About ACGP

Comprehensive genomic profiling (CGP) is a method of testing tumors that utilizes next-generation sequencing (NGS) to detect the four main classes of genomic alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. CGP can be performed on multiple specimen types including FFPE tissue, peripheral whole blood, bone marrow aspirate or extracted nucleic acid.

Single biomarker testing identifies alterations that are confined to a single gene but may potentially miss clinically relevant mutations in additional genes. Hotspot testing can test multiple genes at a time but is confined to commonly altered regions within those genes, potentially missing other clinically relevant classes of alterations.

CGP simultaneously detects multiple types of genomic alterations across a broader number of genes, including pan-tumor biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB). For a growing number of genomic alterations with FDA targeted therapies, CGP is the only method of detection.

CGP performed soon after a diagnosis of advanced cancer provides important insights that help physicians make more informed decisions about personalized treatment approaches. Physicians can use CGP to detect possible underlying oncogenic drivers that may predict patient response, or lack thereof, to multiple targeted therapies across multiple cancer indications. Most importantly, CGP can identify patients who are eligible for clinical trials.

CGP changes the way physicians treat patients, by informing the use of the most appropriate targeted therapy, while maximizing patient benefit and avoiding unnecessary toxicities associated with potentially non-efficacious and expensive therapies. Furthermore, CGP allows oncologists to answer a key question: “Which drugs and which clinical trials are appropriate for my patient?” Single gene tests or hot-spot panels limit the information available to a patient and their oncologist.

Some health insurers use an outdated framework to assess the clinical utility of CGP, which has created a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do.

The ACGP will work to educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.