NEW YORK – NanoSpeed Diagnostics announced Tuesday that it has obtained regulatory approval in Canada for a qualitative test to assess vitamin D in a fingertip blood sample at the point of care.
The Test4D Serum assay is a lateral flow immunoassay that detects vitamin D in blood serum and can be used by healthcare professionals for screening or monitoring. The test produces results in 10 minutes, according to NanoSpeed's website.
The test was CE marked in 2014 and is part of the Edmonton, Canada, firm's portfolio of point-of-care products that also includes CE-marked and UK conformity assessed tests for vitamin B12, ferritin, and vitamin A.
In a statement, NanoSpeed CEO Seema Gupta called the approval a "significant milestone" and noted that the company has sold millions of the test globally and will now be able to sell the test in its home country.
More than half of Canadian adults have suboptimal vitamin D levels, according to the statement, and deficiency — caused by inadequate intake or malabsorption — can lead to a host of physical and mental health issues. The global market for vitamin D testing is estimated to be $600 billion, NanoSpeed said, and levels are typically measured through lab testing.
Test4D is now available through distributors as well as directly from NanoSpeed.