Data Supports the Application of RaDaR™ MRD Assay Across Tumor Types
Early Research on Potential Biomarker in Melanoma Patients Unresponsive to Immunotherapy
FT. MYERS, FL / ACCESSWIRE / September 7, 2022 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announces that its liquid biopsy focused subsidiary Inivata Limited ("Inivata"), alongside collaborators, will present new data on its RaDaR™ assay for the detection of minimal residual disease (MRD) and recurrence at the European Society for Medical Oncology (ESMO) Congress, taking place September 9th-13th, 2022. NeoGenomics and Inivata will host a joint booth in the exhibition hall at the conference.
Data will be presented from the single-center prospective cohort ‘LIONESS' study in head and neck squamous cell carcinoma (HNSCC) patients receiving primary surgery with curative intent. The study demonstrated that the RaDaR assay was able to detect ctDNA in 100% of cases with confirmed clinical recurrences, highlighting the significant potential of the assay to guide treatment decisions and improve disease outcome.
Inivata and collaborators will also present updated follow-up data and biomarker analysis from a study investigating administration of pre-operative ipilimumab and nivolumab for the treatment of advanced urothelial cancer. In the updated study, the RaDaR assay was used to confirm the association of pre-operative plasma ctDNA detection with pathological response that was observed in the earlier analysis. Results from the complete cohort will be presented at the ESMO Congress.
NeoGenomics will present early research data from a collaboration with Biognosys and University of Zurich showing PAK4 as a potential biomarker for poor response to immunotherapy in melanoma patients. Elevated levels of PAK 4 were found in tumor samples of non-responder patients suggesting that the immune mechanisms of PAK4 are different in melanoma patients responding to immunotherapy.
Vishal Sikri, Presidentand Chief Commercial Officer of Inivata, and President, Pharma Services, NeoGenomics, said: "The data from these latest studies further highlight the potential role of RaDaR in guiding treatment decisions, with applicability across different tumor types. We believe that the assay has the potential to transform cancer care as we progress towards broad-scale commercialization." Alongside this we will present early data that may help us understand why some melanoma patients do not respond to immunotherapy. Research in identifying biomarkers is an important step in our development of diagnostics for cancer patients."
Abstracts are now available on the ESMO website and accompanying posters will be available to view during the conference, via the ESMO e-poster site, together with audio description.
Details of the abstracts are as follows:
Title: PAK4 as a potential marker for poor response to immunotherapy in melanoma patients
Abstract No: 869P
Speaker: Anna Juncker-Jensen
Date and Time: Saturday, 10 September 2022, Poster session 10, 12:00 PM-1:00PM CEST
Title: Liquid biopsy for detection of molecular residual disease and recurrence in head and neck squamous cell carcinoma
Abstract No: 684P
Speaker: Susanne Flach
Date and Time: Sunday, 11 September 2022, Poster session 10, 2:00 PM-3:00 PM CEST
Title: Updated follow-up data and biomarker analysis of pre-operative ipilimumab and nivolumab in locoregional advanced urothelial cancer (NABUCCO)
Abstract No: 1770P
Speaker: Chantal F. Stockem
Date and Time: Monday, 12 September 2022, Poster session 18, 3:00 PM-4:00 PM CEST
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 for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development.
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 seeks to adhere to all relevant data protection laws, to provide transparency and choice to patients regarding the handling and use of their data through our Notice of Privacy Practices, and invest 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 Carlsbad, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Rolle, Switzerland; Singapore 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.
We routinely post information that may be important to investors on our website at www.neogenomics.com.
Inivata is the liquid biopsy focused subsidiary of NeoGenomics Laboratories (NASDAQ: NEO). Inivata's proven InVision™ liquid biopsy platform unlocks essential genomic information from a simple blood draw which may be used by clinicians to guide personalized cancer treatment, to monitor response to treatment and to detect relapse. The commercially available InVisionFirst™-Lung test offers highly sensitive testing and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata's personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence in certain cancers and has been granted Breakthrough Device Designation by the US FDA. Inivata is partnering with pharmaceutical, biotechnology companies and commercial entities in early through late-stage cancer development programs across a range of cancer types. The InVisionFirst-Lung test and RaDaR are laboratory developed tests (LDTs) performed by Inivata's CLIA certified, CAP accredited laboratory in Research Triangle Park, North Carolina, USA. Inivata also has R&D laboratories in Cambridge, UK. Inivata's technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge.
About the RaDaRTM assay
Inivata's 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 Inivata's proven InVision™ platform, the personalized RaDaR assay has been designed to detect MRD following curative intent or definitive treatment, and early signs of relapse, and has been validated for clinical use in lung, head and neck, and breast cancers. 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.
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 the future success of the Company. 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 risks identified under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 25, 2022 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:
Director, Investor Relations and Corporate Development
T: 239.768.0600 x2726
SVP Marketing and Communications
+44 (0)7900 430235
Inivata Media Contacts:
Consilium Strategic Communications
Chris Gardner/Angela Gray/Genevieve Wilson
Alix Floyd (US)
[email protected] +44 (0)20 3709 5700
SOURCE: NeoGenomics, Inc.