Solid Tumor Mutation Detection Panel
Our plasma-based solid tumor mutation panel covers 26 of the most important genes and 1000 associated mutations in the most significant pathways of cancer, including EGFR/MAPK and PI3K. The panel utilizes our unique exosome-based technology platform to simultaneously isolate and analyze exosomal RNA (exoRNA) and cell-free DNA (cfDNA), two biologically distinct sources of circulating nucleic acids. Combining exoRNA and cfDNA in a single step enables our panel to achieve ultra-sensitive detection of rare cancer mutations. The panel is a Laboratory Developed Test (LDT) analyzed at our certified CLIA laboratory and will be available as a clinical development tool for pharma companies in 2016.
- Analyzes stable, high-quality exoRNA plus cfDNA for highly sensitive mutation detection
- Covers 26 of the most important genes and 1000 associated mutations
- Detects most actionable mutations with clear clinical relevance; EGFR/MAPK and PI3K pathways
- Eliminates need for tissue samples as a plasma-based test
- Enables rapid eligibility identification and patient stratification for clinical trials
- Allows longitudinal and serial molecular monitoring throughout the clinical trial process
- Can utilize fresh or frozen/archived plasma samples
- Does not require special shipping or storage provisions
- Employs expert analysis from CLIA-certified lab
In a study presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, our liquid biopsy panel for solid tumors demonstrated the ability to provide robust, highly sensitive detection of actionable mutations, including KRAS, BRAF and EGFR, across multiple cancers such as melanoma, colorectal cancer, and lung cancer.
Utilizing the combined capture of exoRNA and cfDNA from plasma, the panel’s technology substantially increased the number of gene copies available for low abundant somatic mutation detection versus cfDNA alone, helping ensure that the mutation would not be missed or overlooked. In the BRAF-specific data, the technology platform enabled longitudinal monitoring of BRAF mutant melanoma and demonstrated the ability to detect early disease progression prior to clinical evidence or radiographic changes.