Enhance Sensitivity of Mutation-Detection by EFIRM with a Saliva Preservative Solution (UCLA Case No. 2023-101)

UCLA researchers led by Prof. David T. Wong of the School of Dentistry have developed a breakthrough in noninvasive cancer diagnostics, combining the Spectrum Saliva Collector (SDNA-1000) with a preservative solution and cutting-edge Electric Field-Induced Release and Measurement (EFIRM) technology for sensitive, rapid detection of EGFR mutations in saliva. EGFR mutations are critical biomarkers for targeted therapies in non-small cell lung cancer (NSCLC), making timely and accurate mutation detection essential for personalized patient care.

Innovation:

• Noninvasive Sample Collection: Leveraging saliva as a diagnostic medium offers a patient-friendly alternative to tissue biopsies or blood draws. The SDNA-1000 collector preserves the integrity of circulating tumor DNA (ctDNA) in saliva, ensuring stable and reliable samples even during transport.
• EFIRM Technology: The electric field-induced release mechanism selectively liberates ctDNA from saliva, enabling a streamlined electrochemical measurement with high sensitivity and specificity. This removes the need for complex DNA extraction or amplification steps, reducing assay time and complexity.
• High Concordance and Clinical Reliability: Proficiency testing highlights strong agreement between EFIRM-based saliva assays and tissue biopsy genotyping, supporting the clinical validity of this approach for mutation profiling.

Advantages:

• Rapid and Accurate Mutation Detection: Enables early identification and dynamic monitoring of actionable EGFR mutations, facilitating faster therapeutic decisions and personalized treatment adjustments.
• Cost-Effective and Scalable: The simplified sample collection and processing reduce operational costs and barriers to widespread adoption, supporting high-throughput testing regimes in hospital and outpatient settings.
• Enhanced Patient Compliance: The painless saliva collection improves patient willingness for serial sampling, allowing for real-time monitoring of disease progression or therapy resistance without invasive procedures.
• Enables Decentralized Testing: The stability of samples collected with SDNA-1000 allows for remote collection and transport, expanding access to molecular diagnostics in diverse clinical and geographic settings.

Market Potential: With the NSCLC patient population growing and precision oncology becoming standard-of-care, this platform is ideally positioned to capture market share in liquid biopsy diagnostics. The Spectrum Saliva Collector combined with EFIRM detection technology sets a new standard for noninvasive, reliable, and scalable mutation profiling in lung cancer, poised to transform patient management and drive innovation in precision oncology diagnostics.

Related publications (from inventors only):

Li F, Wei F, Grogan TR, Elashoff DE, Vu D, Vigerust DJ, Gupta R, Wong DTW. Proficiency Testing of Epidermal Growth Factor Receptor Mutations Detection in Saliva Using Spectrum Saliva Collector (SDNA-1000) and Preservative Solution Detected by Electric Field-Induced Release and Measurement. Biopreserv Biobank. 2022 Oct;20(5):461-464. doi: 10.1089/bio.2022.0093. Epub 2022 Jul 26. PMID: 35878053; PMCID: PMC9603249.