New Genomics and Liquid Biopsy Inivata and its collaborators to present new data at ESMO 2022

The data support the application of the RDaR™ MRD assay across tumor types

Early investigation of potential biomarkers 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 and global oncology contract research services today announced that liquid biopsy-focused Inivata Limited (“Inivata”), along with collaborators, will provide new data on its RaDaR™ assay for limit detection Minimal Residual Disease (MRD) and Recurrence at the European Society of Medical Oncology (ESMO) Conference, to be held September 9-13, 2022. NeoGenomics and Inivata will host a joint booth in the exhibition hall of the conference.

Data will be presented from a prospective, single-center cohort study “LIONESS” in patients with head and neck squamous cell carcinoma (HNSCC) 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 recurrence, highlighting the great potential of the assay to guide treatment decisions and improve disease outcomes.

Inivata and collaborators will also provide updated follow-up data and biomarker analysis from a study investigating the preoperative administration of ipilimumab and nivolumab for the treatment of advanced urothelial carcinoma. In the updated study, the RaDaR assay was used to confirm the association of preoperative plasma ctDNA detection with the pathological response observed in the previous analysis. The results of the full set will be presented at the ESMO Conference.

NeoGenomics will present early research data from a collaboration with Biognosys and the University of Zurich showing PAK4 as a potential biomarker for poor response to immunotherapy in melanoma patients. Elevated levels of PAK4 were found in tumor samples of non-responders patients suggesting that the immune mechanisms of PAK4 differ in melanoma patients who respond to immunotherapy.

Vishal Sikri, President and Commercial Director of Inivata, and Head of Pharma Services, NeoGenomics said: “Data from these recent studies further highlight the potential role of RaDaR in guiding treatment decisions, with potential for application across different types of tumors. We believe screening has the potential to transform cancer care as we move toward commercialization at scale.” Besides, we will provide early data that may help us understand why some melanoma patients do not respond to immunotherapy. Research into identifying biomarkers is an important step in our development of diagnoses for cancer patients.”

Abstracts are now available on the ESMO website and posters accompanying the presentation during the conference will be available, via the ESMO poster website, along with an audio description.

The details of the abstracts are as follows:

Title: PAK4 as a potential marker of poor response to immunotherapy in melanoma patients
Summary number: 869P
Speaker: Anna Juncker Jensen
Date and time: Saturday, 10 September 2022, Poster Session 10, 12:00 PM – 1:00 PM CEST

Title: Liquid biopsy for residual molecular pathology and recurrence of squamous cell carcinoma of the head and neck
Summary number: 684P
Speaker: Susan Flach
Date and time: Sunday, September 11, 2022, Poster Session 10, 2:00 PM – 3:00 PM CEST

Title: Update of follow-up data and biomarker analysis of preoperative ipilimumab and nivolumab in in situ advanced urothelial carcinoma (NABUCCO)
Summary number: 1770P
Speaker: Chantal F. Stock
Date and time: Monday, September 12, 2022, Poster Session 18, 3:00 PM – 4:00 PM CEST

About NeoGenomics, Inc.

NeoGenomics, Inc. Specializing in cancer genetics testing and information services, offering one of the world’s most comprehensive oncology-focused test lists to clinicians to help them diagnose and treat cancer. The company’s pharmaceutical services division serves pharmaceutical clients in clinical trials and drug development.

NeoGenomics is committed to connecting patients with life-changing treatments and experiences. We believe that, with our partners, we can help cancer patients today and the next person diagnosed tomorrow. In implementing these commitments, NeoGenomics strives to comply with all relevant data protection laws, to provide patients with transparency and choice regarding the processing and use of their data by notifying our privacy practices, and investing in leading-edge technologies to secure the data we hold. Insured at all times.

NeoGenomics is headquartered in Fort Myers, Florida and operates CAP-certified and CLIA-accredited 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 companies, integrated service delivery networks, managed care organizations throughout the United States, and pharmaceutical companies in Europe and Asia.

We routinely publish information that may be of interest to investors on our website at www.neogenomics.com.

About Enivata

Inivata is a subsidiary that focuses on liquid biopsy for NeoGenomics Laboratories (NASDAQ:NEO). Inivata’s installed InVision™ liquid biopsy platform unlocks essential genomic information from a simple blood draw that clinicians can use to guide personalized cancer treatment, to monitor treatment response and to detect relapse. The commercially available InVisionFirst™-Lung Test provides a highly sensitive test and provides molecular insights that enable clinicians to make more informed treatment decisions for patients with advanced NSCLC. Inivata’s custom RaDaR™ test allows residual disease detection with a high degree of sensitivity and frequency in some cancers, and has been awarded a breakthrough device designation by the U.S. Food and Drug Administration. Inivata partners with early-stage pharmaceutical and biotechnology companies and commercial entities through late-stage cancer development programs across a range of cancer types. The InVisionFirst-Lung and RaDaR test are lab-developed tests (LDTs) that are performed by Inivata’s CLIA-accredited laboratory and CAP-accredited in Research Triangle Park, North Carolina, USA. Inivata also has research and development laboratories in Cambridge, UK. The Inivata technology is based on groundbreaking research from the UK’s Cambridge Institute for Cancer Research at the University of Cambridge.

About RaDaRTM to examine

Inivata’s RaDaR™ assay is a personalized, tumor-informed, highly sensitive technology that tracks a collection of up to 48 tumor-specific variants in cell-free DNA (cfDNA) within a cancer patient’s blood plasma. The personalized RaDaR assay, built on the proven Inivata™ platform, is designed to detect MRD after therapeutic or definitive treatment intent, early signs of relapse, and has been validated for clinical use in lung, head, neck and breast cancer. The RaDaR test is a laboratory-developed test (LDT) that has been awarded a Breakthrough Device designation by the US Food and Drug Administration for use in the detection of MRD in early-stage cancer patients and has been CE marked for the detection and recurrence of MRD.

forward-looking statements

This press release contains forward-looking statements. Such forward-looking statements may generally be identified by the use of words such as “expect,” “expect,” “plan,” “could,” “will,” “may,” “will,” “believe,” “estimate,” “predict” and “objective.” and “project”, “direction”, “plan” and “potential” and other words with a similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding the company’s future success. 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 in this release. Applicable risks and uncertainties include the risks identified under the heading “Risk Factors” in the company’s annual report on Form 10-K for the year ended December 31, 2021 and submitted to the Securities and Exchange Commission on February 25, 2022 in addition to other information previously submitted to the Securities and Exchange Commission.

Investors are cautioned not to place undue reliance on the forward-looking statements contained in this press release. We encourage you to read our filings with the SEC, available at www.sec.govto discuss 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 such statements. Our business is subject to significant risks and uncertainties, including those referred to above. Investors, potential investors, and others should carefully consider these risks and uncertainties.

For more information, please contact:

Charlie Edson
Investor Relations and Corporate Development Manager
T: 239.768.0600×2726
M: 952.221.8816
charlie.eidson@neogenomics.com

Karen Chandler Smith
Senior Vice President of Marketing and Communications
Enivata
+44 (0) 7900 430235
karen.chandler-smith@inivata.com

Inivata Media Contacts:

Consilium Strategic Communications
Chris Gardner / Angela Gray / Genevieve Wilson
Alex Floyd (USA)
inivata@consilium-comms.com +44 (0) 20 3709 5700

source: NeoGenomics, Inc.

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