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DeciBio Liquid Biopsy Weekly Digest
January 28th, 2020
Data from GRAIL's Circulating Cell-free Genome Atlas Study was presented at ASCO - GI last week in San Francisco. Performance specifications for both cancer detection and Tissue of Origin (TOO) classification of GI cancers were presented for GRAIL's methylation-based liquid biopsy assay. This data suggests that targeted methylation analysis of ctDNA can detect cancer, as well as guide downstream diagnostic workup by identifying the tissue of origin.
 
GRAILSensitivity for GI Cancer Detection            at >99% Specificity* GRAIL Accuracy of TOO Localization for GI Cancers*
Stage I-III Stage I-IV
Training – 73%
Validation – 71%
Training – 82%
Validation – 81%
Training – 91%
Validation 89%
*Overall performance across cancers of the esophagus, stomach, liver/bile duct, pancreas, gallbladder and colon/rectum as presented by GRAIL at ASCO GI 2020


Freenome also presented data from the trial AI-EMERGE at ASCO GI. As seen below, Freenomes multi-omic test has impressive performance for the detection of early-stage CRC, especially for stage I/II cancers. Freenome also compared their assay to other CRC screening tests (i.e., fecal immunochemical test (FIT), ctDNA and CEA) using matched samples. Combining their assay's performance against FIT testing with the fact that only 52% of patients were willing to provide a stool sample, reinforces the need for an alternative screening method using blood samples and highlights the need Freenome is aiming to address. 
 
Freenome Sensitivity for CRC Detection Freenome Specificity for CRC Detection   
Stage I/II CRC Stage III/IV CRC Stage I - IV
94% 91% 94%
 
  Freenome vs FIT** Freenome vs ctDNA** Freenome vs CEA**
  FIT Freenome ctDNA Freenome CEA Freenome
Sensitivity 67% 100% 47% 90% 31% 91%
Specificity 96% 96% 75% 100% 94% 94%
**Overall performance for all stages of CRC as presented by Freenome at ASCO GI 2020, early stage I/II data is available on ASCO poster
 

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