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NeoGenomics Launches RaDaR ST, Expanding Molecular Residual Disease Testing Across Multiple Solid Tumor Types

MWN-AI** Summary

NeoGenomics, Inc. (NASDAQ: NEO), a prominent player in oncology diagnostics, has recently launched RaDaR® ST, a novel circulating tumor DNA (ctDNA) assay designed for the detection of molecular residual disease (MRD) across a variety of solid tumor types. The company estimates that the MRD market is worth over $20 billion and is growing at an annual rate of 30%, with less than 10% market penetration currently.

According to CEO Tony Zook, RaDaR ST signifies a notable advancement in MRD testing, which is becoming increasingly important in clinical practice. This test offers patient-specific insights that can facilitate the early detection of residual disease and recurrence, often ahead of traditional imaging methods. By doing so, it empowers healthcare professionals to make more informed treatment decisions throughout the patient care timeline.

RaDaR ST employs patient-specific tumor-informed panels to identify trace amounts of tumor DNA from blood samples. Its cutting-edge methodology integrates whole-exome sequencing with sophisticated bioinformatics, allowing it to track up to 48 tumor-specific variants with an impressive limit of detection (LOD95) of 11 parts per million (ppm), thus yielding high sensitivity and specificity.

The assay has been validated through extensive clinical and real-world data, demonstrating its efficacy in early recurrence detection, identifying persistent molecular disease, and providing long-term surveillance in high-risk populations. Initially approved by Medicare for specific launch indications, NeoGenomics has also submitted two additional indications for reimbursement.

With the introduction of RaDaR ST, NeoGenomics enhances its portfolio, providing a comprehensive solution that spans cancer diagnostics, therapy selection, and personalized MRD assessment, thereby enabling better treatment guidance from diagnosis through monitoring.

MWN-AI** Analysis

NeoGenomics, Inc. (NASDAQ: NEO) has made a significant stride in advancing oncology diagnostics with the launch of its RaDaR® ST assay, aiming to tap into the burgeoning market for molecular residual disease (MRD) testing. The MRD market is projected to exceed $20 billion, experiencing an impressive growth rate of 30% annually, yet remains under-penetrated at less than 10%. This suggests a tremendous opportunity for companies like NeoGenomics to capitalize on early-stage cancer detection capabilities.

RaDaR ST's patient-specific approach for detecting circulating tumor DNA (ctDNA) represents an important innovation. The assay's capability to identify residual disease before it becomes detectable through traditional imaging methods can revolutionize treatment pathways. This advancement aligns with the ongoing shift towards precision medicine, where informed, data-driven decisions are critical in improving patient outcomes. NeoGenomics’ comprehensive offerings now enable clinicians to better monitor disease progression, supporting timely interventions tailored to individual patient needs.

The initial Medicare approval for RaDaR ST indicates the assay's potential to integrate into existing clinical frameworks, while pending reimbursement for additional indications suggests promising growth avenues. As healthcare providers increasingly adopt advanced diagnostic techniques, NeoGenomics stands to strengthen its market position.

For investors, NEO presents potential upside as it expands its foothold in a high-growth segment of oncology. Continued investment in cutting-edge technologies and an emphasis on addressing real-world clinical needs position NeoGenomics favorably within a competitive landscape. As market dynamics evolve and awareness of MRD testing increases, the company is well-poised to benefit from heightened demand, equating to possible stock appreciation over time.

Overall, for proactive investors, NeoGenomics represents a compelling opportunity within the healthcare sector, particularly as it leads in innovative cancer diagnostics. It is advisable to monitor developments closely, particularly related to the RaDaR ST’s clinical adoption and reimbursement landscape.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: Business Wire

We estimate that MRD represents a $20+ billion addressable market, growing at 30% annually, which we believe is less than 10% penetrated

NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the launch of RaDaR® 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260225078782/en/

Investor Contact
Kendra Webster
InvestorRelations@neogenomics.com

Media Contact
Andrea Sampson
asampson@sampsonprgroup.com

FAQ**

How does NeoGenomics Inc. NEO plan to capture a significant share of the $20 billion MRD market that is currently less than 10% penetrated with the RaDaR ST assay?

NeoGenomics Inc. plans to capture a significant share of the $20 billion MRD market by leveraging its RaDaR ST assay’s enhanced sensitivity and specificity for minimal residual disease detection, driving adoption through strategic partnerships and targeted marketing efforts.

What specific advancements in technology does NeoGenomics Inc. NEO believe RaDaR ST brings to MRD testing that differentiates it from conventional imaging methods?

NeoGenomics Inc. NEO asserts that RaDaR ST enhances MRD testing by leveraging advanced genomic sequencing techniques to detect minimal residual disease at a higher sensitivity and specificity compared to conventional imaging methods.

Could you elaborate on the evidence from clinical studies that supports the effectiveness of RaDaR ST in detecting molecular residual disease in patients according to NeoGenomics Inc. NEO?

Clinical studies indicate that RaDaR ST demonstrates a high sensitivity and specificity for detecting molecular residual disease in cancer patients, as evidenced by significant correlations between its results and patient outcomes, according to NeoGenomics Inc.

How does NeoGenomics Inc. NEO plan to expand its reimbursement indications for RaDaR ST following the initial approval by Medicare, and what impact might this have on market penetration?

NeoGenomics Inc. plans to expand RaDaR ST's reimbursement indications by collaborating with additional payers, conducting clinical validation studies, and enhancing physician education, which could significantly improve market penetration and accessibility for patients.

**MWN-AI FAQ is based on asking OpenAI questions about NeoGenomics Inc. (NASDAQ: NEO).

NeoGenomics Inc.

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