This section highlights FDA-related milestones and regulatory updates for drugs developed by NeoGenomics (NEO).
Over the past two years, NeoGenomics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RaDaR and circulating. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RaDaR ST FDA Regulatory Events
RaDaR ST is a drug developed by NeoGenomics for the following indication: sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RaDaR ST
- Announced Date:
- October 14, 2025
- Indication:
- sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels.
Announcement
NeoGenomics, Inc announced the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company's circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.
AI Summary
NeoGenomics, Inc. announced it will present three new posters with assay-relevant data, including ongoing interventional therapy trials, at the European Society for Medical Oncology Congress 2025 in Berlin (October 17–21). These presentations will highlight how its molecular residual disease (MRD) assay, RaDaR ST, may benefit pharmaceutical partners in drug development.
The RaDaR ST assay is a circulating tumor DNA (ctDNA) test designed to accelerate and optimize oncology drug development. It uses whole-exome sequencing of tumor samples and advanced bioinformatics to create patient-specific MRD panels. By leveraging high-depth sequencing of plasma, it delivers sensitive and specific ctDNA detection for real-time insights into tumor dynamics and treatment response.
Tony Zook, CEO, emphasized NeoGenomics’ commitment to clinical validation and interventional studies using its MRD technology. He noted that pharmaceutical sponsors seek partners offering both innovation and operational excellence to make faster, more informed decisions and advance cancer research.
As MRD gains traction in monitoring next-generation therapies, RaDaR ST strengthens NeoGenomics’ position as a precision oncology partner. Attendees can learn more at booth #4012.
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Circulating tumor DNA FDA Regulatory Events
Circulating tumor DNA is a drug developed by NeoGenomics for the following indication: For Advancing Cancer Diagnostics and Personalized Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- circulating tumor DNA
- Announced Date:
- September 11, 2024
- Indication:
- For Advancing Cancer Diagnostics and Personalized Treatment
Announcement
NeoGenomics, Inc announced that will present three studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438). NeoGenomics' data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization.
AI Summary
NeoGenomics, Inc. will present three important studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17 at booth #438. The studies highlight significant advances in circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), which help detect cancer early and optimize treatment. Researchers are using these tools to identify cancers in high-risk patients and guide personalized therapies. One study on non-small cell lung cancer examines ctDNA to spot early signs of relapse, while another evaluates ctDNA as a marker in high-risk melanoma patients. A third study shows that testing for multiple gene fusions using NGS can find more patients eligible for targeted therapies compared to more limited tests. Overall, the data underscores the growing potential of advanced molecular diagnostics for earlier cancer detection and improved treatment decisions.
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