CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, today provides an update on its new Covid-19 test program launched in response to the global pandemic.
To date, four tests have been approved by the National Reference Center in Paris (CNR):
Two tests distributed by Theradiag (CE marked by their manufacturers):
- One PCR test: Mikrogen - ampliCube Coronavirus SARS-CoV-2 previously mentioned
- Diagreat - 2019-nCoV IgG/IgM Antibody Rapid Test Kit
Two tests labeled under the Theradiag brand
- Theradiag rapid test - TDR Covid-19 IgG+IgM THERA
- Theradiag ELISA test - ELISA COVID-19 THERA02 IgG and IgM
The last two tests have just been CE marked and, as such, may now also be marketed in France and abroad via Theradiag’s usual sales networks, in accordance with applicable regulatory restrictions in each country.
The company highlights that tests already exist on the market and that reimbursement policies vary from country to country. In France, the amount of National Health Insurance reimbursement depends on the type of test conducted. The list of serology tests covers was recently published and the amount of reimbursement for these tests is limited. Nevertheless, Theradiag plans to leverage its recognized expertise in ELISA technology: the company will be able to leverage on this to market the last Theradiag labeled test.
As mentioned previously, these last two diagnostic kits are designed and assembled by Theradiag in its French laboratories near Marne-la-Vallée (Paris region). They are mainly used by medical analysis laboratories, most of which are already equipped with high-speed automated immunoserology analyzers.
Meanwhile, Theradiag continues to invest in R&D in this field in order to bring increasingly reliable and pertinent solutions to market within minimum lead times.
As marketing has just begun, it is still very difficult to measure the potential impact of these tests on 2020 revenue. The Company does not expect them to have a radical impact at present. Theradiag remains first and foremost a leading player in biotherapy monitoring.
In its core businesses of in vitro diagnostic tests (IVD) and theranostics, Theradiag is pursuing its strategy by implementing the business continuity plan rolled out in mid-March and harnessing the commitment of its people. The Company has managed to maintain a satisfactory level of business amid the global pandemic. Resumption of normal business still depends mainly on the degree of access to Theradiag’s hospital customers, in France and abroad.
The Annual General Meeting of shareholders, convened for the second time on June 25, 2020, is a
key moment for your Company. Your participation is really matters. It gives you
the opportunity to contribute to Theradiag’s business plans through your vote.
Don’t forget to vote via the VOTACESS platform or grant proxy as soon as possible.
- Annual General Meeting convened for a second time, on June 25, 2020
- H1 2020 revenue, Tuesday, July 21, 2020
- H1 2020 results, Monday, September 21, 2020
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