AI-Based Breast Cancer Risk Assessment Tool Enters Clinical Validation Study — Implications for Australian Genetic Screening Pathways

References

1. 1.AstraZeneca. (2024). Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST) [Clinical trial registration NCT07070128]. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07070128
2. 2.Australian Government Department of Health. (2023). Medicare Benefits Schedule - Genetic Counselling and Testing. Medicare Benefits Schedule. http://www.mbsonline.gov.au
3. 3.Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., ... & de Vet, H. C. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527. https://doi.org/10.1136/bmj.h5527
4. 4.Forrest, L. E., Burke, J., Bacic, S., & Amor, D. J. (2008). Increased genetic counseling support improves communication of genetic information in families. Genetics in Medicine, 10(3), 167-172. https://doi.org/10.1097/GIM.0b013e31816b64c6
5. 5.Knoppers, B. M., Zawati, M. H., & Senecal, K. (2015). Return of genetic testing results in the era of whole-genome sequencing. Nature Reviews Genetics, 16(9), 553-559. https://doi.org/10.1038/nrg3960
6. 6.Kuchenbaecker, K. B., Hopper, J. L., Barnes, D. R., Phillips, K. A., Mooij, T. M., Roos-Blom, M. J., ... & Olsson, H. (2017). Risks of breast, ovarian, and contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. JAMA, 317(23), 2402-2416. https://doi.org/10.1001/jama.2017.7112
7. 7.Manchanda, R., Burnell, M., Gaba, F., Desai, R., Wardle, J., Gessler, S., ... & Jacobs, I. (2018). Cost-effectiveness of population screening for BRCA mutations in Ashkenazi Jewish women compared with family history-based testing. Journal of the National Cancer Institute, 110(5), 540-541. https://doi.org/10.1093/jnci/djx01
8. 8.Rutjes, A. W., Reitsma, J. B., Di Nisio, M., Smidt, N., van Rijn, J. C., & Bossuyt, P. M. (2006). Evidence of bias and variation in diagnostic accuracy studies. CMAJ, 174(4), 469-476. https://doi.org/10.1503/cmaj.050090
9. 9.Schwartz, M. D., Valdimarsdottir, H. B., Peshkin, B. N., Mandelblatt, J. S., Nusbaum, R., Huang, A. T., ... & King, L. (2014). Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers. Journal of Clinical Oncology, 32(36), 4113-4120. https://doi.org/10.1200/JCO.2013.51.1079
10. 10.Therapeutic Goods Administration. (2023). Software as Medical Device: Guidance for Industry. TGA Guidelines. https://www.tga.gov.au/resources/resource/guidance/software-medical-device-guidance-industry