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Freenome Announces Encouraging Performance Data for Its Multiomics Blood Test to Detect Early-Stage Colorectal Cancer in a Prospective, Multi-Center Clinical Study
[January 23, 2020]

Freenome Announces Encouraging Performance Data for Its Multiomics Blood Test to Detect Early-Stage Colorectal Cancer in a Prospective, Multi-Center Clinical Study


Freenome, a privately-held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection through a routine blood draw, is presenting data from their prospective, multi-center clinical study AI-EMERGE®. The colorectal cancer (CRC) study will be featured at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium (ASCO GI) on Saturday, January 25th in San Francisco. "We're delighted to present results from the first prospective clinical study with our multiomics blood test that achieved high sensitivity and specificity in early-stage CRC," said Gabriel Otte, Chief Executive Officer of Freenome. "This represents a significant step forward in our efforts to bring an effective early detection test to as many people as possible."

Freenome's poster, Blood-Based Detection of Early-Stage Colorectal Cancer Using Multiomics and Machine Learning, highlights the performance of their multiomics blood test, which combines tumor- and non-tumor-derived (such as immune) signals from cell-free DNA (cfDNA), epigenetic, and protein biomarkers into a machine learning-based classifier, to detect early-stage CRC. This study, which included average-risk screening and case-control subjects (n=574) and an analyte training set (n=17) drawn from a statistically-driven subset of AI-EMERGE®, demonstrated a sensitivity of 94% and specificity of 94% for early-stage (I/II) colorectal adenocarcinoma. "The current study shows exciting multiomics data demonstrating high sensitivity and specificity for detecting early-stage CRC," said Aasma Shaukat, MD, MPH, GI Section Chief at Minneapolis VAHCS and Professor of Medicine, University of Minnesota. "Early detection is key to improving survival and these results give us hope that in the future we may have a highly sensitive and specific blood test to screen patients for early disease." The Company expects to validate these results in a prospective, multi-center registrational study that will begin enrollment this year.

Freenome's multiomics blood test sensitivity and specificity by early (I/II) and late (III/IV) stage CRC





 

Sensitivity

Specificity

Early (Stage I/II)

Late (Stage III/IV)

94%

94%

91%

 

Freenome's multiomics blood test was also compared to a leading fecal immunochemical test (FIT). Subjects enrolled in the study were asked to provide both a blood and stool sample for a head-to-head comparison. However, only 52% of study subjects provided a stool sample for analysis, reinforcing the well-characterized challenges with patient willingness to perform stool-based testing. In subjects with paired blood and stool samples, Freenome's multiomics blood test demonstrated 100% sensitivity and 96% specificity for CRC, whereas FIT achieved 67% sensitivity and 96% specificity. "The performance of FIT in our study is consistent with that shown in other large prospective studies, which makes our results even more encouraging," said Girish Putcha, MD, PhD, Chief Medical Officer of Freenome, "since we believe such a blood test can help more people get screened for CRC than existing options, which will improve the detection of early disease and enable better clinical outcomes."

Posters will be available online at https://www.freenome.com/news-resources at the time of presentation. The following information provides details to all of the posters Freenome will be presenting at the conference:

Abstract 66:

Presenter and Title: Girish Putcha et al., Blood-based detection of early-stage colorectal cancer using multiomics and machine learning.

Poster Session C: Anal and Colorectal Cancer: Saturday, January 25: 6:30 am - 7:55 am and 12:15 pm - 1:45 pm

Poster Walk: Novel Diagnostics and Population Health: Saturday, January 25: 12:30 pm - 1:15 pm

Poster Board C16

Abstract 207:

Presenter and Title: Francesco Vallania et al., Exploratory longitudinal analysis of cfDNA to reveal potential biomarkers of CRC progression and treatment response.

Poster Session C: Anal and Colorectal Cancer Saturday, January 25, 6:30 am - 7:55 am and 12:15 pm - 1:45 pm

Poster Board K7

About Colorectal Cancer and AI-EMERGE®

Despite population screening efforts and the availability of several stool-based, non-invasive tests, more than one-third of eligible adults remain unscreened for colorectal cancer (CRC), which is the second deadliest form of cancer in the U.S. However, when detected at an early stage, the five-year relative survival rate for CRC is 90% versus 14% when detected at a late stage according to data from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program. AI-EMERGE® is a clinical study that will advance the development of a blood-based test to detect colorectal cancer early. The study is a prospective, multi-center CRC screening clinical study being conducted in patients ages 50-84 that are at average risk for CRC. The study collected blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. The study has recently closed enrollment.

About Freenome

Freenome is a biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining a deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, Freenome is developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. Freenome is headquartered in South San Francisco, California. For more information about Freenome, visit www.freenome.com and view open positions at freenome.com/careers.


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