NeoGenomics, Inc. is a clinical laboratory company, which engages in cancer genetics diagnostic testing and pharma services. It operates through the Clinical Services and Pharma Services segments. The Clinical Services segment offers cancer testing services to community-based pathologists, hospitals, academic centers, and oncology groups. The Pharma Services segment focuses on supporting pharmaceutical firms in drug development programs by supporting various clinical trials and research. It also provides testing services in support of its pharmaceutical clients' oncology programs from discovery to commercialization. The company was founded by Michael T. Dent on October 29, 1998 and is headquartered in Fort Myers, FL.
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- NeoGenomics' RaDaR ST molecular residual disease (MRD) assay received expanded Medicare coverage from CMS's MolDX program for monitoring response to immune-checkpoint inhibitor therapy in late-stage solid tumors. - This marks the third Medicare-covered indication for RaDaR ST, joining HPV-negative head and neck squamous cell carcinoma and a subset of HR+/HER2-negative breast cancer. - Immunotherapy accounts for an estimated 55% and 70% of treated lung cancer and melanoma cases, respectively, underscoring the need for tools that distinguish true response from pseudoprogression. - RaDaR ST uses a tumor-informed approach analyzing up to 48 patient-specific variants via whole-exome sequencing, detecting ctDNA at levels as low as 1 ppm.
- Rigel Pharmaceuticals named Alison L. Hannah, M.D., as Executive Vice President and Chief Medical Officer, effective July 1, 2026, succeeding Lisa Rojkjaer, M.D. - Dr. Hannah brings decades of oncology drug development experience, including prior roles at CytomX Therapeutics and SUGEN, and has served on Rigel's Board of Directors since May 2021. - Her appointment comes as Rigel advances its lead pipeline asset R289, a dual IRAK1/4 inhibitor, through a Phase 1b study in relapsed or refractory lower-risk myelodysplastic syndrome. - The company expects to complete enrollment and select a recommended Phase 2 dose for R289 in the second half of 2026, with preliminary data anticipated by year-end.
- NeoGenomics announced the availability of PanTracer Pro on February 12, 2026, combining comprehensive genomic profiling with diagnosis-directed immunohistochemistry and ancillary testing for advanced solid tumors. - The test features a built-in reflex to PanTracer LBx liquid biopsy assay when tissue is insufficient, maintaining diagnostic momentum without restarting the testing process. - PanTracer Pro addresses fragmented testing workflows and treatment delays in cancer care by integrating broad genomic profiling and customized diagnostic testing into a single order. - The launch comes amid challenging market conditions for NeoGenomics, with the stock declining 11.0% over 30 days and 21.1% over one year.
- Medra raised $52 million in Series A funding led by Human Capital to develop AI-powered robots that autonomously conduct biological experiments for drug discovery. - The company's Physical AI system runs end-to-end experiments without human input while its Scientific AI designs experiments and interprets results to refine drug development theories. - Medra has already partnered with major biopharmaceutical companies including Genentech, Addition Therapeutics, and Cultivarium to advance early drug discovery efforts. - The funding will support building one of the largest autonomous laboratories in the United States, scheduled to launch next year, addressing the industry's 10-15 year drug development timeline.
- NeoGenomics presents its RaDaR ST circulating tumor DNA assay at ESMO Congress 2025, designed to accelerate oncology drug development through patient-specific molecular residual disease detection. - The assay uses whole-exome sequencing and advanced bioinformatics to create personalized MRD panels, delivering highly sensitive ctDNA detection from plasma samples for real-time tumor monitoring. - Three new posters from European collaborators demonstrate clinical validation of the MRD technology in interventional therapy trials, strengthening NeoGenomics' position in precision oncology partnerships. - The launch positions NeoGenomics as a key partner for pharmaceutical companies seeking innovative diagnostic solutions to monitor responses to next-generation cancer therapies.
- The U.S. District Court for the Middle District of North Carolina granted NeoGenomics' motion for summary judgment, invalidating all of Natera's asserted patent claims for ineligible subject matter. - The court ruling allows NeoGenomics to freely commercialize its RaDaR ST assay (formerly RaDaR 1.1) and has submitted the test to CMS for clinical reimbursement coverage. - Natera maintains that the invalidated patents are distinct from U.S. Patent No. 11,519,035, which previously secured an injunction against NeoGenomics' RaDaR v1.0 product. - Both companies operate in the competitive minimal residual disease (MRD) testing market, with Natera holding over 500 issued or pending patents worldwide and evaluating appeal options.
- NeoGenomics has commercially launched c-MET CDx for NSCLC, a companion diagnostic assay that detects c-Met protein overexpression in advanced non-small cell lung cancer patients with a 48-hour turnaround time. - The diagnostic test supports patient selection for newly FDA-approved targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), offering a precision medicine approach for a biomarker observed in up to 50% of advanced NSCLC patients. - This validated companion diagnostic complements NeoGenomics' broader PanTracer™ portfolio, enhancing comprehensive biomarker profiling capabilities for lung cancer treatment decisions.
- NeoGenomics has completed its acquisition of Pathline, LLC, a CLIA/CAP/NYS-certified laboratory based in New Jersey, strengthening its commercial footprint in the historically underpenetrated Northeast market. - The strategic acquisition provides NeoGenomics with New York state approvals and is expected to significantly boost revenue and contribute to earnings by 2026 through operational synergies. - The integration will expand patient access to NeoGenomics' comprehensive oncology test menu in the Tri-state area, particularly enhancing molecular and hematology-oncology testing capabilities.
- Moderna and Merck's personalized cancer vaccine mRNA-4157, combined with Keytruda, demonstrated a 65% reduction in risk of distant metastasis or death in high-risk melanoma patients. - The Phase 2b KEYNOTE-942 trial showed significant improvement in recurrence-free survival, with 79% of combination therapy patients versus 62% on Keytruda alone remaining disease-free at 18 months. - Based on these promising results, the companies are advancing to Phase 3 trials later this year, with the treatment already receiving FDA breakthrough designation and EMA PRIME status.
- Adaptive Biotechnologies reported 42% growth in its Minimal Residual Disease (MRD) business for 2024, with clonoSEQ test volume increasing 35% to 76,105 tests delivered throughout the year. - The company secured a 17% increase in Medicare reimbursement rates for clonoSEQ tests and expanded Medicare coverage to include Mantle Cell Lymphoma, enabling new promotional efforts. - Despite overall revenue growth of 5% to $179 million in 2024, Adaptive reduced its net loss to $159.6 million from $225.3 million in 2023, with a focus on achieving MRD profitability in 2025.
