New data on liquid biopsy genomic tests, including multiplexed genomic assays; evaluation of biological processes underlying mass spectrometry proteomic assays of human serum
April 5, 2017, Boulder, Colorado… Biodesix is presenting three studies that support the company’s multi-omic capabilities and provide insight into the biology of classifiers developed with Deep MALDI™ mass spectrometry and the Diagnostic Cortex™ machine learning platform. The studies are being presented at the AACR Annual Meeting in Washington, DC.
“The new data demonstrate Biodesix’s multi-omic approach to answering clinically relevant questions,” said David Brunel, Biodesix CEO. “We have consistently proven our ability to develop blood-based assays that can be transferred into a CLIA setting quickly given our highly standardized and reproducible methodologies.”
In the study, “Development of scores reflective of biological processes underlying human disease states from mass spectrometry of serum,” protein set enrichment analysis (PSEA) was combined with principal component analysis (PCA) to create mass spectrometry-derived scores for assessing several biological processes that may be relevant to human cancers. Scores were created for acute response, complement and wound healing. The scores are correlated with survival and, while preliminary, could lead to a better understanding of disease processes and provide the basis for novel clinical diagnostics, including therapy monitoring tests.
“Utility of a targeted NSCLC genomic test for cfDNA variants in the community setting” reviewed results from more than 6,000 individual patient cases (assessing approximately 44,000 individual variants) to determine the utility of a blood-based, cell-free DNA laboratory-developed test (LDT) in the community setting. The GeneStrat® test, which utilizes droplet digital PCR (ddPCR) to detect clinically actionable genetic aberrations in non-small cell lung cancer (NSCLC), provided patient mutation status results within 72 hours of sample receipt in 96% of cases. Test results were generated successfully for 98% of patient samples submitted. Among the 5,199 cases for which practice information was available, more than 80% of sites were community-based.
In the study “Early Feasibility and Development of Multiplexed, Single-Reaction Assay for ALK, ROS1 and RET Novel ddPCR RNA Fusions,” the addition of these new assays to the GeneStrat liquid biopsy test are reviewed, including a report on RNA fusion test performance. The blood-based RNA tests simultaneously measure 78% of EML-4-ALK, 88% of ROS1, and 99% of RET fusion transcript variants in NSCLC. A blood-based PD-L1 RNA test is also under development.
The posters are available in the Lung section of Publications and Posters at Biodesix.com.
Biodesix® is a molecular diagnostics company advancing the development of innovative, multi-omic blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic liquid biopsy tests, including the GeneStrat® and VeriStrat® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests and with the Biodesix Lung Reflex™ testing strategy, for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of personalized medicine, Biodesix is developing new tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.