7 Leading Diagnostic Companies Unite to Form Access to Comprehensive Genomic Profiling Coalition

The Access to Comprehensive Genomic Profiling Coalition (ACGP) has been formed by 7 leading diagnostic companies and laboratory providers across the United States, which will advocate for appropriate broad health insurance coverage of comprehensive genomic profiling (CGP) for patients with advanced-stage cancer, according to a press release.

The ACGP members include Exact Science, Foundation Medicine, Illumina, LabCorp, Qiagen, Roche Diagnostics, and Thermo Fisher Scientific. Performing CGP testing soon after diagnosis in advanced cancer can better inform the management of these patients, including treatment decisions and patient care that could improve clinical outcomes. Through advocacy for broader CGP coverage, the coalition will educate health insurers and other healthcare stakeholders about the clinical utility, as well as the economic value of, CGP testing.

“Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade,” said Jim Almas, MD, vice president and national medical director of Clinical Effectiveness at LabCorp, and chairman of ACGP, in a statement. “The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments.”

CGP tests are used to assess the genomic alterations within a patient’s cancer in order to inform decisions about personalized treatment approaches. Next-generation sequencing (NGS) approaches us a tissue or blood sample to detect the 4 main classes of alterations that are known to drive cancer growth, including base substitutions, insertions, and deletions; copy number alterations (CNAs); and rearrangements or fusions.

NGS tests can revel clinically relevant alterations and biomarkers in the tumor DNA or DNA, which will help physicians identify patients who may respond to a specific targeted therapy or immunotherapy that can be more effective with fewer side effects. CGP can be used to predict benefit across a variety of multiple targeted therapies and cancer indications.

Although benefit is noted for this targeted approach, some health insurers rely on an outdated framework to evaluate coverage for CGP, which is creating a disparity in access across patient populations. This type of testing is not covered by most commercial insurance plans, while public or government plans, such as Medicare, do. This limited insurance coverage can prevent physicians from ordering CGP tests for their patients.

“There is no question that obstacles to coverage have inhibited physicians from ordering comprehensive genomic profiling,” stated Almas. “Additionally, we believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of 1 CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates.”

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_{Leading diagnostics companies join forces to establish the access to comprehensive genomic profiling coalition (ACGP). News Release. November 17, 2020. Accessed November 17, 2020. https://bit.ly/3f5YU1K}