Bridging the gap between clinical utility and coverage: Real-world impact of unreimbursed NGS testing.

Abstract

11194 Background: Genomic testing is the cornerstone of precision oncology, revealing rare yet clinically actionable alterations that define diagnosis, risk stratification, and treatment choice. Despite its proven clinical utility, inconsistent coverage and inadequate reimbursement constrain routine use, reflecting a persistent misalignment between clinical value and payer policy. Evaluating real-world utilization and clinical impact of unreimbursed testing can highlight critical gaps in standard oncology care. Methods: Molecular profiles of 7,271 patients were analyzed by integrating Neogenomics sequencing data (09/2025 – 12/2025) with standardized clinical data (cancer diagnoses, ICD-10 codes, medication records, molecular testing results) extracted from comprehensive electronic medical records using the xCures platform. Results: Cohort of 7,271 patients insured by commercial (58%), managed (22%), or government (20%) plans had unreimbursed tests with orders originating primarily from hospitals (49%) and physician groups (42%). Testing predominantly targeted hematologic malignancies ( > 90%), with solid tumors representing 8%. Among patients with available medical records (n = 3,409), hematologic panels remained most common (67%), led by the Neo Comprehensive Myeloid (n = 1,064), NeoTYPE MDS/CMML Profile (n = 485), Neo Comprehensive Heme (n = 385), NeoTYPE CLL Profile (n = 299) and NeoTYPE Lymphoid Disorders Profile (n = 211). Abnormal molecular findings were identified in 1,056 patients (%), including 470 patients with pathogenic or likely pathogenic variants (SNVs, deletions, insertions, fusions and substitutions), with 23% (104/470) of alterations (i.e. ABL1, ERBB3, KDR, MAP2K1, TOP1, TSC1, TSC2) not identified by previous methods. Of 66 patients receiving targeted therapy after testing, 4 (6%) were treated within 60 days for pathogenic alterations (, JAK2, KIT, BCR-ABL1) identified by Neogenomics. Eleven (17%), initially with unspecified diagnoses, received therapies (venetoclax, obinutuzumab, lenalidomide) for newly defined indications, and 2 (3%) were treated (venetoclax, lenalidomide) based on relevant biomarkers (NPM1, SF3B1) of sensitivity, all guided by test results within 60 days. Among 386 patients with initially unspecified conditions, EMR for 137 patients (36%) confirmed diagnoses within 60 days. Conclusions: Genomic testing delivers substantial clinical value by enabling rapid, definitive diagnoses and informing timely, targeted treatment decisions. Despite inconsistent payer coverage, these data show that NGS testing frequently identifies actionable alterations and biomarkers not previously identified by standard testing that directly impact patient management. Aligning reimbursement policies with anticipated clinical utility is critical to closing gaps in standard care and expanding equitable access to precision oncology.