physician.NOVAGRAY TESTS
NovaGray RILA Prostate®
Intended use: The NovaGray RILA Prostate® test assesses the risk of developing grade 2+ pelvic toxicity at 24 months after radiotherapy. NovaGray RILA Prostate® complies with the regulatory requirements of Directive 98/79 on in vitro diagnostic medical devices, and has been CE marked since 2022.
Target population: The NovaGray RILA Prostate® test is intended for men with localized or locally advanced non-metastatic prostate cancer for whom radiotherapy is indicated.
Patients can contact their physician or the NovaGray team to confirm their eligibility for the test.
NovaGray RILA Breast®
Intended use: The NovaGray RILA Breast® test assesses the risk of developing grade 2+ breast fibrosis 36 months after radiotherapy. NovaGray RILA Breast® complies with the regulatory requirements of Directive 98/79 on in vitro diagnostic medical devices, and has been CE marked since 2022.
Target population: The NovaGray RILA Breast® test is intended for women over 18 who require adjuvant breast radiotherapy following surgery (conservative treatment or mastectomy), N+ or N-RH+ or RH-, HER2+ or HER2- and without metastatic disease.
Patients can contact their physician or the NovaGray team to confirm their eligibility for the test.
SCIENTIFIC REFERENCES AND PUBLICATIONS
1. Azria D, Lapierre A, Gourgou S, et al. Data-based radiation oncology: design of clinical trials in the toxicity biomarkers era. Front Oncol 2017 ; 7 : 83.
2. Ozsahin M, Ozsahin H, Shi Y, Larsson B, Wurgler FE, Crompton NE, et al. Rapid assay of intrinsic radiosensitivity based on apoptosis in human CD4 and CD8 T-lymphocytes. Int J Radiat Oncol Biol Phys 1997;38:429-40.
3. Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, et al. CD4 and CD8 T-lymphocyte apoptosis can predict radiation- induced late toxicity: a prospective study in 399 patients. Clin Cancer Res 2005;11:7426-33.
4. Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, et al. Radiation-induced CD8 T-lymphocyte apoptosis as a predic- tor of breast fibrosis after radiotherapy: results of the prospective multicenter French trial. EBioMedicine 2015;2:1965-73.
5. ESTRO 2019, Oral communication.