FDA signs off on biotech company’s Omega-3 test

Jan 05, 2018

FDA signs off on biotech company’s Omega-3 test

A 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.

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.

 

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. 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. An Omega-3 Index in the range of 8 percent to 12 percent is one indicator of better overall 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,” said Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s.

OmegaQuant is the only lab in the U.S. specializing in fatty acid analysis that is CLIA-certified. The company was founded in 2009 by Dr. William Harris, an internationally recognized expert in omega-3 fatty acids and co-inventor of the Omega-3 Index test.

“South Dakota and OmegaQuant really are at the forefront of this field,” said Joni Johnson, executive director of South Dakota Biotech. “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.”

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.

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.

“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. This potentially opens up the door to work with major brands with no need to worry about the regulatory status of the test.”

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.

With FDA approval, the company hopes to create partnerships and grow awareness of the benefits to increasing an individual’s Omega-3 Index.

“If individuals follow advice to increase their omega-3 intake based on their own Omega-3 Index, then improved health should follow,” Polreis said. “It is very much like a cholesterol test, except easier to change through dietary modifications or supplementation.”

The Omega-3 Index test can be ordered at omegaquant.com for $54.95. After placing an order, a test kit will be shipped that contains 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 five business days of receipt at the lab.



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