Siemens snags FDA approval for HIV combo test

Franz Walt

Siemens scored FDA approval for its HIV combo test, a win for the company as it looks to its diagnostics unit to chart some growth amid lagging fortunes.

Regulators gave a greenlight to Siemens ' ADVIA Centaur HIV Ag/Ab Combo (cHIV) assay, adding to its offerings for hepatitis A, B, C; eHIV; syphilis and other infectious diseases, the company said in a statement. Siemens' ADVIA combination test can simultaneously screen blood samples for HIV viral protein and antibodies produced in response to HIV viral infection, potentially allowing clinicians to detect the virus earlier and reduce transmission among patients.

"Siemens continues to invest in the development of new solutions that allow clinical laboratories to improve both patient care and workflow efficiency," Franz Walt, CEO of Chemistry, Immunoassay, Automation and Diagnostics IT Business Unit at Siemens Healthcare Diagnostics, said in a statement. "We are proud to offer our U.S. customers a broad range of high performance, fully automated infectious disease tests, which now includes the ADVIA Centaur HIV Ag/Ab combo assay."

The test, which has already been on the market in Europe since 2010, can check for both acute and established HIV-1/HIV-2. A third generation of the product will remain available on Siemens' Centaur systems, the company said in a statement.

The FDA approval marks a bright point for Siemens, as it continues to embark on a series of cost-cutting measures after separating out its healthcare business last October. In May, the company announced it would cut another 4,500 jobs in addition to the 7,800 it announced earlier, pushing the total number of layoffs past 10,000.

But Siemens is counting on promising results for its diagnostics unit to swing its numbers northward. CEO Joe Kaeser said in May that the company's diagnostics business has been growing by double digits in China. Those results, coupled with a "volume recovery" in Europe, could help Siemens gain some ground as it faces slower growth for its healthcare business. The company's revenues were up revenues jumped 13% year over year to €3.2 billion ($3.61 billion) during the second quarter, but profits fell by 2% to €526 million ($593 million).

- read the release

Special Report: The top companies in med tech: 2014 revenue results - Siemens

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