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New coverage extends RaDaR ST to patients with advanced cancer on immunotherapy, expanding MRD testing across the cancer care continuum FORT MYERS, Fla.--(BUSINESS WIRE)-- NeoGenomics, Inc. (NASDAQ: NEO) , a leading provider of oncology diagnostic solutions that enable precision medicine, announced that its RaDaR ® ST molecular residual disease (MRD) assay has received expanded coverage from the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) to include immunotherapy monitoring for patients with late-stage solid tumors. Medicare coverage for RaDaR ST now includes monitoring of response to immune-checkpoint inhibitor therapy in patients with late-stage solid tumors. 1 This is the third Medicare-covered indication for RaDaR ST, which also includes HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive (HR+), HER2-negative breast cancer. NeoGenomics also has two additional RaDaR ST submissions pending with MolDX. Immunotherapy is now standard treatment across numerous common solid tumors, including lung cancer, melanoma, bladder cancer, and renal cell carcinoma, often continuing for years. However, imaging alone often cannot reliably distinguish true response from early treatment-related inflammatory changes, complicating decisions about whether to continue, adjust, or stop therapy. Longitudinal molecular testing over the course of treatment may help identify early signs of progression that might otherwise be missed and clarify response in the context of pseudoprogression (inflammation present on imaging) that can occur in treatment with immunotherapy. In lung cancer and melanoma alone, immunotherapy accounts for an estimated 55% and 70% of treated cases, respectively, underscoring how many patients could benefit from better tools to track how they are responding. 2 Evidence for RaDaR ST in the immunotherapy setting has been demonstrated across multiple studies, including melanoma, head and neck, breast, and bladder cancers. 3-6 In advanced head and neck cancer treated with immune checkpoint blockade, ctDNA dynamics tracked with survival and response to treatment. 6 “We view this coverage determination as a cornerstone of our launch of RaDaR ST,” said Tony Zook, CEO of NeoGenomics. “As immunotherapy continues to reshape solid tumor treatment, clinicians want more dynamic tools to evaluate how patients are responding over time. Personalized MRD testing delivers longitudinal molecular insights that complement traditional assessment methods throughout the patient's treatment journey. This coverage marks a critical milestone in expanding access to RaDaR ST in a large and growing indication, and we continue to anticipate further reimbursement decisions to support growth in the coming years.” RaDaR ST employs a tumor-informed approach, analyzing up to 48 patient-specific variants identified through whole-exome sequencing to detect ctDNA at a very low variant allele fraction (VAF). It supports three core clinical uses: recurrence-risk assessment after curative-intent surgery, recurrence monitoring during surveillance, and longitudinal treatment-response monitoring during systemic therapy. Across these settings, RaDaR ST has demonstrated strong analytical and clinical performance in numerous published studies spanning multiple solid tumor types with detection as low as 1ppm. 7 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, providing oncologists, pathologists, hospital systems, academic medical centers, and pharmaceutical firms with innovative diagnostic and predictive testing to deliver timely, actionable insights that guide personalized care decisions. 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, England. Forward Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “can,” “guide”, “could,” “want,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding the Company’s strategy, planned future operations and development plans and initiatives, the potential of RaDaR ST to support therapy selection and longitudinal disease monitoring in patients with advanced solid tumors; the Company’s expectations regarding the correlation between the availability of Medicare coverage and the ability of physicians to deliver timely, personalized treatment strategies for their patients; and the potential impact of Medicare coverage and potential future coverage to support wider clinical adoption of RaDaR ST. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Applicable risks and uncertainties include, among others, risks with respect to the Company’s ability to maintain Medicare coverage for its products and the market acceptance of its products, as well as the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and in the “Investors” section of our website at ir.neogenomics.