On November 17, 2020 NantHealth, Inc. (NASDAQ: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported the publication of a study that revealed RNA sequencing is not only viable but may also provide significant clinical value in analyzing a cancer patient’s specific disease biology to enable an optimized treatment decision with a higher likelihood of success (Press release, NantHealth, NOV 17, 2020, View Source [SID1234571228]). The study was published in Nature’s Scientific Reports, an open access, peer-reviewed journal dedicated to original research from across all areas of the natural and clinical sciences.
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Prepared in collaboration with NantOmics, LLC and ImmunityBio, Inc., the study was designed to explore the potential use of formalin-fixed paraffin-embedded (FFPE)-derived RNA transcriptome profiling for clinical decision-making. This technique was previously not considered to yield significant clinical value due to the lower quality, degraded samples typically produced by the formalin fixation process. FFPE is the most common method used in clinical settings for storing tumor biopsies.
The study revealed an overall sequencing success rate of 81% with highly consistent coverage in direct FFPE and fresh-frozen (FF) replicates (98% agreement). The results provide strong rationale for the use of FFPE-derived RNA sequencing in clinical decision-making based on the reproducibility, robustness, and consistency of whole transcriptome profiling. This research enables the comparison of clinical samples to research studies, which generally differ in both data collection and sequencing methods, and which may unlock highly valuable insights that would not be possible with DNA sequencing techniques alone.
"This is an important step to advancing towards molecularly informed medicine, both from the perspective of diagnostics to precise therapeutic intervention," said Dr. Patrick Soon-Shiong, CEO of NantHealth, NantOmics and ImmunityBio. "Genomic reporting capabilities could be enhanced through clinical applications resulting from this technology, including identifying cancers of unknown primary (CUP), prevalence of immune cell infiltrates in the tumor microenvironment (immunome), and expression analysis of checkpoint markers including those targeted by commercial and investigational immunotherapies," he continued.
The study also demonstrates that RNA sequencing is not only clinically viable but valuable and can provide a more thorough understanding of what genes are driving each individual patient’s tumor to better inform personalized treatment decisions.
To achieve this, researchers performed ribo-deplete RNA extractions on more than 3,200 FFPE slide samples to measure the expression of clinically significant genes that help identify treatments with the highest likelihood of response. The study included a comprehensive evaluation of RNA extraction methods (Poly-A and ribo-depletion) by comparing transcriptomes from The Cancer Genome Atlas (TCGA) cohort and 3,116 FFPE samples. Findings showed minimal differences between the two approaches within clinically important genes, while establishing a computational framework for comparing the expression of FFPE clinical samples to the growing database of research samples generated by academic studies.
"These are very exciting results from a robust scientific study of a high caliber," said Shahrooz Rabizadeh, Ph.D., Chief Scientific Officer, ImmunityBio. "The implication of using RNA sequencing to molecularly define a patient’s cancer, identify the origin of cancers of unknown primary, and most importantly, optimize treatment plans for the highest chance of success, especially with immunotherapies, is profound."
"Through this research, we demonstrated the robustness of the RNA assay and the informatics techniques that help clinicians understand the transcriptional drivers of disease in their patients, allowing the further advancement of personalized medicine," said Dr. Sandeep "Bobby" Reddy, Chief Medical Officer, NantHealth. "NantHealth knows that high-quality data is the backbone of modern medicine. This study unlocks valuable insights through a method that allows the analysis of both academic research and clinical data for treatment optimization, further strengthening our fight against cancer."
Receiving widespread attention in policy documents and the media, Scientific Reports is the seventh most-cited journal in the world, with more than 350,000 citations. The publication has an extensive network of expert peer reviewers and an editorial team who provide rigorous and objective review. Scientific Reports is guided by the same ethical and editorial guidelines as other Nature Research publications to ensure that all the research is original, scientifically robust and of the highest quality. The journal is published through a number of different channels, including nature.com, where it receives approximately two million monthly visitors.