Data include findings generated using the RaDaR 1.0 assay to assess molecular residual disease and recurrence risk in early breast cancer

NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced that data utilizing its RaDaR^® 1.0 assay for the detection of molecular residual disease (MRD) will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 9–12, 2025, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

NeoGenomics will present new data from the SURVIVE HERoes Phase III trial and the CLEVER study, both of which used RaDaR 1.0 circulating tumor DNA (ctDNA) testing to evaluate molecular residual disease and recurrence risk. These findings reinforce the growing role of tumor-informed ctDNA approaches in early breast cancer research and recurrence monitoring.

Presentation details

The first study, titled "5-year outcomes and ctDNA findings in the CLEVER trial targeting disseminated dormant tumor cells," investigates long-term recurrence biology in patients with high-risk breast cancer and shows that positive ctDNA frequently precedes clinical recurrence. Five-year follow-up data demonstrate that RaDaR-detected ctDNA was present in most patients with disseminated tumor cells, often months before relapse. These findings reinforce the potential role that sensitive ctDNA testing can play in monitoring molecular residual disease during periods of ongoing long-term risk. Investigators from the University of Pennsylvania will present on Thursday, Dec. 11, 2025, 7:00 AM–8:30 AM CST. [PD5-02]
The SURVIVE Phase III randomized case-control trial, presented as "Reevaluating Follow-Up in Early Breast Cancer, guided by Liquid Biopsy: the SURVIVE Study (NCT05658172)," investigates whether the use of the RaDaR assay in liquid-biopsy guided follow-up may enable earlier detection of recurrence and improve overall survival. Investigators from the University Hospital Ulm, Germany, presenting on behalf of recruiting centers across Germany, will share the current status on Friday, Dec. 12, 2025, 12:30 PM–2:00 PM CST. [PS5-08-13]
The SURVIVE HERoes Phase III trial, presented as "The SURVIVE HERoes study NCT06643585: Targeting molecular relapse in breast cancer," is an ongoing therapeutic intervention arm of the SURVIVE trial, which evaluates an emerging strategy for treating patients at the point of molecular relapse, when ctDNA is detectable when using the RaDaR assay despite no radiographic evidence of disease. The study examines whether earlier intervention in HER2-positive or HER2-low early breast cancer can improve long-term outcomes. Positive study results could help establish a new, molecularly guided, individualized surveillance and treatment approach. Investigators from the University Hospital Ulm will present on Friday, Dec.12, 2025, 12:30 PM–2:00 PM CST. [PS5-07-28]

"The findings presented at this year's SABCS conference demonstrate how RaDaR-detected ctDNA can provide invaluable and actionable information to care teams as they monitor patients following their initial breast care treatment," said Tony Zook, Chief Executive Officer. "These studies represent an important step in building the evidence needed to integrate MRD insights into the routine oncology care that community oncologists and their patients deserve."

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.

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," "could," "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 include statements regarding the potential role of tumor-informed ctDNA approaches in early breast cancer research and recurrence monitoring; the potential role that sensitive ctDNA testing can play in monitoring molecular residual disease during periods of ongoing long-term risk; the possibility that liquid-biopsy guided follow-up may enable earlier detection of breast cancer recurrence and improve overall survival; the potential for RaDaR and ctDNA detection to establish new, molecularly guided, individualized surveillance and treatment approaches; and RaDaR ST's potential to provide actionable information to care teams as they monitor patients following their initial breast cancer treatment. 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, the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and filed with the SEC on February 18, 2025, as well as subsequently filed 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 www.sec.gov 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.

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NeoGenomics to Present New ctDNA Research at SABCS 2025