Health Canada has granted approval for NanoSpeed Diagnostics’ Test4D Serum, designed to identify vitamin D levels in blood serum.
This development follows the ISO 13485 MDSAP certification of the company’s manufacturing facility in Alberta, Canada, last year, which was said to be crucial in obtaining this regulatory clearance.
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The test claims to leverage NanoSpeed’s technology to assess the deficiency of vitamin D both qualitatively and quantitatively.
It is part of the company’s catalogue and was initially introduced in 2013 as the first point-of-care test for this purpose.
Health Canada’s approval adds to the test’s existing CE Mark certification granted by the European Union in 2014.
According to the company, the Vitamin D deficiency is a widespread concern in the country, with 60% of the adult population exhibiting less than optimal levels of 25-hydroxycholecalciferol (25-OH) vitamin D.
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By GlobalDataThis deficiency is linked to various health issues, including impaired bone metabolism, cardiovascular conditions, diabetes, and certain cancers.
Traditionally, 25-OH vitamin D levels are measured via lab testing, which has seen a significant increase in demand and associated expenses for government-backed healthcare systems over the past ten years.
NanoSpeed CEO Dr Seema Gupta said: “As a company based in Alberta that has sold millions of our tests globally, we are so happy to finally obtain approval to sell our test at home to patients and healthcare practitioners who increasingly recognise the importance that vitamin D sufficiency plays in our everyday health.”
NanoSpeed noted that point-of-care testing (POCT), which allows medical testing near the individual and outside of clinical laboratories, offers an alternative.
POCT can potentially reduce errors and healthcare expenses while providing rapid clinical diagnoses.
In response to the growing need for vitamin D testing, the company created this POCT device for the identification of 25-OH vitamin D via fingertip puncture in human blood.
