AACR 2020 Summary: Demonstrating a sensitive and specific personalized assay to detect residual disease and recurrence

BY CLIVE MORRIS
Like many other recent events, this year’s annual meeting of the American Association for Cancer Research (AACR) was converted into an entirely virtual experience focused on clinical data as a result of the COVID-19 pandemic. For Inivata, this meant that we were still able to present two posters sharing exciting provisional data around our recently launched personalized RaDaRTM 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. This enables the detection of residual disease in a patient following curative intent or definitive treatment, as well as any signs of early relapse. With RaDaR we have taken the same principles of extreme sensitivity and specificity and translated these into an individual assay for each patient. This offers promise for patients who are at a higher risk of relapse and who may benefit from adjuvant therapy.

Exceptionally high sensitivity (97%) and specificity (100%) at 20ppm
The first poster that we presented at AACR highlighted technical data from the analytical development of RaDaR. The data shows the ability of the assay to detect circulating tumor DNA (ctDNA) at 20 parts per million (0.002% allele fraction) with 97% sensitivity and 100% specificity.

ctDNA detected in 71.9% of early stage NSCLC cohort
The second poster shared provisional data describing how our assay performed in a real-world clinical setting when detecting ctDNA in early-stage non-small cell lung cancer (NSCLC). Samples were taken from 90 patients who had received treatment with curative intent, 61% of whom had stage I NSCLC. Of course, the lower the tumor burden, the less ctDNA in the blood and hence the need for RaDaR to demonstrate exceptionally high sensitivity. After producing 90 personalized panels for these patients, we showed ctDNA detection at baseline or follow-up in 71.9% of the cohort and at as little as 6ppm (0.0006% allele fraction).

ctDNA detected 6-12 months ahead of clinical progression in the majority of cases
In patients who progressed and where samples were available, ctDNA was detected between 6 – 12 months before clinical progression in the majority of patients assessed.

These data demonstrate that our approach, using a 48-variant panel, provides exceptional sensitivity and specificity. They also highlight RaDaR’s potential to detect ctDNA in a very challenging real-world patient cohort. Ultimately, this gives us confidence in our technology and its ability to enable physicians to make informed decisions on patient treatment and care.

Both posters are available on our website under publications

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