“It is very much like a cholesterol test, except easier to change through dietary modifications or supplementation.” “If individuals follow advice to increase their omega-3 intake based on their own Omega-3 Index, then improved health should follow,” Polreis said. With FDA approval, the company hopes to create partnerships and grow awareness of the benefits to increasing an individual’s Omega-3 Index. Using mostly online sales this year, OmegaQuant still saw its number of samples analyzed increased by 38 percent, similar to its increase in 2016, and “we expect this to continue or increase in 2018,” Polreis said. This potentially opens up the door to work with major brands with no need to worry about the regulatory status of the test.” “One of the first questions we usually get when we deal with clients in the retail space is about the regulatory status of the test, and now we have an answer. While it remains to be seen how significant an impact the approval will be, “we feel this is a major development for OmegaQuant,” general manager Jason Polreis said. The FDA’s approval came from the Office of In Vitro Diagnostics and Radiological Health of the Food and Drug Administration following a review of OmegaQuant’s internal data that included method validation, consumer testing, clinical utility, safety considerations, marketing materials and reports for the Omega-3 Index. “The fact that the FDA now has given this test its stamp of approval gives OmegaQuant a fantastic springboard to bring this science to a very broad audience.” “South Dakota and OmegaQuant really are at the forefront of this field,” said Joni Johnson, executive director of South Dakota Biotech. William Harris, an internationally recognized expert in omega-3 fatty acids and co-inventor of the Omega-3 Index test.

specializing in fatty acid analysis that is CLIA-certified. This agreement with FDA will make it possible for more consumers to learn their personal omega-3 status, and if they act on that information and increase their EPA and DHA omega-3 intake, then improved health outcomes should follow,” said Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s. “Omega-3 blood tests have been around for some time, and the emerging evidence is demonstrating how important it is to understand one’s omega-3 status. An Omega-3 Index in the range of 8 percent to 12 percent is one indicator of better overall health. The Omega-3 Index is the level of long-chain omega-3 fatty acids, EPA+DHA, in red blood cell membranes expressed as a percentage of total fatty acids. The Omega-3 Index developed by OmegaQuant is a blood test of omega-3 fatty acid nutritional status that can be measured from a dried blood spot. OmegaQuant LLC has developed a blood test to measure omega-3 levels, which are important for heart, brain and joint health and are below recommended levels in many people. This piece is presented by South Dakota Biotech.Ī Sioux Falls company has received approval from the FDA to market its signature Omega-3 Index test as an over-the-counter, general health and wellness product.

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