Saint Louis University Journal of Health Law & Policy


Megan K. Hart

Document Type

Student Comment


It is estimated that 268,600 women were diagnosed with breast cancer in 2019 alone, and as many as 26,860 of these women could have developed breast cancer due to a genetic disposition.[1] While over one million women have undergone genetic testing to identify variations in the BRCA1 and BRCA2 genes, the test results are often ambiguous due to identified variations for which the breast cancer development risk is unknown.[2] A new technology known as CRISPR has the potential to change this state of uncertainty due to its capability to identify thousands of BRCA1 and 2 gene variations and accurately predict the associated breast cancer development risk.[3] However, access to this innovative technology for the accurate classification of breast cancer predictors has been impeded by the emergence of proprietary rights over breast cancer predictors and the inconsistent regulation of genetic testing by the Food and Drug Administration. This article proposes a single regulatory pathway for all genetic tests that requires clinical validity for approval, allowing the use of technology such as CRISPR to supplement clinical patient data with accurate laboratory data. This proposal provides incentives for companies to enter the genetic testing market, making breast cancer predictors available to the women who need them.

[1]. Breast Cancer Facts & Figures 2019-2020, Am. Cancer Soc’y (2019), https://www.can cer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-fig ures/breast-cancer-facts-and-figures-2019-2020.pdf; Tamsen Valoir, Breast Cancer, Politics, and Patents, 44 AIPLA Q. J. 63, 73 (2016).

[2]. Jay Shendure et al., What CRISPR Genome Editing Means for BRCA Breast Cancer Testing, Inverse (Oct. 1, 2018), https://www.inverse.com/article/49465-what-crispr-genome-edit ing-means-for-breast-cancer-research.

[3]. Sarah Zhang, With CRISPR, Scientists Engineered Nearly 4,000 Mutations of a Breast-Cancer Gene, The Atlantic (Sep. 12, 2018), https://www.theatlantic.com/science/archive/2018 /09/4000-brca1-variants/569827/.