Rapid, Multiplexed Detection of Algal Toxins in Shellfish and Seawater

MBio Diagnostics is proposing to develop a portable rapid inexpensive technology formore effective detection of harmful algal bloom (HAB) toxins in shellfish.The proposedproduct will help producers and managers get more product to market while ensuringthe safety of this commercially important food supply during HAB events.Shellfish arefilter feeders and can accumulate HAB toxins during blooms.These toxins can causeserious health effects including temporary paralysis intestinal or respiratory distress oreven death.Shellfish harvest closures due to HAB toxins are required to protect publichealth.Current testing is based on time consuming and expensive laboratory methods.The Interstate Shellfish Sanitation Conference (ISSC the primary industry/regulatorycooperative body in the US) has stated that the development of field deployable rapidinexpensive screening methods is a major unmet need.Portable rapid inexpensivetechnologies to detect HAB toxins could help improve the timeliness and effectivenessof toxin testing enabling more shellfish to be marketed while simultaneously meetingthe priority of protecting public health.The United States has regulatory limits for common toxins found in shellfish meat.TheUS requires testing of shellfish meat for saxitoxin (STX) which causes paralytic shellfishpoisoning (PSP) domoic acid (DA) which causes amnesic shellfish poisoning (ASP)and okadaic acid (OA) which causes diarrheic shellfish poisoning (DSP).Currentlytests for these three toxins can be time consuming and expensive which hinders thedistribution of harvested shellfish.MBio Diagnostics is developing a transformativeplatform technology that will enable users in the field to perform cost-effectivemultiplexed rapid laboratory-quality HAB toxin testing.This technology willprotect the safety of the nation's food supply while enabling expansion of aquaculture byreducing the time and cost necessary to bring shellfish to market.There are five primary objectives in this proposal.First MBio will develop a triplexassay for measuring STX/DA/OA in shellfish near the regulatory limits.Second MBiowill tune this multiplexed assay for maximum sensitivity to enable detection of thesetoxins in seawater.Third congener coverage of all available reference materials will betested.Fourth a portable method for shellfish homogenization cell lysis in seawaterand extraction and hydrolysis methods will be developed.Fifth spikes into negativeshellfish samples and samples naturally containing toxins will be tested.There is significant commercialization potential for this product.The ISSC summarizedpriorities for improving shellfish monitoring for HAB Toxins including a need for"screening methods for qualitative or semi-quantitative detection of toxins: fielddeployable by managers and industry reliable with respect to guidance levels (no falsenegatives 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 isan attractive niche market.When taken in the context of the global potential and inconjunction with MBio's water-related toxin test product development the overall marketpotential is significant.The anticipated triplex STX/DA/OA assay is expected to meet orexceed all customer needs for rapid cost-effective and accurate testing for these toxinsand achieve significant market share.