Inivata to Present Data at AACR Virtual Annual Meeting Highlighting Capabilities and Clinical Application of RaDaR™ Assay


Inivata to Present Data at AACR Virtual Annual Meeting Highlighting Capabilities and Clinical Application of RaDaR™ Assay

Personalized assay for detection of residual disease and recurrence demonstrates exceptionally high sensitivity and specificity – 97% sensitivity and 100% specificity at 20ppm

In a real-world clinical setting based on provisional clinical data from early stage NSCLC patients, RaDaR detected ctDNA 6-12 months ahead of clinical progression in the majority of cases and ctDNA detection was associated with lower progression free survival

Research Triangle Park, NC, USA and Cambridge, UK, 22 June 2020 -- Inivata, a leader in liquid biopsy, will present data at the American Association for Cancer Research (AACR) Virtual Annual Meeting II in support of the capabilities and real-world application of the Company’s newly launched RaDaR™ assay.

RaDaR is a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity, allowing both detection of residual disease following curative intent or definitive treatment, and early detection of relapse. The assay thereby offers promise for patients who are at higher risk of relapse who may benefit from adjuvant therapy.

Inivata will present data from the analytical development of RaDaR, which shows the ability to detect circulating tumor DNA (ctDNA) at 20 parts per million (0.002% allele fraction) with 97% sensitivity and 100% specificity. The panel design of ≤ 48 variants is robust across multiple tumor types, indicating its practicality in a real-world setting.

Further data will be presented from a clinical setting, which demonstrates RaDaR’s sensitive detection of ctDNA in early-stage non-small cell lung cancer (NSCLC). Samples were taken from a real-world clinical cohort of 90 patients with early-stage NSCLC who underwent treatment with curative intent and of whom 61% had stage I disease.

Provisional clinical data gathered from the study shows that RaDaR was able to detect ctDNA at baseline or follow-up in 71.9% of the cohort and at as little as 6ppm (0.0006% allele fraction). In patients who progressed, ctDNA was detected between 6 - 12 months ahead of progression in the majority of patients assessed, with ctDNA detection post-treatment showing an association with lower progression-free survival compared to patients in the ctDNA negative group.

Clive Morris, Chief Executive Officer of Inivata, commented: “Sensitivity is a key factor for effective liquid biopsy technologies for the detection of minimal residual disease and relapse. These data demonstrate that our approach, which uses a 48-variant panel, allows for exceptional sensitivity and specificity. To have also demonstrated RaDaR’s potential to highly sensitively detect ctDNA up to a year ahead of clinical progression in a very challenging real-world patient cohort gives us even greater confidence in its utility for the better development of cancer therapies and ultimately for improving patient care.”

The data will be presented in two poster sessions, which are available to view via the AACR e-poster site, together with audio descriptions:

Title: Sensitive detection of ctDNA in early stage non-small cell lung cancer patients with a personalized sequencing assay
Session: PO.CL11.08 - Circulating Markers 1
Timing: 22 June, 9.00am - 6.00pm EDT
Poster No: 735
Link to poster

Title: Analytical development of the RaDaR™ assay, a highly sensitive and specific assay for the monitoring of minimal residual disease
Session: PO.CL11.10 - Circulating Markers 3
Timing: 22 June, 9.00am - 6.00pm EDT
Poster No: 3097
Link to poster

About Inivata
Inivata is a leader in liquid biopsy. Its InVision® 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. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR™ assay – allowing the highly sensitive detection of residual disease and recurrence. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to Follow Inivata on Twitter @Inivata.

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