NanoSpeed Diagnostics Receives Health Canada Approval for Test4D Test

• Test4D Serum is a qualitative test to detect Vitamin D levels in the blood.
• Test4D is ideal for healthcare professionals to use as a screening test or to monitor patients’ Vitamin D levels for overall health.

EDMONTON, Alberta--(BUSINESS WIRE)--NanoSpeed Diagnostics Inc. (“NanoSpeed”) is pleased to announce that Health Canada has approved Test4D Serum which is indicated to be used to detect Vitamin D in blood serum. Test4D Serum is one of the many products in the Company’s catalogue that uses NanoSpeed’s proprietary technology to detect Vitamin D deficiency in the blood, both quantitatively and qualitatively. Test4D was developed as the world’s first point-of-care test for Vitamin D deficiency and launched in 2013. ISO 13485 MDSAP certification in 2024 for the NanoSpeed manufacturing facility based in Edmonton, Alberta was critical for the approval from Health Canada.

“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.”

Dr. Seema Gupta continues, "As we celebrate this milestone, we want to thank our customers, distribution partners, employees, research and development collaborators, investors and government funders, both federally and provincially, for their continued support."

This regulatory approval for Test4D follows the 2014 CE Mark approval by the European Union (EU). NanoSpeed’s other commercial point of care products for Vitamin B12, Ferritin, and Vitamin A have already received approvals to use CE Mark and UKCA.

About NanoSpeed Diagnostics Inc.

NanoSpeed, incorporated in 2009, develops proprietary diagnostic/screening test kit platforms based on their Lateral Flow Immuno Assay and Lab-on-a-Chip technologies. These technological advancements provide patients with cost effective and reliable testing tools that will address the increasing needs of the healthcare industry, regulatory agencies and consumers. For more information please visit: www.nanospeed.ca

About Vitamin D deficiency and Test4D™

The global market potential for Vitamin D testing is estimated to be over $600 billion. Vitamin D deficiency is a common problem in Canada, where 60% of adults have suboptimal levels of 25-OH Vitamin D. Vitamin D deficiency has been associated with abnormalities in absorption of calcium, phosphorus, and bone metabolism; cardiovascular disease; diabetes; cancer; osteomalacia and osteoporosis in adults; and rickets in children. It has also been linked to an increased risk of depression, anxiety, and fatigue due to its role in regulating brain function and emotional well-being. Deficient Vitamin D levels are typically the result of an inadequate intake of Vitamin D through sunlight, diet, or supplements, or due to malabsorptive disorders.

25-OH Vitamin D levels are currently measured through laboratory testing. Over the past decade, there has been an incremental surge in the demand for Vitamin D testing, resulting in increasing costs to government supported healthcare systems. An alternative to laboratory testing is Point-of-Care-Testing (POCT), medical testing that occurs outside of a clinical laboratory and near the patient. Potential advantages of POCT include reduction in errors and costs to the healthcare system, and the provision of quick clinical diagnoses.

To address the demands of Vitamin D testing, NanoSpeed Diagnostics Inc. developed Test4D, a POCT device for the qualitative detection of 25-OH Vitamin D in human blood obtained via fingertip puncture.

Test4D is available for commercial sale through distributors or can be purchased directly from NanoSpeed.