NEW YORK – The Princess Margaret Cancer Centre will use Inivata's InVisionFirst-Lung and RaDaR liquid biopsy assays in two clinical lung cancer studies, in a collaboration announced by Inivata Tuesday.
The Accelerating Lung Cancer Diagnosis through Liquid Biopsy, or ACCELERATE, study will compare the time it takes for patients to begin treatment for non-small cell lung carcinoma following diagnosis via liquid biopsy versus the more conventional diagnostic pathway of molecular testing of tumor tissue after imaging and biopsy.
The InVisionFirst-Lung next-generation sequencing assay tests 37 NSCLC-relevant genes found in circulating tumor DNA. The single-arm, prospective study will evaluate how well the assay speeds time to treatment for patients awaiting diagnostic tissue biopsy and molecular profiling results. Recruitment has begun and the collaborators hope to enroll up to 150 patients with advanced NSCLC over the next 12 months.
In the second study, called ctDNA Lung, Princess Margaret researchers will use Inivata's RaDaR assay to identify curative therapy candidates following lung cancer resection via signs of minimal residual disease.
This trial will take place in two phases, called DETECT and RCT. In the initial DETECT phase, RaDaR will be used to screen 360 early-stage lung cancer patients, assessing their pre- and post-operative ctDNA levels. From this cohort, 66 participants with ctDNA levels detected three to six weeks post-operatively will be selected for the randomized controlled trial, or RCT, phase, which will investigate the benefit of administering adjuvant therapy with chemo-immunotherapy.
InVisionFirst-Lung consists of a 37-gene panel that identifies single nucleotide variants, copy number variants, and gene fusions. RaDaR assays for 48 mutations relevant to MRD monitoring.
Neogenomics recently acquired Inivata with the goal of using its liquid biopsies to break into the MRD monitoring market.
"Liquid biopsy technologies have the potential to transform cancer treatment, getting patients to the right treatment faster and increasing the chances of a cure," Natasha Leighl, lung site lead for medical oncology with Princess Margaret, said in a statement. "We look forward to working with Inivata on these important studies."