Inivata and Collaborators Publish Clinical Validation Data for RaDaR™ Assay in Non-Small Cell Lung Cancer
Study further highlights potential of RaDaR to stratify patients and improve treatment outcomes
Research Triangle Park, NC, USA and Cambridge, UK, 17 March 2022 — Inivata, a leader in liquid biopsy, today announced the publication of new data in support of its RaDaR™ liquid biopsy test in patients with early-stage non-small cell lung cancer (NSCLC). The data from the LUng cancer CIrculating tumor Dna (LUCID) study have been published in the Annals of Oncology. The study was in collaboration with Cancer Research UK Cambridge Institute, University of Cambridge, Royal Papworth Hospital and Cambridge University Hospital.
In the LUCID study Inivata’s RaDaR minimal residual disease (MRD) and recurrence assay was used to analyze the blood samples of 88 patients with early-stage (I-III) NSCLC who had been treated with curative intent. The study found that the presence of detectable ctDNA after treatment with curative intent was highly predictive of subsequent clinical recurrence. In patients who had detectable ctDNA at a ‘landmark timepoint’ after the end of cancer treatment, both the specificity and positive predictive value (PPV) were 100%, with ctDNA detection at this timepoint being strongly predictive of both clinical recurrence (Hazard ratio 14.8) and overall survival (Hazard ratio 5.8).
Importantly, the data showed that ctDNA detection preceded clinical detection of recurrence of the primary tumor by a median of 212.5 days, highlighting the potential of the assay to identify patients who may benefit from further early therapeutic intervention. It was also found that in 30% of those patients with detectable ctDNA, the variant allele frequency was less than 0.01%, or 100 parts per million of ctDNA, underscoring the importance of highly sensitive assays for detecting residual disease and recurrence in lung cancer patients.
David Eberhard MD PhD, Chief Medical Officer of Inivata said:
“The LUCID study provides further evidence in a clinical setting of the potential of RaDaR to detect residual disease across a range of tumor types. We look forward to conducting additional studies to provide further validation of our personalized, tumor-informed assay as we move closer to its commercialization.”
Professor Robert Rintoul FRCP PhD, Clinical Study Lead, University of Cambridge and Royal Papworth Hospital, Cambridge, commented:
“There is a growing body of evidence for the utility of ctDNA testing in the detection of residual disease and recurrence. We believe there is potential for highly sensitive MRD assays such as RaDaR to transform the cancer treatment landscape by identifying patients at high risk of relapse who may benefit from additional therapy, whilst avoiding unnecessary treatment for low-risk patients.”
Inivata is the liquid biopsy focused subsidiary of the NeoGenomics, Inc (NASDAQ: NEO) Group. Inivata’s InVision® liquid biopsy platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. The personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence and has been granted Breakthrough Device Designation by the US FDA. The commercially available InVisionFirst®-Lung test offers best-in-class sensitivity and turnaround and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs across a range of cancer types. Inivata has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.
RaDaR is Inivata’s assay for the detection of minimal residual disease (MRD) and recurrence. Built on Inivata’s proven InVision® liquid biopsy platform technology, RaDaR is a highly sensitive personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy, allowing both detection of residual disease following curative intent or definitive treatment and early detection of relapse. RaDaR has been granted Breakthrough Device Designation by the US FDA.