BioMedomics receives Health Canada authorization for its CoV-SCAN Rapid Antigen Test

Morrisville, NC, USA – BioMedomics, a renowned player in the medical diagnostics field, has recently received authorization from Health Canada’s Medical Device Directorate to import and distribute its CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit. This significant achievement underscores the accuracy and reliability of BioMedomics’ test kit in detecting the presence of COVID-19.

The CoV-SCAN Rapid Antigen Test is a result of collaboration between BioMedomics and a major academic medical institution in the United States. The kit employs a panel of antibodies that allows it to detect various variant viruses, including Omicron and its many subtypes, from human specimens. BioMedomics’ test kit stands out from existing approved rapid antigen tests due to its incorporation of novel antibody technologies licensed from a world-leading group on COVID-19 at a major US academic institution. Specifically, the kit uses multidomain antibodies, which originally derived from human COVID-19 patients’ antibody selections, and is uniquely designed to detect all existing COVID variants and any future emerging variants.

In a clinical trial, the CoV-SCAN demonstrated a sensitivity of 95% in specimens with CT values less than or equal to 30 and a specificity of 100%. Furthermore, the test detected most specimens with CT values greater than 30, with an average value of 35.3. The CoV-SCAN is designed for professional use and can be used with anterior nasal swab specimens collected from individuals who are symptomatic within five days of symptoms, ages 2 years and older. The kit provides results in just 15 minutes. The COVID-19 Antigen External Control Kit, designed specifically for the CoV-SCAN, is available for purchase separately from BioMedomics.

“We are thrilled to have received Health Canada’s authorization for the CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit,” said Dr. Frank Wang, CEO of BioMedomics. “This approval is a testament to the hard work and dedication of our team working with our great partner in developing a reliable and accurate test kit that can be used by healthcare professionals in the fight against COVID-19.”

The CoV-SCAN Rapid Antigen Test is now available for use in Canada through authorized channels. To purchase the kit or obtain more information about it, visit the BioMedomics website and contact the company’s sales team.

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