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The first radiosensitivity test for Breast Cancer : the NovaGray Breast® test

NovaGray has developed the first radiosensitivity test for normal tissue for breast cancer  treatment.
It the only test that has been validated prospectively on a large scale. This patented test is based on the study of the in vitro radio-induced lymphocyte apoptosis level derived from a blood test.
Researches started in 1997 with preclinical tests, retrospective clinical studies and a prospective monocenter clinical study. Final results have recently been obtained from a prospective multicenter trial in France in 2015 (PHRC 2005) validating the preliminary results.
The results from the biological test are included in a patented predictive nomogram including other clinical parameters found independent factors of late breast fibrosis. The combination of both steps allow an excellent negative predictive value (more than 90%).
The NovaGray Breast® test meets all regulatory requirements of the 98/79 directive pertaining to the in vitro diagnostic medical devices. It has also been stamped with the CE marking.
The results come out within a week and therefore do not delay radiotherapy initiation.

Tests for prostate and lung cancers are underway. 

Pr. Azria, the physician who initiated the clinical validation of the test, was awarded at the ASTRO Annual Meeting (American Society for Radiation Oncology) with the Translational Science Abstract Award in October 2015.

Taking the NovaGray Breast® test

The results from the NovaGray Breast® test will allow you to discuss the following subjects with your patient:

  • the irradiation volume

  • the total dose and the dose fractioning

  • the possibility of breast reconstruction surgery and its esthetics implication

  • the combination of systemic treatments

  • the consequences of exogenous factors halt programs which worsen side effects

  • suggest tailored irradiation techniques, in particular the intensity modulation

When should the test be taken ?

The test must be taken before the start of the radiation therapy. The request for the test can be initiated by either yourself or your patient.

Order a kit
from NovaGray

Send the kit back 
with the blood sample

NovaGray analyses
the blood sample

Results are sent
to the physician

Who take the NovaGray Breast® test ?

The NovaGray Breast® test is targeted to women who will undergo radiation therapy as part of their treatment for breast cancer.

The tests developed by NovaGray

NovaGray Breast®

NovaGray Breast® est un test prédictif de radiosensibilité des tissus sains a une Valeur Prédictive Négative supérieure à 90%, ce qui permet de conclure à l’absence de risque de séquelles tardives sévères comparée à la population générale avec plus de 90% d’exactitude.
 
NovaGray Breast® est conforme aux exigences réglementaires de la directive 98/79 relative aux dispositifs médicaux de diagnostic in vitro et dispose du marquage CE.

Scientific Publications

Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.
Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Bourgier C, Rivera S, Noël G, Clippe S, Mornex F, Hennequin C, Kramar A, Gourgou S, Pèlegrin A, Fenoglietto P, Ozsahin EM.
EBioMedicine. 2015 Oct 25;2(12):1965-73. doi: 10.1016/j.ebiom.2015.10.024. eCollection 2015 Dec.

Concurrent or sequential letrozole with adjuvant breast radiotherapy: final results of the CO-HO-RT phase II randomized trial†.
Bourgier C, Kerns S, Gourgou S, Lemanski C, Gutowski M, Fenoglietto P, Romieu G, Crompton N, Lacombe J, Pèlegrin A, Ozsahin M, Rosenstein B, Azria D.
Ann Oncol. 2016 Mar;27(3):474-80. doi: 10.1093/annonc/mdv602. Epub 2015 Dec 17.

Radiation-induced sequelae measured by lymphocyte apoptosis: in regard to Foro et al.
Ozsahin M, Azria D.
Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):470. doi: 10.1016/j.ijrobp.2014.06.003. No abstract available.
 
[Intrinsic radiosensitivity: predictive assays that will change daily practice].
Lacombe J, Riou O, Solassol J, Mangé A, Bourgier C, Fenoglietto P, Pèlegrin A, Ozsahin M, Azria D.
Cancer Radiother. 2013 Oct;17(5-6):337-43. doi: 10.1016/j.canrad.2013.07.137. Epub 2013 Aug 30. Review. French.

[Identification of predictive biomarkers to radiotherapy outcome through proteomics approaches].
Lacombe J, Mange A, Azria D, Solassol J.
Cancer Radiother. 2013 Feb;17(1):62-9; quiz 70, 72. doi: 10.1016/j.canrad.2012.11.003. Epub 2012 Dec 31. Review. French.

