poil-1 schreef op 18 mei 2020 20:46:
Theradiag: Approval of a First Covid-19 Test, 'RT-PCR'
May 18, 2020 01:47 PM Eastern Daylight Time
CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), specializes in in vitro diagnostics and theranostics.
Regarding the new Covid-19 testing activity recently initiated, Theradiag confirms that the viremia test developed by Mikrogen, AmpliCube Coronavirus SARS-Cov-2 (RT-PCR on nasopharyngeal swab), has just been approved by the National Reference Center of Paris (CNR). Exclusive distribution of the latter, in France, will soon begin via Theradiag's usual commercial networks.
This test joins about fifty PCR kits reimbursed by the French National Health Insurance and available on the French market. For the time being, no significant impact is being estimated on the company's 2020 sales in its forecasts.
The three other tests that have recently been filed with the CNR by Theradiag are serological tests in either ELISA (Enzyme Linked ImmunoSorbent Assay) or TDR (Rapid Diagnostic Test) format. These validation processes are still ongoing. The Company does not currently have new information in this respect. In addition, and on top of these other tests, the application for the test 100% developed by Theradiag will be filed in the coming weeks.
The Company will continue to keep the market and its stakeholders informed on the progress of these projects as soon as relevant.