Development of Cell-Free Nucleic Acid-Based Tests for Detection of invasive breast cancer: The STRIVE Study

Mammography (digital or tomosynthesis) is the cornerstone of screening for breast cancer, but new approaches are needed to further reduce the rate of late stage cancer diagnosed and more effectively identify women in need of additional testing and diagnostic biopsy. Circulating cell-free nucleic acids (cfNAs) shed from tumors can be isolated from the peripheral blood and analyzed with ultra-deep and broad sequencing of cancer-associated genes1.

GRAIL, Inc. (www.grail.com) aims to develop blood cfNA screening tests capable of detecting many cancer types and providing information on the tissue of origin. Such tests could be used in concert with established risk factors and/or radiographic features to improve early cancer detection. Development and validation of these tests and related algorithms will require large, well-annotated prospective cohorts of asymptomatic participants. The STRIVE Study is the first of several planned prospective cohorts to be assembled for this product development.