Technology Overview Giner, Inc. (Giner) has developed a low-cost, portable instrument for detection of toxins found in seawater during harmful algal blooms (HABs). During these HAB events the rapid growth of Karenia brevis algae leads to a significant increase in local concentrations of a marine neurotoxin, brevetoxin (BTX). High density blooms of K. brevis, “red tides”, are endemic to the Gulf of Mexico and frequently occur on a nearly annual basis. Giner’s field-ready toxin analyzer, developed with NOAA SBIR Phase II funding, uses aptamer modified screen printed electrodes (SPEs) to bind with brevetoxin present in ocean water. This is followed by a rapid electrochemical analysis step to elucidate toxin concentrations. The resulting assay is portable and more cost efficient than traditional methods but has a similar limit of detection, making it possible for use as a red tide early warning tool. This novel assay has been incorporated into a custom prototype handheld device that performs the electrochemical detection step and data recording either locally or by Bluetooth using a nearby tablet or laptop computer. The complete instrument can be easily carried and used along the Florida coastline to better detect and monitor the severity of HAB events. Advantages Traditional benchtop instruments (i.e. HPLC-MS) used to measure brevetoxin are bulky, expensive, and they require skilled technicians to operate. Sample-to-result turnaround time is, at best, on the order of hours but typically requires several days. The health and economic effects of a red tide on nearby communities are exacerbated by this delay. Additionally, samples need to be collected, transported, and sometimes stored at the testing facility prior to analysis, creating several logistical hurdles for those performing the analysis. Conversely, ELISA or other antibody based immunoassay techniques are more accessible while performing field work, but they lack the sensitivity and selectivity of traditional chromatography techniques. These assays also necessitate a cocktail of complex reagents that do not store or travel well. Giner’s electrochemical toxin assay and the analyzer instrument would provide HAB researchers and public health officials with several advantages over the current state of the art toxin monitoring. The aptamer functionalized SPEs are inexpensive, easy to fabricate and can be stored for months before use. Testing is rapid (<30 min sample-to-result) and inexpensive (<$15/sample). Lastly, the parts-per-billion level limit of detection can alert officials to a red tide event far before the current visual methodologies of beach observation and satellite imagery. Partners Florida Map with MOTE Beach Conditions Reporting Sites (Credit: MOTE Marine Lab) Through the NOAA Phase II funding, Giner was able to partner with Mote Marine Laboratory (Mote), based in Sarasota, FL, to guide development of the sensor to better fit the needs of potential end users. Giner worked closely with Dr. Richard Pierce (Senior Scientist for Ecotoxicology at Mote) who provided valuable insight on red tide ecology as well as the necessary K. brevis lab work. This collaboration has subsequently led to several other HAB related partnerships, including adaptation of Giner’s technology to detect aerosolized brevetoxin found in ocean spray to monitor respiratory health concerns for communities adjacent to Florida’s coastal regions. By leveraging Mote’s Beach Conditions Reporting System (BCRS), Giner’s rapid aerosol toxin data would feed into the daily reports of red tide conditions (e.g. respiratory irritation, dead fish, and discolored waters). Giner’s goal is to distribute a handheld portable instrument to trained beach sentinels (lifeguards, government agents, and vetted volunteers) to improve airborne detection and data resolution. The BCRS has become a staple for residents and visitors, acquiring over 1 million users and over 4 million page views to the website alone. Data from this effort is also automatically sent to GCOOS, NOAA, and FWC. Federal Procurement Information The right to receive sole-source awards is a real benefit of the SBIR Program both to the government and to the participating companies. The SBA SBIR/STTR Policy Directive dictates the justification that an agency can and must use to justify the sole-source award. Predictably, that justification reads that the new award must derive from, extend, or complete prior SBIR effort and be funded with non- SBIR funds. For inquiries about this technology, please contact Giner, Inc. directly.