Overview
Low-dose computed tomography (LDCT) is recommended for annual screening by the US Preventive Services Task Force, and the test is reimbursed by Medicare (see below). LDCT is intended for early detection of cancer, but unfortunately has a high false-positive rate (i.e., it detects indeterminate pulmonary nodules (PNs), 96% of which are ultimately benign). Following a positive LDCT screen, patients are subjected to additional procedures, some of which are invasive and expensive (e.g., PET, MRI, transthoracic needle and/or transbronchial biopsies) to confirm the nature of the PNs. In an effort to address the inadequacies of LDCT screening, UMB researchers developed a new lung cancer diagnostic panel and algorithm, which incorporates key biomarkers and other patient data. Specific sncRNA biomarkers were identified from sequence analysis of early-stage lung tumors and matched controls, and an integromic signature combines different categories of biomarkers to further enhance the assay results. UMB’s lung cancer diagnostic panel has been performed on hundreds of patient samples, and demonstrates the ability to precisely distinguish malignant from benign PNs with high sensivity and specificity. One feature that enhances the precision of UMB’s method is the use of droplet digital PCR (ddPCR) for the quantification of nucleic acid. This analysis of lung tumor-associated molecular changes in plasma &/or sputum provides a liquid biopsy for safely and cost-effectively detecting early-stage lung cancer.
Applications
In the USA, more than 43.4 million smokers (ages 55-74 years) are eligible for LDCT lung cancer screening. Of these, more than 10.8 million (25%) will receive a positive LDCT diagnosis without a clear indication of lung cancer. The cost of LDCT is ~ $240/person/year and yearly screenings are now covered by Medicare (Pyenson et al. 2014, Am Health Drug Benefits). Other academic groups have developed predictive algorithms, which rely on multiple patient data for input variables, but these methods do not approach the high sensitivity and specificity of UMB’s diagnostic panel.
Advantages
- Robust method, using patient-specific data and liquid biopsy samples (plasma &/or sputum) to detect biomarkers in various categories (e.g., miRs, lncRNA, FUT)
- Higher sensitivity and specificity than current methods
- Promising as a complementary test to differentiate LDCT-positive patients and focus care on those who need it
Stage of Development
- Translational research is underway to adapt UMB’s lung cancer diagnostic panel to reliably perform as a Laboratory Developed Test in a CLIA setting.
(NC- 2/7/19)
Licensing Potential
Available for licensing & sponsored research
Contact Info
Office of Technology Transfer
620 W Lexington St., 4th Floor
Baltimore, MD 21201
Email: [email protected]
Phone: (410) 706-2380