publication date: Apr. 26, 2019
Inivata shows positive clinical validation results and real-world utility for its InVisionFirst-Lung liquid biopsy test
Inivata conducted two prospective, multi-center studies in collaboration with 41 key institutions across the United States. The data, published in JCO Precision Oncology, highlights the potential of Inivata’s first Medicare-reimbursed commercial test to improve delivery of comprehensive tumor genomic profiling.
The publication follows the presentation of these data at the World Conference on Lung Cancer in September 2018.
The studies recruited 264 advanced NSCLC patients and compared the genomic profiling performance of InVisionFirst-Lung versus standard-of-care tissue testing.
The studies showed that Inivata’s liquid biopsy test demonstrated excellent concordance with tissue profiling, with a high level of sensitivity and specificity. Notably, the InVisionFirst-Lung liquid biopsy test was able to detect 26% more actionable alterations versus standard-of-care tissue testing. More comprehensive testing with InVisionFirst-Lung could lead to more accurate patient stratification and potentially to improved outcomes based on more personalized therapy.
Two prospective multi-center clinical validation and utility studies were conducted enrolling 264 advanced untreated NSCLC patients.
Tumor tissue-based genotyping was available in 178 patients for comparison to plasma profiling. The remaining 86 patients were included to compare ctDNA profiles across patients with and without tissue for profiling.
Considering specific alterations in the eight clinically relevant genes that most influence patient management in advanced NSCLC, sensitivity was 73.9% with 99.8% specificity; 97.8% PPV and 97.1% NPV.
Overall concordance of InVisionFirst-Lung with matched tissue profiling was 97.8%, 70.6% sensitivity and 99.2% specificity with 82.9% PPV, 98.5% NPV.
The studies support the hypothesis that InVisionFirst-Lung has clinical utility in over 50% of patients in untreated advanced stage NSCLC, … Continue reading Inivata shows positive clinical validation results and real-world utility for its InVisionFirst-Lung liquid biopsy test
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