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Clinical OMICs – Diagnostics Companies Join to Advance Comprehensive Genomic Profiling

Clinical OMICs – Diagnostics Companies Join to Advance Comprehensive Genomic Profiling

Seven leading diagnostics developers and lab services companies today announced the launch of the Access to Comprehensive Genomic Profiling Coalition (ACGP), whose mission is to advocate for the effectiveness of comprehensive genomic profiling (CGP) in advanced cancer care. Specifically, ACGP aims to advocate for broader coverage of these tests with both public and private payers.

“The idea is that patients will get better if they have better access to these tests,” Jim Almas, M.D., chair of ACGP, and vice president and national medical director of clinical effectiveness at LabCorp tells Clinical OMICs. “It is also critical they have access to these tests for better opportunities to enroll in clinical trials.”

Current members of ACGP are Exact Sciences, Foundation Medicine, Illumina, LabCorp, QIAGEN, Roche Diagnostics, and Thermo Fisher Scientific.

CGP tests assess the genomic alterations within a patient’s cancer. Current CGP tests analyze more than 300 specific genetic markers that can help treating physicians take a more precise approach to treating an individual patient’s specific cancer type. Sequencing a tissue biopsy or a blood sample, this CGP detects the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions.

These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA to identify patients who may respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC) as one example.

CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes. In advocating for coverage of CGP, ACGP will educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.

According to Almas, the idea of bringing together leading diagnostics companies took shape in January based on conversations he had with representatives from some of the current member companies, and modeled on the success of the Coalition for Access to Prenatal Screening (CAPS).

“Nearly all of us are involved in the Friends of Cancer Research TMB Harmonization Project, which is a great program with a lot of solid people behind it,” Almas explains. “So, let’s give some thought to having the leading diagnostic companies and manufacturers sitting down at a table to say these tests are of value to patients with advanced cancer and advocating for them.”

A driving reason for the formation of ACGP is the lack of payer coverage for these tests. Almas told Clinical OMICs, that in a previous job with the Centers for Medicare & Medicaid Services (CMS), he was involved for a time in the parallel review project for the Foundation Medicine comprehensive genomic profiling test that eventually won both FDA approval and a CMS coverage decision in 2018.

“I think there was thought at that point that broad comprehensive genomic profiling, covered by Medicare, would also be picked up by commercial carriers, managed care, and Medicaid,” he notes. “It didn’t happen.”

In order to achieve the goal of broader coverage of these tests, ACGP will take a top-down education approach that seeks to provide information to all stakeholders, including clinicians, oncologists, and pathologists on the types of tests available and their benefits.

The coalition also hopes that increasing the number of advanced cancer patients receiving CGP will provide more opportunities for them to participate in clinical trials, to improve on the 2% to 8% rate of current cancer patients enrolled in these trials.

“We know there are obstacles to these tests, and you have disparities in care for the same reason,” Almas notes.  “We believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one 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.”…