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. References Coverage is provided under LCD - MolDX: Plasma-Based Genomic Profiling in Solid Tumors (L38043). Internal TAM market data on file. Weber JS, Carlino MS, Khattak A, et al. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet . 2024;403(10427):632-644. Lynce F, Mainor C, Donahue RN, et al. Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study. Nat Commun . 2024;15(1):2691. van Dorp J, Pipinikas C, Suelmann BBM, et al. High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial. Nat Med . 2023;29(3):588-592. Ruiz-Torres DA, Merkin RD, Bryan ME, et al. Personalized circulating tumor DNA dynamics inform survival and response to immune checkpoint blockade in recurrent/metastatic head and neck cancer. NPJ Precis Oncol. 2025;9(1):298. Limit of detection with 95% probability (LOD95) at 11 ppm; detection down to 1 part per million under study specific conditions (NeoGenomics data on Contacts Investor Contact InvestorRelations@neogenomics.com Media Contact Andrea Sampson asampson@sampsonprgroup.com

On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals):in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, andin combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.Today, the FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc./Roche Diagnostics), for identifying patients with HER2-positive (IHC3+ or IHC2+/ISH+) gastric, gastroesophageal junction, and esophageal adenocarcinoma for treatment with Ziihera, consistent with the approved drug labeling.Full prescribing information for Ziihera and Tevimbra will be posted on Drugs@FDA.Efficacy and SafetyEfficacy was evaluated in HERIZON-GEA-01 (NCT05152147), a randomized, three-arm, open-label, active-comparator, global trial in patients with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. Patients were randomized (1:1:1) to one of three treatment arms:Arm A: trastuzumab with investigator’s choice of combination therapy of capecitabine and oxaliplatin (CAPOX) or fluorouracil and platinum (FP).Arm B: zanidatamab-hrii in combination with CAPOX or FP.Arm C: zanidatamab-hrii in combination with tislelizumab-jsgr and CAPOX or FP.The dual major efficacy outcome measures were progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1. and overall survival (OS).Efficacy results showed statistically significant improvements in OS and PFS for Arm C (zanidatamab-hrii and tislelizumab-jsgr-containing arm) versus Arm A in patients with HER2 IHC3+ or IHC2+/ISH+ tumors. Median OS was 26.4 months (95% CI: 21.5, 30.3) in Arm C and 19.2 months (95% CI: 16.8, 21.8) in Arm A (hazard ratio 0.72 [95% CI: 0.57, 0.90]; p-value 0.0043) and median PFS was 12.4 months (95% CI: 9.8, 18.5) in Arm C versus 8.1 months (95% CI: 7.0, 8.9) in Arm A (hazard ratio 0.63 [95% CI: 0.51, 0.78]; p-value <0.0001).Arm B (zanidatamab-hrii arm) showed a statistically significant improvement in PFS compared to Arm A. OS interim results were not statistically significant at the time of the PFS analysis. Based on exploratory analyses in the HER2 IHC 2+/ISH+ population, the treatment effect in Arm B was primarily attributed to the subgroup of patients with HER2 IHC 3+ tumors. In patients with IHC 3+ tumors, median PFS was 14.2 months (95% CI: 11.7, 16.7) in Arm B and 7.6 months (95% CI: 6.9, 8.5) in Arm A (hazard ratio 0.55 [95% CI 0.43, 0.69]).The zanidatamab-hrii prescribing information includes a boxed warning for diarrhea and embryo-fetal toxicity, as well as warnings and precautions for left ventricular dysfunction and infusion-related reactions. The tislelizumab-jsgr prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.Recommended DosageThe recommended zanidatamab-hrii dose is based on body weight. For patients with a body weight of less than 70 kg, the recommended dose is 1,800 mg every three weeks or 1,200 mg every two weeks. For patients with a body weight greater than or equal to 70 kg, the recommended dose is 2,400 mg every three weeks or 1,600 mg every two weeks. The recommended tisletizumab-jsgr dose is 150 mg every two weeks, 200 mg every three weeks, 300 mg every four weeks, or 400 mg every six weeks until disease progression or unacceptable toxicity.This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada (HC) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review. Zanidatamab-hrii received Fast Track, Breakthrough Therapy, and Orphan Drug designations. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.