FT. MYERS, FL / ACCESSWIRE / July 27, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading oncology testing services company, announced today that the Molecular Diagnostics Services Program (MolDx) has conveyed coverage for the RaDaR® assay, a personalized liquid biopsy for minimal residual disease (MRD) and recurrence detection.
Following this decision, effective as of March 24, 2023, the RaDaR assay is now covered for fee-for-service Medicare patients within the United States with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The coverage includes patients with a personal history of high-risk stage II/III HR+/HER2- breast cancer, five or more years from diagnosis who presently do not have evidence of disease.
NeoGenomics' tumor informed RaDaR assay has been designed to detect extremely low levels of circulating tumor DNA (ctDNA) in the blood with exceptional sensitivity and specificity. RaDaR can monitor up to 48 tumor-specific variants unique to each patient's tumor, giving patients additional time and information for important treatment management decisions.
"Gaining our first Medicare coverage decision from MolDx for breast cancer is a significant milestone for the company, the clinicians we partner with, and the patients we serve," said Chris Smith, Chief Executive Officer of NeoGenomics. "RaDaR, our MRD technology, addresses an unmet clinical need and improves clinicians' ability to accurately predict the risk of cancer recurrence."
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About RaDaR® Technology
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 secure the data we maintain.
This press release includes forward-looking statements. 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, 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 24, 2023 as well as other information previously filed with the SEC. 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.
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SOURCE: NeoGenomics, Inc.
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