NeoGenomics Announces Commercial Availability of the RaDaR(R) Molecular Residual Disease Test

Rhea-AI Summary

NeoGenomics, Inc. (NASDAQ:NEO) announced the commercial launch of the RaDaR® assay, a liquid biopsy test for minimal residual disease (MRD), which detects trace amounts of circulating tumor DNA post-cancer treatment. Recent studies highlight its effectiveness, especially in breast cancer, and it has been validated for use across multiple cancer types, including colorectal and lung cancers. This personalized test, with a detection limit of 0.001%, has received Breakthrough Device Designation from the FDA. The RaDaR assay aims to enhance treatment decisions by identifying residual disease much earlier than traditional methods.

Positive

• Commercial launch of RaDaR assay, enhancing oncology diagnostics.
• Validated across multiple cancer types including breast, colorectal, lung, and head and neck.
• Achieved Breakthrough Device Designation from the FDA, signaling recognition of its innovative approach.

Negative

• None.

FT MYERS, FL / ACCESSWIRE / March 16, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services, announced today the commercial availability of the RaDaR^® assay, a liquid biopsy test for molecular/minimal residual disease (MRD). MRD is the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment. The announcement comes after several recent publications demonstrating the clinical utility of the RaDaR test, particularly in the breast cancer space, with the CHiRP study published at ASCO 2022, and presentations of data for the TRACER and cTRAK-TN study cohorts at the most recent SABCS conference.

"The RaDaR assay addresses one of the most difficult challenges in oncology diagnostics by allowing oncologists to spot small amounts of cancer cells with greater sensitivity and much earlier than with standard tests," said Chris Smith, Chief Executive Officer, NeoGenomics. "The detection of minimal residual disease and recurrence is a new frontier in cancer diagnostics that has the potential to significantly impact treatment decisions and ultimately, patient outcomes."

Results from the RaDaR test can help clinicians determine whether their cancer patients have residual disease after curative intent therapy or surgery. This can help inform treatment decisions for patients, and can be utilized to monitor patients to detect recurrent disease ahead of traditional monitoring methods.

The RaDaR assay has been available over the last year for use in clinical research studies and pharmaceutical collaborations and is now fully available to U.S. clinicians. The RaDaR assay is available to order for breast, colorectal, lung, and head and neck cancer patients.

About RaDaR^®

The RaDaR^® assay is a personalized, tumor-informed, highly sensitive technology that tracks a set of up to 48 tumor-specific variants in cell-free DNA (cfDNA) within a cancer patient's blood plasma. Built on the proven InVision^® platform, the personalized RaDaR assay has been designed to detect minimal residual disease (MRD) and recurrence following curative intent or definitive treatment, and early signs of relapse, and has been validated for clinical use in breast, colorectal, head and neck, as well as lung cancers. MRD is the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment.

The RaDaR workflow leverages proprietary algorithms to both create personalized RaDaR panels for each patient and analyze results of a RaDaR test, all culminating in an exceptionally sensitive test with one of the industry's leading limit of detections (LODs) down to 0.001%.

The RaDaR assay is a laboratory developed test (LDT) which has been granted Breakthrough Device Designation by the US FDA for use in the detection of MRD in early-stage cancer patients and has received the CE mark for the detection of MRD and recurrence. RaDaR is also available for pharmaceutical, biotechnology companies and commercial entities in early through late-stage cancer development programs across a range of cancer types.

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services, providing one of the most comprehensive oncology-focused testing menus in the world to help physicians diagnose and treat cancer.

NeoGenomics is committed to connecting patients with life altering therapies and trials. We believe that, together, with our partners, we can help patients with cancer today and the next person diagnosed tomorrow. In carrying out these commitments, NeoGenomics adheres to all applicable state and federal data protection laws, provides transparency and choice to patients regarding the handling and use of their data through expressed authorizations and our Notice of Privacy Practices, and has invested in leading technologies to ensure the data we maintain is secured at all times.

Headquartered in Fort Myers, FL, NeoGenomics operates CAP accredited and CLIA certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo and San Diego, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Cambridge, UK, Rolle, Switzerland, and China. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia.

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," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project, "guidance," "plan," "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 improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. 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 statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, respond to the effects of the COVID-19 outbreak, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, and the risks identified under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 23, 2023 as well as other information previously filed with the SEC.

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, 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.

For further information, please contact:

NeoGenomics, Inc.
Vishal Sikri
President, Advanced Diagnostics
Vishal.Sikri@neogenomics.com
T: +1-847-840-3702

Kendra Sweeney
Vice President, Investor Relations and Communications
Kendra.Sweeney@neogenomics.com
T: +1-239-877-7474

SOURCE: NeoGenomics, Inc.

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FAQ

What is the RaDaR assay from NeoGenomics?

The RaDaR assay is a liquid biopsy test that detects minimal residual disease (MRD) using circulating tumor DNA, aiming to improve cancer treatment decisions.

How does the RaDaR assay impact cancer treatment?

The assay allows for earlier detection of residual disease, enabling oncologists to make informed treatment decisions and monitor patients more effectively.

In which cancers is the RaDaR assay validated?

The RaDaR assay has been validated for breast, colorectal, lung, and head and neck cancers.

What is the significance of the FDA's Breakthrough Device Designation for RaDaR?

The Breakthrough Device Designation indicates that the RaDaR assay represents a significant advancement in cancer diagnostics and may expedite its availability to patients.