Genomic Testing Cooperative Completes New York State Approval and Medicare (Palmetto) Coverage for all DNA and RNA Tests Offered for Molecular Profiling of Hematologic and Solid Tumors

On June 23, 2021 Genomic Testing Cooperative, LCA (GTC) reported that the New York State Clinical Evaluation Program (CLEP) has completed their evaluation and approved all GTC’s Next Generation Sequencing (NGS) profiling tests for hematologic neoplasms and solid tumors (Press release, Genomic Testing Cooperative, JUN 23, 2021, View Source [SID1234584269]). This includes:

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-GTC Hematology Profile (177 genes)
-GTC Hematology Fusion/Expression (1408 genes)
-GTC Hematology PLUS (177 DNA + 1408 RNA)
-GTC Liquid Biopsy, Hematology Profile (177 genes)
-GTC Solid Tumor Profile (434 genes)
-GTC Solid Tumor Profile Fusion/Expression (1408 genes)
-GTC Solid Tumor PLUS (434 DNS + 1408 RNA)

These tests are also covered by Medicare Administrative Contractor Palmetto GBA (MolDx). The tests are carefully designed to provide cost-effective comprehensive evaluation of clinically relevant molecular abnormalities and biomarkers.

"At GTC, we believe that all patients with cancer have the right to have their cancer fully molecularly profiled and for their physicians to be able to discuss their treatment options prior to initiating therapy. Medicare coverage combined with NY state approval make this testing easily accessible for cancer patients living in NY. Our cooperative (Co-Op) business model enables other laboratories and large oncology practice groups to obtain similar coverage and approval when they internalize our tests" said Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer. "Our goal is to improve lives of cancer patients by democratizing NGS-based cancer profiling. We continue to collaborate with other Co-Op members to develop and validate new tests to address minimal residual disease, early diagnosis and other specific clinical indications" added Dr. Albitar.

GTC is first-in-class diagnostic company based on a cooperative business model. Using the most recent advances in NGS technology, GTC tests can be performed on minute samples including needle aspiration samples. Analysis of sequencing runs, curating data and interpretation of results is performed using proprietary algorithms/artificial intelligence (AI) software’s specially designed and developed for GTC’s technology. Cancer profiling combining DNA and RNA data is the most thorough approach not only for selecting therapeutic approaches and targeted therapy but also to help in establishing the diagnosis and classification of tumors, prognosis, and determining early relapse risk. GTC Hematology liquid biopsy is especially designed to be comprehensive and to replace the need for performing a bone marrow biopsy, which is a painful procedure and can be associated with complications.