Health Canada has officially approved NanoSpeed Diagnostics’ Test4D Serum, a rapid point-of-care test designed to detect vitamin D levels from blood serum, marking a significant milestone for the Alberta-based biotech company.
It was made known on Tuesday following its announcement of obtaining approval.
The approval follows last year’s ISO 13485 Medical Device Single Audit Program (MDSAP) certification of NanoSpeed’s manufacturing facility in Alberta — a crucial step in meeting regulatory standards and securing domestic clearance.
Test4D Serum uses NanoSpeed’s proprietary technology to assess 25-hydroxycholecalciferol (25-OH vitamin D), offering both qualitative and quantitative results.
It was originally launched in 2013 as the world’s first point-of-care test for vitamin D deficiency and has since been used widely outside Canada, including in Europe, where it received CE Mark certification in 2014.
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“We are so pleased to achieve this significant milestone in Canada” said Dr. Seema Gupta, CEO of NanoSpeed. “As a company based in Alberta that has sold millions of our test globally, we are so happy to finally obtain approval to sell our test at home to patients and healthcare practitioners who increasingly recognize the importance that Vitamin D sufficiency plays in our everyday health.”
Vitamin D deficiency remains a widespread public health concern in Canada, with estimates indicating that around 60% of adults have suboptimal levels of 25-OH vitamin D.
This condition has been associated with numerous health issues, including poor bone health, cardiovascular disease, diabetes, certain types of cancer, linked to increased risk of depression, anxiety, and fatigue.
Traditionally, vitamin D levels are assessed through laboratory testing — a method that has grown in demand and cost over the last decade, putting added pressure on publicly funded healthcare systems.
POCT devices, such as Test4D Serum, offer the advantages of faster diagnosis, reduced laboratory errors, and lower healthcare expenditures, making them an attractive option for both practitioners and patients.
With Health Canada’s green light, NanoSpeed is now poised to distribute the test across the country, empowering healthcare providers to quickly identify vitamin D deficiency and initiate timely treatment interventions.
