FT. MYERS, FL/ACCESSWIRE/June 21, 2022/NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, today confirms that its liquid biopsy-focused subsidiary Inivata Limited (“Inivata”) has announced new data in support of its RaDaRMT for detection of minimal residual disease (MRD) and recurrence in patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2) negative high-risk breast cancer -).
The data, from the CHiRP study (Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer), was published in the Journal of Clinical Oncology and was presented in part at ASCO 2022® Annual Meeting held June 3-7, 2022 in Chicago, IL.
In collaboration with the Dana-Farber Cancer Institute, the AstraZeneca-supported study used Inivata’s RaDaR personalized MRD test to examine ctDNA and its association with metastatic recurrence in patients with HR+ HER2 breast cancer – at high risk and at an early stage at least five years after diagnosis. – when more than half of metastatic recurrences are known.
The RaDaR assay used patient-specific primer panels to analyze cDNA in blood samples from the cohort of 83 patients. Specimens were collected every 6 to 12 months, beginning at a median time of 8.4 years (range, 4.9 to 20 years) after initial diagnosis, and followed for clinical tumor recurrence. The median duration of follow-up was 2 years from the first blood sample.
Ten percent of patients had positive MRD results during the study. In the 6 cases of distant metastases in the cohort, the cDNA was previously identified using the RaDaR test with a median delay of one year. None of the patients with a positive MRD test – which included two additional patients who have not yet experienced a recurrence – had experienced metastatic recurrence at the time of the first plasma sample.
The data highlights the potential of the RaDaR assay to provide an early predictor of tumor recurrence which, in turn, may enable earlier intervention, and demonstrates that tumour-informed ctDNA assays can be used successfully many years later. diagnosis and treatment of the original tumour. .
David Eberhard MD PhD, Chief Medical Officer at Inivata, commented: “To our knowledge, these are the first data to be published on plasma cDNA analysis for the detection of MRD in patients with late adjuvant HR+ breast cancer, building on our database existing data in breast cancer as well as in other indications. These results support the potential benefits of the clinical utility of the RaDaR assay in improving patient outcomes. The data will be useful to inform future study of liquid biopsy to personalize treatment and prevent or delay late recurrence of early-stage breast cancer.“
Marla Lipsyc-Sharf, MD, clinical oncology fellow at the Dana-Farber Cancer Institute, said: “The results of the CHiRP study mark an important step in helping us understand the baseline prevalence and role of ctDNA in the late adjuvant setting of HR+ breast cancer. The data demonstrates how important targeting multiple variants using an individualized test, such as the RaDaR test, can be in identifying MRD-positive patients. It is exciting to see these data highlight the promise of this method and I hope that with further studies, earlier detection of disease may allow for earlier intervention and more positive outcomes for the most at risk..”
About NeoGenomics, Inc.
NeoGenomics, Inc. specializes in cancer genetic testing and information services, providing one of the world’s most comprehensive oncology-focused test menus for physicians to help diagnose and treat cancer. 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 therapies and trials. We believe that together, with our partners, we can help cancer patients today and the next person diagnosed tomorrow. In carrying out these commitments, NeoGenomics adheres to all relevant data protection laws, provides transparency and choice to patients regarding the processing and use of their data through our Notice of Privacy Practices, and has invested in state-of-the-art technologies to ensure the security of the data we store. always.
Based in Fort Myers, Florida, NeoGenomics operates CAP-accredited and CLIA-certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo, Carlsbad, Calif.; Research Triangle Park, North Carolina; Houston, TX; Atlanta, Georgia; Nashville, TN; 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 and managed care organizations in the United States, as well as pharmaceutical companies in Europe and Asia .
About Inivata
Inivata is the liquid biopsy specialty subsidiary of NeoGenomics Laboratories (NASDAQ: NEO). Proven InVision™ from Inivata The liquid biopsy platform unlocks critical genomic information from a simple blood draw that can be used by clinicians to guide personalized cancer treatment, to monitor treatment response and to detect relapses. The commercially available InVisionFirst™-Lung test offers highly sensitive testing and provides molecular information that allows clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata’s personalized RaDaR™ test provides highly sensitive detection of residual disease and recurrence of certain cancers and has received Breakthrough Device designation from the US FDA. Inivata works in partnership with pharmaceutical companies, biotechnology companies and commercial entities in early to late stage cancer development programs for a range of cancer types. The InVisionFirst-Lung Test and RaDaR are laboratory-developed tests (LDTs) performed by Inivata’s CLIA-certified and CAP-accredited laboratory in Research Triangle Park, North Carolina, USA. Inivata also has R&D labs in Cambridge, UK. Inivata’s technology is based on pioneering research from Cancer Research UK Cambridge Institute, University of Cambridge.
About RaDaRMT test
Inivata’s RaDaR™ test is a personalized, tumor-sensitive, highly sensitive technology that tracks a set of 48 tumor-specific variants in cell-free DNA (cfDNA) in the blood plasma of a cancer patient. Built on Inivata’s proven InVision™ platform, the custom RaDaR test was designed to detect MRD after 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 test is a laboratory-developed test (LDT) that has received Breakthrough Device Designation from the US FDA for use in the detection of MRD in early-stage cancer patients and has received CE Mark for detection of MRD and recurrence.
Forward-looking statements
This press release contains forward-looking statements. These forward-looking statements can generally be identified by the use of words such as “anticipate”, “expect”, “plan”, “could”, “could”, “could”, “will”, “believe”, “estimate”, “forecast”, “goal”, “project”, “direction”, “plan”, “potential” and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address a variety of topics, including statements regarding improved operating efficiencies, return to profitable growth and its ongoing executive search 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 Applicable risks and uncertainties include, among others, the Company’s ability to identify and implement appropriate financial and operational initiatives to improve performance, identify and recruit leadership candidates, continue to win new customers, respond to the effects of the COVID outbreak -19, propose 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 l year ended December 31, 2021 filed with the SEC on February 25, 2022 together with 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. We encourage you 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 contained 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 mentioned above. Investors, potential investors and others should pay particular attention to these risks and uncertainties.
For more information, please contact:
NeoGenomics, Inc.
Charlie Eidson
Director, Investor Relations and Corporate Development
Tel: 239.768.0600 x2726
M: 952.221.8816
[email protected]
Karen Chandler Smith
SVP Marketing and Communication
Inivata
+44 (0)7900 430235
[email protected]
Inivata Media Contacts:
Consilium Strategic Communications
Chris Gardner / Angela Gray / Genevieve Wilson
Alix Floyd (USA)
[email protected]+44 (0)20 3709 5700
THE SOURCE: NeoGenomics, Inc.
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