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Siemens Healthineers Nabs CE Mark for Coronavirus Molecular Kit

NEW YORK ─ Siemens Healthineers said Wednesday it has received the CE mark for its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay, allowing for its use as a clinical diagnostic test in Europe.

The firm also registered the test with the Luxembourg Ministry of Health and said it plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.

The test, released as a research-use-only assay early this month, has shown 100 percent diagnostic sensitivity and 100 percent diagnostic specificity in method comparison studies when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs, the company said.

Sample-to-answer time, from extraction to result, takes two to three hours, depending on the molecular system and lab resources employed, according to Siemens Healthineers.

The FTD SAR-CoV-2 Assay can analyze up to 32 patient samples per kit and be run in laboratories simultaneously with FTD Respiratory Pathogens 21 and FTD FLU/HRSV molecular syndromic testing panels, which identify a wide range of pathogens that can cause acute respiratory infections.

On Friday, the company had announced it is developing a SARS-CoV-2 serology assay to detect IgM and IgG antibodies in blood. An antibody test can help indicate whether a person has developed immunity against SARS-CoV-2 and can reveal whether individuals, including those who were asymptomatic or had never been diagnosed with the disease, had COVID-19, Siemens Healthineers noted.