Food and Drug Administration Permits OmegaQuant to Market the Omega-3 Index Testtm

SIOUX FALLS, S.D., Dec. 13, 2017 /PRNewswire-iReach/ -- A Sioux Falls company, OmegaQuant, LLC has reached an agreement with the Office of In Vitro Diagnostics and Radiological Health of the Food and Drug Administration (FDA) that allows OmegaQuant to market its Omega-3 Indextm test as an over the counter, general health and wellness product. This action followed upon OmegaQuant's submission to the FDA of internal data that included method validation, consumer testing, clinical utility, safety considerations, marketing materials, and reports for the Omega-3 Indextm.

The Omega-3 Indextm is a blood test of omega-3 fatty acid nutritional status that can be measured from a dried blood spot.  The Omega-3 Indextm is the level of long-chain omega-3 fatty acids, EPA+DHA, in red blood cell membranes expressed as a percent of total fatty acids. An Omega-3 Indextm in the range of 8-12% is one indicator of better overall health. As a part of an overall healthy lifestyle, an Omega-3 Indextm in the 8-12% range may help to maintain heart, brain, eye and joint health. 

"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. 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." Adam Ismail, Executive Director, Global Organization for EPA and DHA Omega-3s.

Most Americans are below the desirable range, and could improve their Omega-3 Indextm by eating more EPA+DHA-rich foods or taking omega-3 supplements (fish, krill, algal, or cod liver oils). Some of the best seafood sources of omega-3 fatty acids are salmon, mackerel, herring, sardines and albacore tuna. DHA-fortified foods (such as eggs, milk) can also contribute to higher omega-3 intakes.

Recommendations for dietary EPA and DHA

Both the 2015-2020 Dietary Guidelines for Americans (DGA) and the American Academy of Nutrition and Dietetics recommend the consumption of at least 2 servings (i.e., about 8 ounces) per week of a variety of seafood, preferably omega-3 rich fish. This will provide between 250 and 500 mg per day of EPA and DHA on average.  The Dietary Guidelines state that this intake has been "associated with reduced cardiac deaths among individuals with and without pre-existing cardiovascular disease."

For perspective, the FDA has determined that the consumption of up to 3000 mg/day of EPA and DHA is generally recognized as safe.

The amount of EPA+DHA one would need to eat in order to raise their Omega-3 Indextm into the desirable range cannot be predicted with certainty. Many factors ?age, sex, weight, diet, genetics, smoking habits, medications you may be taking, and other medical conditions ? can all influence the body's response to EPA+DHA. Once a person increases their intake of EPA+DHA, the Omega-3 Indextm will begin to go up immediately, but will continue to change for 3-4 months. Therefore, re-testing should be done only 2-3 times per year.

How to order the Omega-3 Index

The Omega-3 Indextm test can be ordered at www.omegaquant.com for $54.95. After placing an order, a test kit will be shipped direct which will contain the supplies to safely collect a dried blood spot sample at home and a pre-paid return envelope. A personalized report including test results and recommendations are returned within 5 business days of receipt at the lab.

OmegaQuant, LLC

OmegaQuant is the only lab in the US specializing in fatty acid analysis that is CLIA-certified. OmegaQuant was founded in 2009 by Dr. William Harris, an internationally recognized expert in omega-3 fatty acids and co-inventor of the Omega-3 Indextm test. Dr. Harris was the recipient of five National Institutes of Health grants for studies on the effects of omega-3 fatty acids on human health. He has over 200 scientific publications and has been the author of two American Heart Association Scientific Statements on fatty acids and health. OmegaQuant continues to be involved in research with institutions such as Harvard, Stanford, Tufts, The Pennsylvania State University, The Ohio State University, the US Army, the National Institutes of Health, and many more. The goal of OmegaQuant is to offer the highest quality fatty acid analytical services to researchers and to provide simple tests of nutritional status to healthcare providers and individuals.

Contact:

Bill Harris

[email protected]

605-271-6917 x 2

Media Contact: Bill Harris, OmegaQuant, 605-271-6917, [email protected]

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SOURCE OmegaQuant