SBIR Phase I: Ultra-sensitive Detection of Lipoarabinomannan (LAM) and Interferon-Gamma (IFN-g) as Biomarkers for Detection of Tuberculosis (TB)

Plasmonic Diagnostics Llc, Columbia MO

Investigators

Abstract

This SBIR Phase I project is intended to develop a noninvasive, ultra-sensitive molecular detection system for Tuberculosis (TB). Although the prevalence of TB has diminished, it still remains the second leading cause of death from an infectious disease. The latest global TB report from the World Health Organization with data compiled from 205 countries put the figures at 1.5 million fatalities and 9.6 million infections annually. The proposed technology uses the nano- Plasmonic Grating (P-GRAT) properties to enhance the detection signal of the TB biomarker by more than 100X. This results in detecting concentrations in femto-gram/milliliter range resulting in early detection and treatment. The specificity, faster results, low cost/test and ease of use, makes this system a substantive innovation in the TB diagnostic market. The TB testing market accounts for $1.5 billion annually of which North America is the second largest in terms of generated revenue due to the higher pricing for TB detection. The proposed technology will benefit the patients with early diagnosis and provide the health care professionals with early treatment options. With all the advantages this technology has to offer, it is expected to gain a significant share in the market place and generate a revenue stream. The main limitation of the immunoassays is their inability to detect extremely small fluorescence signals that are associated with ultra-low concentrations of biomarkers. The proposed nano- Plasmonic Grating (P-GRAT) technology can overcome this limitation due to its exceptionally efficient light coupling, reduced scattering, high signal-to-noise ratio and directional excitation/emission. As a result, a fluorescence enhancement of P-GRAT is 100X or higher compared to a glass substrates or polyurethane well plates. Such enhancements translate to ultrasensitive detection and early diagnosis. Commercial immunoassays require hours to days to achieve pg/ml sensitivity. In comparison, P-GRAT can detect pg/mL range concentrations in less than three hours. P-GRAT utilizes a simplified design to exclude expensive optics like laser sources, high-magnification objective lenses and filter cubes. The use of 3-D printed parts to fabricate the system and use a smartphone as the detector further reduces the cost. We intend to develop and commercialize a noninvasive, ultra-sensitive (fg/ml) molecular detection system for Tuberculosis (TB). TB specific biomarkers Lipoarabinomannan (LAM) and Interferon gamma (IFN-g) will be detected in urine and saliva. P-GRAT is a platform technology and can easily be adapted for the ultra-sensitive detection and diagnosis of other diseases, such as Zika, Ebola, HIV and Cancer. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.