Inivata has announced positive results from the prospective clinical study of its RaDaR liquid biopsy test in patients with head and neck squamous cell carcinoma (HNSCC).
The Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS) study was conducted in partnership with the Ludwig Maximilian University (LMU) Klinikum, Department of Otorhinolaryngology, Head and Neck Surgery (ORL-HNS) as well as the LMU Munich, Institute of Pathology, Faculty of Medicine.
Blood samples from 17 stage III-IVB, p16-negative HNSCC patients, who received curative-intent primary surgical treatment, were collected for the LIONESS study.
These samples were tested using RaDaR for detecting circulating tumour DNA (ctDNA) for minimal residual disease (MRD) and evidence of the recurrence of the disease pre- and post-surgery.
RaDaR is a multi-tumour, personalised assay, which is designed to track up to 48 tumour-specific variants using a liquid biopsy.
The company stated that all the patients in the study had detectable ctDNA before the surgery.
ctDNA was detected before disease progression in all five patients with clinical recurrence.
The remaining 12 patients had no recurrence and indicated a 100% clinical specificity of the RaDaR assay.
Inivata chief medical officer David Eberhard said: “These data further highlight the clinical utility of our RaDaR assay in the detection of minimal residual disease across tumour types.
“The assay showed exceptionally high sensitivity, detecting ctDNA in every HNSCC patient who went on to recur, which along with its specificity demonstrates the potential of RaDaR to identify HNSCC patients at an increased risk of relapse, enabling earlier intervention and personalised therapy planning.”
Last May, NeoGenomics agreed to exercise an option for the acquisition of Inivata.