Research Triangle Park, NC and Cambridge, UK, September 24, 2018 -- Inivata, a leader in liquid biopsy today announces that results from its US multi-centre prospective validation study of its InVisionFirst-Lung liquid biopsy test will be presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC).
The data will be presented by the lead author of the study, Dr Ramaswamy Govindan, Professor of Medicine, at the Washington University School of Medicine, on September 25, 13.30-15.00: Prospective clinical validation of the InVisionFirst™ ctDNA assay for molecular profiling of patients with advanced NSCLC (MA16.02).
The study recruited 264 patients with untreated advanced NSCLC at 41 US centres. 178 patients had tumor tissue available for molecular profiling of at least 1 gene and the remaining 86 patients without tissue were included to compare ctDNA profiles obtained from patients with and without tissue for profiling. Tissue-based NGS testing was performed for all patients where sufficient tissue was available.
Key Results Included:
- 204 patients (77.3%) had detectable ctDNA alterations
- Overall concordance for the full 36 genes in the InVisionFirst-Lung panel with matched tissue profiling was 97.8% with 83.0% PPV, 98.5% NPV, 70.6% sensitivity and 99.2% specificity
- A subgroup of 8 genes that can influence routine clinical patient management (EGFR, ALK, ROS1, ERBB2, MET, BRAF, KRAS, STK11) the PPV was 93.7%, 96.8% NPV, 72.4% sensitivity and 99.4% specificity. Excluding patients with undetectable ctDNA, these figures become 93.7% PPV, 98.4% NPV, 87.3% sensitivity and 99.3% specificity
- ctDNA genomic profiles were consistent across patients with or without tissue
- 53.8% of patients tested with InVisionFirst-Lung had an actionable alteration or an alteration that is generally mutually exclusive for such actionable changes such as KRAS or STK11
- 26% more actionable alterations were found by InVisionFirst-Lung testing than standard of care tissue testing
Dr Ramaswamy Govindan said, “In this large-scale study, the InVisionFirst-Lung test had excellent concordance with tissue profiling and superior sensitivity and specificity. Importantly, using InVisionFirst-Lung led to the detection of 26% more actionable mutations than standard of care tissue testing, which relies on a painful, invasive procedure and can fail to provide sufficient tissue for analysis.”
Clive Morris, Chief Executive Officer at Inivata, said, “These data provide strong clinical validation for InVisionFirst-Lung and highlight its potential as a powerful means to aid treatment decisions for patients with advanced NSCLC. Importantly, the prospective clinical evaluation in unprofiled lung cancer patients characterises the performance of the test in the real-world setting facing clinicians and represents the gold standard validation of the performance of such tests.”
The company also recently announced that Palmetto GBA, a Medicare Administrative Contractor that valuates diagnostic technology through its laboratory technology assessment group, MolDx, has published a draft local coverage determination (LCD) for the InVisionFirst-Lung test. The draft LCD recommends coverage for InVisionFirst-Lung to aid clinicians in treatment decisions for CMS members fighting advanced Non-Small Cell Lung Cancer (NSCLC). The draft LCD is supported by data being presented at WCLC and was published on 13 September (see press release here).