CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
Theradiag (Paris:ALTER), a French company specializing in diagnostic tests for autoimmune and infectious diseases, today announces the market launch of a CE-marked antigen test for detecting COVID-19.
On September 16, 20201, an order dated September 15, 2020, amending the order of July 10, 2020 stipulating the general measures required to tackle the COVID-19 epidemic in regions emerging from the health state of emergency and those where it has been prolonged, was published in the French Official Journal. Pursuant to this order, antigen tests are now officially approved for detecting
COVID-19 among asymptomatic patients in France, a measure designed to ease pressure on medical biology labs.
The antigen test: a new diagnostic tool for tackling COVID-19
Like RT-PCR tests, antigen tests are carried out using a swab to take a nasopharyngeal sample.
The swab is then analyzed directly at the test location, without the need for specific equipment or personnel. Delivering a result in less than 15 minutes after taking the sample, the test detects the presence of SARS-CoV-2 virus proteins or virus fragments, unlike RT-PCR tests which determine the presence of genetic material (DNA, genomes, etc.) belonging to the virus.
The test was developed by CerTest Biotec, a longstanding Spanish partner of Theradiag specializing in direct detection of respiratory pathogens using rapid tests.
Theradiag: the French specialist in lab-based diagnosis
Founded in 1986, Theradiag specializes in the development of diagnostics capable of measuring treatment efficacy, particularly in the field of biotherapy, for autoimmune diseases and cancer, a discipline known as theranostics (therapy + diagnostics), in which Theradiag is the world leader.
Going further than mere diagnostics, theranostics is designed to enable clinicians to define individual treatment for each patient by controlling treatment efficiency and anticipating potential side-effects inherent in biotherapies. Theradiag seeks to promote customized medicine by establishing individual treatment tailored to the specific needs of each patient.
The market launch of the antigen test forms part of the campaign Theradiag launched in April to contribute to tackling COVID-19, involving the development of serology tests to detect specific COVID-19 antibodies in patients. The new test expands Theradiag’s range of tools for diagnosing COVID-19.
Theradiag CEO Bernard de Castelnau said: “The current resurgence of COVID-19 infections has increased the need for rapid and effective diagnostic tests. By launching this antigen test in France, Theradiag intends to consolidate and step up its support for patients and health authorities in tackling this pandemic.”
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.
For more information about Theradiag, please visit our website: www.theradiag.com