Claret Bioscience LLC — Department of Health and Human Services SBIR Phase I: 102

Description

SummaryClaret Bioscience is developing a next generation sequencingNGSlibrary preparation technique that can be deployed as a liquid biopsy DNA assayLiquid biopsy recovers biomarkers like DNA and other cellular material found circulating in the blood and other bodily fluidscalled cell free DNAcfDNAIn individuals with tumorsa small portion of the overall cfDNA will derive from the cancerous cellssharing somatic variants with the tumor itselfLiquid biopsy thus promises a noninvasive means of detecting and genotyping a patientandapos s solid tumorHoweverthere are few cfDNAbased assays approved today for clinical diagnostic useThey are restricted to relatively few known cancer driving variantslimiting the scope of cancer screening and the utility of high throughput sequencersClaretandapos s solution is an NGS liquid biopsy assay that aims to broadly and agnostically identify DNA of abnormal originOur high throughput assay exploits a novel cfDNA biomarker by recovering and charactering signals of DNA degradation found only at the termini of cfDNA fragmentsThe major potential outcome of our technology is a liquid biopsy tool that is additiveproviding valuable cfDNA sequence data while simultaneously exploiting biologically degraded fragment endsinformation lost to all NGS methods to dateThe technical challenge of bringing our innovation to the NGS and or liquid biopsy market hinges on two central challengesFirstthe assay must efficiently convert a pool of cfDNA molecules into a sequencing library with high fidelity such that the actual DNA molecular ends are capturedOur first Phase I goal is thus assay optimizationWe will measure fidelityefficiencyreproducibilitysensitivity using a series of experimentally designed synthetic controlsThe second challenge is to discern the biological utility of the characterization of cfDNA terminiWe designed our second aim of Phase I to probe for specific signals that may be indicative of disease state and assayable from cfDNAWe focus on matched setstissue diseasedtissue normalblood plasmaof clinical samples from treatment na ve donors with known cancer typesThe proposed Phase I proof of concept experiments and assay optimizations will yield a path to a commercially viable product capable of revealing important patterns of DNA degradation from healthy and diseased samplesProject Summary! Narrative Liquid biopsy recovers biomarkers like DNA and other cellular material found in the blood and other bodily fluidsIn individuals with tumorsa small portion of the overall cell free DNAcfDNAwill derive from the cancerous cellsAs suchnew approaches to investigate cfDNA via liquid biopsy hold extreme promise for noninvasive biomedical discoveryThis is especially true in oncology where the intractability of surgical tumor biopsiesserial or otherwisehinders early detectionmonitoring of treatment and tracking disease progressionClaret Bioscience has developed a next generation sequencing tool that exploits the unique signals of DNA breakdown for each individual cfDNA molecule in real timeThe mission is to deploy this technology as a high throughput liquid biopsy assay for clinical use in the evaluation of broad cancer detection and monitoring! Project Narrative