– PREEMPT CRC is a large, representative registrational study for the early detection of colorectal cancer
– Findings presented at the Western Colorectal Cancer Consortium Conference
SOUTH SAN FRANCISCO, March 6, 2023 — Today Freenome, a privately held biotech company, presents a subject population analysis from PREEMPT CRC, a study for the detection of colorectal cancer (CRC) at the Western Colorectal Cancer Consortium Conference in Portland, Oregon.
According to the American Cancer Society, colorectal cancer is the second-leading cause of cancer-related death. Despite evidence that CRC screening reduces cancer incidence and mortality, screening rates continue to remain below recommended guidelines.
Freenome is in the final stages of development of its blood-based screening test for colorectal cancer. The test uses Freenome’s multiomics platform, which combines tumor and non-tumor signals with machine learning to detect cancer in the earliest, most treatable stages using a standard blood draw. The test is intended to offer an accessible and convenient option for CRC screening.
PREEMPT CRC is the largest prospective study for CRC using a blood-based screening test in the average-risk population and is Freenome’s clinical validation study for the use of its test.
The study’s focus was to enroll subjects that reflected the demographics of the intended use population for a colorectal cancer screening test: average-risk adults between the ages of 45 and 85 across urban and rural communities in the United States. The study enrolled subjects between May 2020 and March 2022. Several mitigations for the impact of COVID-19 were developed and incorporated into overall study plans.
To ensure representation, Freenome integrated forward-thinking enrollment strategies into its clinical study design. The company offered options of virtual enrollment, electronic consenting and mobile phlebotomy that enabled home blood draws for participants who were not geographically close or able to visit a hospital or other study site.
“Our tests are designed for everyone, which means our clinical studies need to demonstrate that representation,” said Lance Baldo, M.D. and chief medical officer for Freenome. “Screening saves lives, and our goal is to make screening for CRC easier and more convenient for everyone.”
Analysis of results demonstrate enrollment strategies were effective in recruiting an intended-use population. For example, of the study’s participants, 25% enrolled virtually and 7% used the mobile phlebotomy team. Additionally, racial diversity was above historical clinical study participation[1] with approximately 11% Black, 11% Hispanic or Latino and 7% Asian participants.
“From the onset, we wanted this study to be representative of the people of the United States. Making participation convenient was key to drive enrollment, especially during a pandemic. The results of our efforts show it’s possible to have meaningful diversity in clinical trials,” said Aasma Shaukat, M.D., study co-lead, professor of medicine and director of outcomes research for the Division of Gastroenterology and Hepatology at NYU Langone Health.
For more information about PREEMPT CRC, visit Freenome’s clinical studies webpage.
[1] The Society for Women’s Health Research United States Food and Drug Administration Office of Women’s Health. Dialogues on diversifying clinical trials; 2011.