Products
NovaGray tests
NovaGray has developed and commercializes the first tests to predict normal tissue tolerance to radiotherapy for patients with breast or prostate cancer.
First tests to predict tolerance to radiotherapy.
WHY TO DO A RADIOSENSITIVITY TEST?
The patient’s radiosensitivity level is an important knowledge that can contribute to:
- reassure the patient before radiotherapy initiation
- guide physicians in selecting the most appropriate treatment plan
- adapt the patient’s follow-up after radiotherapy
The experts of the REQUITE scientific consortium have proposed suggestions for adjusting the treatment plan by taking into account (i) the probability of tumor control, and (ii) the probability of normal tissue complications [1].
These suggestions include adapting the irradiation technique and volume, the total dose and dose per fraction, the number of sessions, the combination of systemic treatments and the involvement of exogenous factors aggravating side effects
When the risk of late complications is high, physicians may also propose an alternative treatment to radiotherapy if it shows equivalent efficacy [1].
How does the NovaGray test work?
The NovaGray test must be performed before starting radiation therapy and requires one simple blood sample.
The test does not delay treatment initiation.
The test can be directly requested by the patient or by the physician
NovaGray tests
NovaGray RILA 2 Prostate®
Intended use: The NovaGray RILA Prostate® test assesses the probability of developing grade ≥2 pelvic toxicity at month 24 after radiation therapy. The NovaGray RILA Prostate® test complies with the regulatory requirements of Directive 98/79/EC on in vitro diagnostic medical devices and obtained the CE marking in 2018 (test with irradiation) and in 2022 (test without irradiation).
Target population: The NovaGray RILA Prostate® test is intended for ≥60-year-old men with localized low- or intermediate-stage prostate cancer (T1-T2, Gleason score 6-7, and PSA <15 ng/ml) without metastatic disease and for whom radiation therapy is indicated.
Patients can contact their physician or the NovaGray team to validate their eligibility for the test.
NovaGray RILA 2 Breast®
Intended use: The NovaGray RILA Breast® test assesses the probability of developing grade ≥2 breast fibrosis at month 36 after radiation therapy.The NovaGray RILA Breast® test complies with the regulatory requirements of Directive 98/79/EC on in vitro diagnostic medical devices and obtained the CE marking in 2016 (test with irradiation) and in 2022 (test without irradiation).
Target population: The NovaGray RILA Breast® test is intended for >18-year-old women who require adjuvant breast radiotherapy after surgery (conservative treatment or mastectomy) for N+, N-RH+, RH-, HER2+, or HER2- breast cancer without metastatic disease.
Patients can contact their physician or the NovaGray team to validate their eligibility for the test.
References
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.