[Radiosensitivity assays of normal tissues].
Lacombe J, Solassol J, Pouget JP, Coelho M, Azria D.
Bull Cancer. 2011 Dec;98(12):1469-75. doi: 10.1684/bdc.2011.1497. French.

 [Interest of blood markers in predicting radiation-induced toxicity].
Lacombe J, Solassol J, Coelho M, Ozsahin M, Azria D.
Cancer Radiother. 2011 Aug;15(5):390-3. doi: 10.1016/j.canrad.2011.02.006. Epub 2011 Jun 14. Review. French.

Identifying patients at risk for late radiation-induced toxicity.
Azria D, Betz M, Bourgier C, Jeanneret Sozzi W, Ozsahin M.
Crit Rev Oncol Hematol. 2012 Dec;84 Suppl 1:e35-41. doi: 10.1016/j.critrevonc.2010.08.003. Epub 2010 Sep 24. Review.

A large-scale candidate gene approach identifies SNPs in SOD2 and IL13 as predictive markers of response to preoperative chemoradiation in rectal cancer.
Ho-Pun-Cheung A, Assenat E, Bascoul-Mollevi C, Bibeau F, Boissière-Michot F, Thezenas S, Cellier D, Azria D, Rouanet P, Senesse P, Ychou M, Lopez-Crapez E.
Pharmacogenomics J. 2011 Dec;11(6):437-43. doi: 10.1038/tpj.2010.62. Epub 2010 Jul 20.

[Factors of late radiosensitivity of normal tissues].
Azria D, Pointreau Y, Toledano A, Ozsahin M.
Cancer Radiother. 2010 Jul;14(4-5):250-4. doi: 10.1016/j.canrad.2010.04.002. Epub 2010 Jul 2. French.

Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial.
Azria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M.
Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.

Radiation-induced sequelae measured by means of lymphocyte apoptosis: importance of certain single nucleotide polymorphisms: in regard to Schnarr et al. (Int J Radiat Oncol Biol Phys 2009).
Azria D, Ozsahin M, Rosenstein B.
Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1275; author reply 1275-6. doi: 10.1016/j.ijrobp.2009.06.084. No abstract available.

Individual radiosensitivity measured with lymphocytes: late effects are the key point: in regard to borgmann et Al. (Int j radiat oncol biol phys 2008;71:256-264).
Azria D, Ozsahin M.
Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):654; author reply 654-5. doi: 10.1016/j.ijrobp.2009.01.071. Epub 2009 Mar 26. No abstract available.

[Impact of radiotherapy modalities on local control and survival in adjuvant breast cancer treatment].
Azria D, Hennequin C.
Cancer Radiother. 2009 Sep;13(5):434-45. doi: 10.1016/j.canrad.2009.01.006. Epub 2009 Mar 19. French.

Single nucleotide polymorphisms, apoptosis, and the development of severe late adverse effects after radiotherapy.
Azria D, Ozsahin M, Kramar A, Peters S, Atencio DP, Crompton NE, Mornex F, Pèlegrin A, Dubois JB, Mirimanoff RO, Rosenstein BS.
Clin Cancer Res. 2008 Oct 1;14(19):6284-8. doi: 10.1158/1078-0432.CCR-08-0700.

[Radiation-induced sequelae: toward an individual profile].
Azria D, Belkacemi Y, Lagrange JL, Chapet O, Mornex F, Maingon P, Hennequin C, Rosenstein B, Ozsahin M.
Cancer Radiother. 2008 Nov;12(6-7):619-24. doi: 10.1016/j.canrad.2008.07.009. Epub 2008 Aug 30. French.

Radiation-induced side effects with or without systemic therapies: prime time for prediction of individual radiosensitivity.
Azria D, Rosenstein BS, Ozsahin M.
Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1293-4. doi: 10.1016/j.ijrobp.2008.03.057. No abstract available.

Metabolic functional imaging for tumor radiosensitivity monitoring.
Belkacémi Y, Tsoutsou P, Magné N, Castadot P, Azria D.
Crit Rev Oncol Hematol. 2007 Jun;62(3):227-39. Epub 2007 Jan 22. Review.


The epidermal growth factor receptor (EGFR) in head and neck cancer: its role and treatment implications.
Zimmermann M, Zouhair A, Azria D, Ozsahin M.
Radiat Oncol. 2006 May 2;1:11. Review.

CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients.
Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO,Azria D.
Clin Cancer Res. 2005 Oct 15;11(20):7426-33.

Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients.
Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M.
Br J Cancer. 2004 Oct 4;91(7):1251-60.

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