While aiming to double its manufacturing capacity to more than 50 million blood tests per month, Siemens Healthineers has begun shipping its COVID-19 serology kits internationally, for use on about 20,000 analyzer systems installed worldwide.
The company recently received a CE mark for its IgM and IgG antibody test, designed to run on its high-throughput Advia Centaur and Atellica systems—the latter capable of running up to 440 tests per hour. The kit is currently being reviewed by the FDA for emergency use in the U.S.
Siemens plans to increase production at its sites in Walpole, Massachusetts, and Newark, Delaware, and said it expects to hit the 50-million test target in June.
The company also aims to ship more than 2.5 million molecular, PCR-based coronavirus tests each month, which received an FDA authorization early this month and a CE mark in late April. According to analysts at Bernstein, the company has already sold 500,000 tests in Europe.
RELATED: Siemens Healthineers cuts ribbon on $300M IVD manufacturing plant project outside Boston
Siemens described its total antibody test’s performance as 100% sensitivity and 99.8% specificity—including in detecting the neutralizing antibodies that connect to and block the novel coronavirus’s spike protein, which allows it to enter and infect cells.
“Not all antibody tests are created equal,” Siemens’ president of laboratory diagnostics, Deepak Nath, said in a statement. “A high-quality test that targets the right protein and is highly scalable is essential for antibody testing to help ensure we effectively manage the threat of COVID-19.”
RELATED: The top 10 medtech companies of 2024 | Siemens Healthineers
“Siemens Healthineers sought to provide a highly accurate antibody test that could reach millions of people to address the current need for identifying immune response, and also for delivering long-term value as we look toward immunity and vaccination,” Nath added.
The company is also developing similar tests for its Dimension Vista and EXL systems, as well as a specific IgG test to meet different clinical needs.