SBIR-STTR Award

MBio Diagnostics is developing a highly sensitive, inexpensive, easy-to-use test system that will allow growers and regulators to more tightly manage shellfish harvests before, during, and after HAB blooms (see Figure 1). The Interstate Shellfish Sanitation Conference (ISSC) is a primary industry/regulatory cooperative body in the United States, tasked with fostering and improving the sanitation of shellfish through interstate cooperation and through uniformity of state shellfish programs. One of ISSC's stated research priorities is the development of field deployable, rapid, inexpensive screening methods for the analysis of "all toxins and for each commercially-harvested bivalve species [25]." The technology proposed in this Phase I USDA SBIR is designed to address this need. This new technology will enhance the technology base necessary for the expansion of the domestic aquaculture industry. MBio Diagnostics is developing a transformative platform technology that will enable users in the field to perform cost-effective, multiplexed, rapid, laboratory-quality HAB toxin testing. Here, we propose to use this platform technology for the multiplexed, rapid measurement of STX, DA, and OA in shellfish meat. Per tests costs for the multiplexed cartridges are expected to be less than the ~$20 associated with currently available dipstick tests, and we target a reader cost of several hundred dollars. The assay sensitivities will be tuned to match the regulatory limits for these toxins. This technology will protect the safety of the nation's food supply while enabling expansion of aquaculture by reducing the time and cost necessary to bring shellfish to market.

MBio Diagnostics is proposing to develop a portable rapid inexpensive technology for more effective detection of harmful algal bloom (HAB) toxins in shellfish. The proposed product will help producers and managers get more product to market while ensuring the safety of this commercially important food supply during HAB events. Shellfish are filter feeders and can accumulate HAB toxins during blooms. These toxins can cause serious health effects including temporary paralysis intestinal or respiratory distress or even death. Shellfish harvest closures due to HAB toxins are required to protect public health. Current testing is based on time consuming and expensive laboratory methods. The Interstate Shellfish Sanitation Conference (ISSC the primary industry/regulatory cooperative body in the US) has stated that the development of field deployable rapid inexpensive screening methods is a major unmet need. Portable rapid inexpensive technologies to detect HAB toxins could help improve the timeliness and effectiveness of toxin testing enabling more shellfish to be marketed while simultaneously meeting the priority of protecting public health. The United States has regulatory limits for common toxins found in shellfish meat. The US requires testing of shellfish meat for saxitoxin (STX) which causes paralytic shellfish poisoning (PSP) domoic acid (DA) which causes amnesic shellfish poisoning (ASP) and okadaic acid (OA) which causes diarrheic shellfish poisoning (DSP). Currently tests for these three toxins can be time consuming and expensive which hinders the distribution of harvested shellfish. MBio Diagnostics is developing a transformative platform technology that will enable users in the field to perform cost-effective multiplexed rapid laboratory-quality HAB toxin testing. This technology will protect the safety of the nation's food supply while enabling expansion of aquaculture by reducing the time and cost necessary to bring shellfish to market. There are five primary objectives in this proposal. First MBio will develop a triplex assay for measuring STX/DA/OA in shellfish near the regulatory limits. Second Mbio will tune this multiplexed assay for maximum sensitivity to enable detection of these toxins in seawater. Third congener coverage of all available reference materials will be tested. Fourth a portable method for shellfish homogenization cell lysis in seawater and extraction and hydrolysis methods will be developed. Fifth spikes into negative shellfish samples and samples naturally containing toxins will be tested. There is significant commercialization potential for this product. The ISSC summarized priorities for improving shellfish monitoring for HAB Toxins including a need for" screening methods for qualitative or semi-quantitative detection of toxins: field deployable by managers and industry reliable with respect to guidance levels (no false negatives and minimal false positives) and inexpensive rapid and facile". MBio's ArraySystem meets these needs. With more than 1400 shellfish harvesters in the US this is an attractive niche market. When taken in the context of the global potential and in conjunction with MBio's water-related toxin test product development the overall market potential is significant. The anticipated triplex STX/DA/OA assay is expected to meet or exceed all customer needs for rapid cost-effective and accurate testing for these toxins and achieve significant market share.