The screening of women with dense breasts is complicated by three issues:
- dense tissue can mask cancers and reduces the sensitivity of mammography,
- an increased risk of developing breast cancer, and
- an increased risk of developing more aggressive breast cancers.
Accurate and reproducible breast density measurements assist clinical decision-making regarding supplemental imaging and enable personalized screening.
VolparaDensity is a fully automated breast density assessment software that estimates the volume of fibroglandular (dense) tissue in the breast from digital mammograms. Independent researchers have published studies showing a strong association between the volumetric breast density, as assessed by Volpara, and breast cancer risk.
Independent research shows high correlation between VolparaDensity mammographic density and breast cancer risk
The first study provides a comprehensive comparison of six different methods of measuring mammographic density and their association with breast cancer risk, using digital images from 414 cases and 685 controls .
- Women in the highest breast density quintile (top 20%) had 8.26 times the risk of those in the lowest quintile (the 95% confidence range was 4.28-15.96), as measured by Volpara (after adjustments for age, BMI and reproductive factors).
- Volpara was better at identifying women at low risk than other methods.
- Of the six methods studied, the association of breast density with breast cancer risk was highest for Volpara and Cumulus (a semi-automated area-based method).
- Volpara and Cumulus were the only tools that produced breast density measures for all images in the study, with other methods failing to produce readings for up to 11% of the participants.
The next study supports the earlier findings from a large prospective cohort study by the Karolinska Institute in Sweden. This study comprised of 41,102 women from the KARMA (KARolinska MAmmography project for risk prediction of breast cancer) cohort, which follows women attending mammography screening or clinical mammography at four hospitals in Sweden. The performance of VolparaDensity was validated across multiple mammography vendor platforms, and volumetric breast density measurements were found to be significantly associated with both a genetic determinant of breast density and breast cancer risk (women in the highest quartile, i.e. top 25%, were 3-fold more likely to develop breast cancer compared to those in the lowest quartile) . The digital mammography was performed using five different models from three manufacturers (GE Medical Systems, Philips Healthcare and Sectra Imtec AB). Based on the results, the researchers concluded that automated measurement of volumetric mammographic density using VolparaDensity is a promising tool for widespread breast cancer risk assessment.
A third validation study was done in Korea and found that high volumetric breast density was significantly associated with the risk of breast cancer in postmenopausal Korean women. Furthermore, increased density in postmenopausal women was also associated with higher grade tumors, larger tumors, and lymph node involvement .
All three studies showed a strong correlation between Volpara’s breast density measurement and breast cancer risk, highlighting the importance of objective and accurate measurement of volumetric breast density. Additional studies and ongoing research is underway in the US, Canada, UK, Sweden, and Korea to investigate the utility of volumetric methods in screening settings including their contribution to the development of specific screening approaches tailored to a woman's risk.
 A. Eng, Z. Gallant, J. Shepherd, V. McCormack, J. Li, M. Dowsett, S. Vinnicombe, S. Allen & I dos-Santos-Silva, "Digital mammographic density and breast cancer risk: a case-control study of six alternative density assessment methods," Breast Cancer Research, 16:439 doi:10.1186/s13058-014-0439-1, 2014
 J. Brand, K. Czene, J. Shepherd, K. Leifland, B. Heddson, A. Sundbom, J. Li, K. Humphreys & P. Hall, "Automated measurement of volumetric mammographic density: a tool for widespread breast cancer risk assessment,” Cancer Epidemiology, Biomarkers & Prevention, DOI: 10.1158/1055-9965. EPI-13-1219
 I. H. Park, K. Ko, J. Joo, B. Park, S. Jung, S. Lee, Y. Kwon, H. Kang, E. S. Lee, K. S. Lee & J. Ro, "High Volumetric Breast Density Predicts Risk for Breast Cancer in Postmenopausal, but not Premenopausal, Korean Women," Ann Surg Oncol DOI 10.1245/s10434-014-3832-1