Research Triangle Park, NC, USA and Cambridge, UK, 21 June 2022 -- Inivata, a leader in liquid biopsy, announces new data in support of its RaDaR™ assay for the detection of minimal residual disease (MRD) and recurrence in patients with high-risk hormone receptor–positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) 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), has been published in the Journal of Clinical Oncology and was presented in part at the 2022 ASCO® Annual Meeting which took place 3-7 June 2022 in Chicago, IL.

In collaboration with the Dana-Farber Cancer Institute, the AstraZeneca supported study used Inivata’s RaDaR personalized MRD assay to examine ctDNA and its association with metastatic recurrence in patients with high-risk, early-stage HR+ HER2- breast cancer at least five years after diagnosis – when over half of metastatic recurrences are known to occur.

The RaDaR assay used patient-specific primer panels to analyze ctDNA in blood samples of the 83-patient cohort.   Samples were collected every 6-12 months, starting at a median time of 8.4 years (range, 4.9 – 20 years) after initial diagnosis, and followed for clinical tumor recurrence. Median follow-up time was 2 years from the first blood sample.

Ten percent of the patients had positive MRD results during the study. In all 6 cases of distant metastasis in the cohort, ctDNA was previously identified using the RaDaR assay with a median lead time of one year. None of the patients with positive MRD testing – which included an additional two patients who have not yet experienced recurrence – had known metastatic recurrence at the time of first plasma sample.

The data highlight the potential of the RaDaR assay to provide an early predictor of tumor recurrence which, in turn, may allow for earlier intervention, and demonstrates that tumor-informed ctDNA assays can be used successfully several years after diagnosis and treatment of the original tumor.

David Eberhard MD PhD, Chief Medical Officer at Inivata, commented: “To our knowledge, this is the first data to be released on plasma ctDNA analysis for MRD detection in late adjuvant HR+ breast cancer patients, building on our existing evidence base in breast cancer as well as 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 in informing the 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 demonstrate how important targeting multiple variants using an individualized assay, such as the RaDaR assay, can be in identifying MRD-positive patients. It is exciting to see this data highlighting the promise of this method and I am hopeful that, with further studies, earlier detection of disease may enable earlier intervention and more positive outcomes for patients at greater risk.”

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About Inivata
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 RaDaR™ 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.