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Screening for breast cancer in the Western countries currently focuses on mammography with types and target populations varying from one country to another. In France it is for women from 50 to 74 years old. The types of screening today have certain limitations however: limited benefit, imperfect sensitivity, over-diagnosis, irradiation and they start at age 50, whereas over 20% of cancers occur before 50.

MammoRisk® , a class I medical device, is a test for predicting breast cancer risk. It includes five factors: age, breast density quantified by a mammogram; the number of first degree relatives with breast cancer (mother, sister, daughter); antecedent or otherwise of breast biopsy and a polygenetic risk score, when available.

With the MammoRisk® test results, the doctor can propose customised monitoring in relation to the patient’s risk. MammoRisk® is based on measurement of risk in the general population using French (300,000 women) and American (1,000,000 women) data from organised screening in collaboration with several screening centres.

A questionnaire
clinical data

A mammogram
(breast density)

An optional saliva test
(polygenic score)

Report

You are a doctor and you want to offer a prevention consultation?

MammoRisk, a scoring tool:

The risk model MammoRisk® uses is based on the evaluation, based on a database of individuals monitored over time, of an individual’s risk in comparison to the fate of her “closest” neighbours.

The innovative, proprietary “Close Neighbours” method uses machine-learning algorithms to evaluate an individual’s risk of developing a serious pathology. This method seeks to evaluate, on a number of persons called neighbours (same characteristics: age, family background, etc.), how many of them are likely to develop an illness. With this approach an individual’s risks can be evaluated in comparison to their “closest” neighbours. This flexible method can be adapted to all databases and replaces the complex, opaque mathematical models used until now. This innovative approach to calculating risk has been patented. Applied to breast cancer, it has been validated with French and American data from organised screening, in collaboration with various screening centres.

MammoRisk is a test that integrates
the 3 pillars of breast cancer risk.

Breast density:

Women with significant breast density have a higher breast cancer risk: women with the highest density have 4 to 6 times more risk of breast cancer than women whose breasts are almost entirely made up of adipose tissue. Breast density decreases with age, but certain breast cancer risk factors are also associated with breast density: breast density is higher in women who have not had children, late pregnancy, high alcohol consumption or a significant body mass index (post-menopause).
DenSeeMammo is software developed by Predilife that permits automatic evaluation of breast density from a mammogram.

Boyd NF et al. Mammographic Density and the Risk and Detection of Breast Cancer. N Engl J Med 2007

Polygenetic Risk Score (PRS):

PRS is the result of a genetic test. The combination of several SNPs (Single Nucleotide Polymorphisms) gives a polygenetic risk score. Although the risk associated to an individual SNP is weak, combining several SNPs in a polygenetic risk score increases the strength of the association. PRS are statistically independent of established clinical risk factors.
The complementarity of SNPs for predicting breast cancer risk in relation to other breast cancer risk factors like breast density and reproductive history has now been shown. Combinations of risk models including traditional clinical variables + breast density + PRS can be used to estimate the population risk more accurately. This enables to refine and discriminate better between high and low risk groups.

Vachon CM, et al. The contributions of breast density and common genetic variation to breast cancer risk. J Natl Cancer Inst. 2015;107(5).
Shieh et Al. Breast Cancer Screening in the Precision Medicine Era: Risk-Based Screening in a Population-Based Trial
JNCI J Natl Cancer Inst (2017) 109(5) Yanes et Al. Clinical applications of polygenic breast cancer risk: a critical review and perspectives of an emerging field Breast Cancer Research (2020) 22:21

Clinical data questionnaire:

Family background
A family history of breast cancer is one of the major risk factors for breast cancer, especially if the breast cancer was diagnosed at an early age in family members. Almost 20 to 30% of breast cancers appear in women with a family history of breast cancer, that is, with several cases of breast cancer in the same family.
Campagnoli C et al. Breast cancer and hormone replacement therapy: putting the risk into perspective. Gynecol Endocrinol. 2001

Patient age
Breast cancer is the most frequently observed cancer among women in France, the European Union and the United States. The number of observed cases each year has tended to fall since 2005 and although this illness is still the major cause of death due to cancer among women in 2012, if detected at an early stage, it can be cured in 9 out of 10 cases.
Source : www.e-cancer.fr (Institut National Du Cancer) ; IARC (International Agency Research on Cancer) ; Globocan 2018

Biopsy history
A personal history of breast biopsy is associated with an increased risk of breast cancer. But in fact, the biopsy is not a risk factor itself, but rather a marker of risk. This examination can be performed if there is a suspected anomaly or lesion in the breast.
Cuzick J et al.Epidemiology of breast cancer–selected highlights.Breast. 2003

What result?

At the end of the test, MammoRisk provides a clear, accurate report with an estimate of the absolute risk of breast cancer over 5 years, that is, the likelihood of developing invasive cancer within 5 years.
On the basis of that estimate, the doctor can establish a customised monitoring programme with the patient.

2 complementary tools

You may decide you need the MammoRisk software and if you are a radiologist, associate it with DenSeeMammo.

Intended for radiologists, DenSeeMammo is an innovative class I medical device also developed by Predilife. It provides a standardised, automatic evaluation of breast density from mammogram images.

By enabling the DenSeeMammo software to be associated with the MammoRisk test, Predilife offers a comprehensive solution for reliably predicting breast cancer risk so that you can offer the most appropriate customised monitoring.

MammoRisk® and DenSeeMammo® are class I medical devices manufactured by Predilife. These medical devices are regulated health products bearing a CE mark. Ask your doctor for advice.

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The information on this page is only intended for users in countries that recognise EC-approved medical devices.
In accordance with the French Law No. 2011-2012 of 29/12/2011, this page is exclusively dedicated to healthcare professionals, researchers and manufacturers, not for the general public.
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