A new stage in COVID-19 testing – Teracero Pharma reports receiving the first authorization for a COVID-19 serology rapid test under the Minister of Health’s Interim Order
nal von Minden GmbH’s NADAL COVID-19 IgG/IgM Test is highly sensitive and specific to antibodies against SARS-CoV-2, requires no special training, and can provide results within 10 minutesMONTREAL, March 17, 2021 (GLOBE NEWSWIRE) — Teracero Pharma Inc. (“teräcero”) and its German partner nal von Minden GmbH (“nal von Minden”) are pleased to announce that Health Canada, pursuant to the Interim order Respecting the Importation and Sale of Medical Devices in support against the COVID-19 pandemic, has issued an authorization for importation and commercialization of nal von Minden’s NADAL COVID-19 IgG/IgM Test (“NADAL Rapid Test”), a leading test exclusively distributed by teräcero in Canada.
The NADAL Rapid Test is highly specific and sensitive, as demonstrated repeatedly by numerous internal or independent clinical validation studies, including some by leading Canadian public health laboratories. Recently published results in the Journal of Clinical Microbiology (1), where the NADAL Rapid Test was compared to 10 laboratory-based tests and 2 other rapid tests, demonstrated that the NADAL Rapid Test performed equally well or better than the most recognized COVID-19 laboratory-based serology tests and outperformed the other two rapid tests.Benoît Hébert, President and CEO of teräcero, commented, “The availability of this new rapid serology test from nal von Minden, a recognized innovator in medical diagnostics and point-of-care testing, will help support the public health and medical communities in the fight against COVID-19. Approval of the NADAL serological test provides Canadians with a rapid and extremely sensitive test to monitor the progression of the natural immunity or vaccine-induced immunity in the general population.”Validation studies demonstrated that 15 days after the appearance of symptoms, the NADAL Rapid Test has a sensitivity of 95% which increases to more than 98% after 21 days and reaches 99.5% at 25 days or more. The NADAL Rapid Test has an extremely high specificity, exceeding 98%, in nine (9) independent studies in which more than 1250 clinical samples were analysed.Teräcero and nal von Minden are pursuing further clinical evaluations to support the medical community in an effort against COVID-19. Studies to demonstrate samples equivalences, and to evaluate the impact of the emergence of variants on the immune response measured by rapid tests are underway. Both companies are also collaborating to support Canadian COVID-19-related clinical research that requires a rapid, sensitive, and specific test to enroll and/or monitor subjects throughout a study.The NADAL Rapid Test is already commercialized in more than 20 countries, including Germany, France, and the United Kingdom. Teräcero also holds the rights for the USA and is exploring various collaboration opportunities with prospective partners.About nal von Minden.nal von minden GmbH, based in Moers, Germany, has been a specialist in the field of medical diagnostics for 38 years. Its portfolio includes rapid tests and laboratory tests for reliable diagnoses in the fields of bacteriology, cardiology, gynaecology, infectious diseases, urology, and toxicology. A COVID-19 antigen rapid test is the latest development. nal von minden GmbH has a total of about 220 employees at 9 European locations.About Teracero Pharma Inc.Teracero Pharma, an affiliate of Teracero Canada, is a new pharmaceutical company specialized in the commercialization and development of innovative, high-quality healthcare products, including medical devices and pharmaceuticals.1. Therrien C, et al. 2021. Multicenter evaluation of the clinical performance and the neutralizing antibody activity prediction properties of 10 high-throughput serological assays used in clinical laboratories.
J Clin Microbiol 59:e02511-20. https://doi.org/10.1128/JCM.02511-20.
For further information, please contact: Benoît Hébert, Ph.D., MBA
Email: Phone: 1-877-767-8261