NEW YORK — Teracero Pharma said on Wednesday that partner Nal von Minden has received interim order from Canadian regulators authorizing its Nadal COVID-19 IgG/IgM Test.
The lateral flow chromatographic immunoassay, which was CE marked about a year ago, is designed to detect immunoglobin G and M against SARS-CoV-2 in whole blood, serum, or plasma, providing results within 10 minutes. It was developed by Moers, Germany-based Nal von Minden, which licensed its exclusive commercial rights in Canada and the US to Teracero.
According to Teracero, the test has shown up to 99.5 percent sensitivity and over 98 percent specificity in symptomatic individuals. The Montreal-based firm said it is working with Nal von Minden on additional clinical studies.
Health Canada's Interim Order allows products that may not fully meet Canadian regulatory requirements to be imported if they are manufactured to comparable standards, according to the Canadian government's website. The order is meant to help prevent shortages of items needed to address the COVID-19 pandemic.