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We estimate that MRD represents a $20+ billion addressable market, growing at 30% annually, which we believe is less than 10% penetrated
FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch ofRaDaR® ST, its circulating tumor DNA (ctDNA) assay for detecting molecular residual disease (MRD).
“RaDaR ST represents an important advancement in MRD testing, a rapidly growing market that remains largely untapped,” said Tony Zook, CEO of NeoGenomics. “By providing patient-specific molecular insights, the test enables clinicians to detect residual disease and recurrence sooner than conventional imaging, supporting more informed treatment decisions at each stage of care. Our goal with RaDaR ST is to give providers reliable, actionable results that can be incorporated into clinical practice and research programs, helping support informed clinical decisions and enable earlier intervention in patient care.”
RaDaR ST uses patient-specific, tumor-informed panels to detect trace amounts of tumor DNA in blood, often before recurrence is visible on imaging. The assay combines whole-exome sequencing with advanced bioinformatics to track up to 48 tumor-specific variants with a limit of detection at 95% probability (LOD95) of 11 ppm, offering high sensitivity and specificity.*
Validated through a large and growing body of clinical and real-world data, including studies in breast and HPV-negative head and neck cancers, RaDaR ST shows utility for earlier detection of recurrence, identification of patients with persistent molecular disease, and long-term surveillance in high-risk populations. The assay is approved by Medicare for initial launch indications, with two additional indications submitted for reimbursement.
“These development milestones reflect the brisk pace of innovation across our portfolio and our ongoing commitment to investing in technologies that address emerging clinical needs,” added Zook. “With the launch of RaDaR ST, NeoGenomics now offers a comprehensive solid tumor care solution that spans the continuum of cancer care from comprehensive diagnostic profiling to therapy selection and personalized MRD assessment, enabling physicians to better guide treatment decisions from diagnosis through long-term disease monitoring.”
About NeoGenomics
NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom.
*Sensitivity demonstrated across four independent analytical and clinical validation studies, with detection down to 1 part per million (ppm) under study-specific conditions. Data on file.