CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (ISIN: FR0004197747, Ticker: ALTER) (Paris:ALTER), a company specializing in in vitro diagnostics and theranostics, announces the publication of a study that meets French National Authority for Health (HAS) requirements and highlights the quality of the antigenic tests it markets.
The study, conducted by the virology laboratory of the Centre Hospitalier Universitaire d’Amiens from October 18 to November 27, compared the Certest antigen test distributed by Theradiag to the reference RT-PCR test for the detection of Covid-19. For this purpose, the HAS defined a clear framework for the protocols to be put in place to determine test characteristics, in order to eliminate as much bias in the comparison results as possible. This means that the study was conducted on patients with mild to moderate symptoms and recruitment was carried out prospectively (there was no biological evidence that SARS-Cov-2 was present in the patient prior to testing). In addition, the samples were never frozen. The results of the study validated the sensitivity and specificity of the Certest antigen tests distributed by Theradiag for patients with high and very high viral loads. These results confirm the performance of the studies already conducted by the manufacturer.
This validation of the tests in accordance with HAS methodology is a prerequisite for continued publication on the lists of the French Directorate General for Health (DGS) and continued marketing of high-quality antigenic tests. It should be noted that if studies fail to comply with the methodology and sample types established by the HAS, this may result in biases in the results and unreliability in the tests.
“The results of this study, which uses the HAS methodology, demonstrate the high quality of our partner’s antigenic tests. This study affirms Theradiag’s distinctiveness in the antigenic testing market due to its transparency and compliance with all protocols established by the authorities for users and the fight against the pandemic”, said Bertrand de Castelnau, Theradiag’s Chief Executive Officer
A summary of this study (in French only) is available at
Theradiag is the market leader in biotherapy monitoring. Capitalizing on its expertise in the diagnostics market, the Company has been developing, manufacturing and marketing innovative in vitro diagnostic (IVD) tests for over 30 years.
Theradiag pioneered “theranostics” testing (combining therapy with diagnosis), which measures the efficacy of biotherapy in the treatment of chronic inflammatory diseases. Going beyond mere diagnosis, theranostics aims to help clinicians set up “customized treatment” for each patient. This method favors the individualization of treatment, evaluation of its efficacy and the prevention of drug resistance. In response to this challenge, Theradiag develops and markets the CE-marked TRACKER® range, a comprehensive solution of inestimable medical value.
The Company is based in Marne-la-Vallée, near Paris, has operations in over 70 countries and employs over 60 people. In 2019, the Company posted revenue of €9.6 million. The Theradiag share is listed on Euronext Growth Paris (ISIN: FR0004197747) and is eligible for the French PEA-PME personal equity plan.
For more information about Theradiag, please visit our website: www.theradiag.com