Baxter, Biomérieux win CE mark for test predicting persistent severe acute kidney injury

Baxter (NYSE:BAX) and Biomérieux (EPA:BIM) today announced CE mark approval for the Nephroclear CCL14 test.

The companies designed the Nephroclear CCL14 test to predict persistent severe acute kidney injury (PS-AKI) and it can be used to support timely clinical decision-making and care pathways, according to a news release.

Baxter and Biomérieux plan to launch Nephroclear CCL 14 commercially across western Europe in 2022.

“Baxter is proud to partner with Biomérieux to offer the Nephroclear CCL14 test as an important new diagnostic option to support individualized AKI management that gives every patient the greatest opportunity for recovery,” GM of Baxter’s acute therapies business Reaz Rasul said in the release. “We remain committed to advancing purposeful innovation across the care continuum to help reduce complexity and enable efficiencies in critical care, especially as hospitals continue to feel the impact of the COVID-19 pandemic.”

The …

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DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production

The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test.

Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release.

BioFire’s COVID-19 test received FDA emergency use authorization (EUA) in March. The $3.1 million investment from the government will allow the company to increase its manufacturing capacity by expanding its facility in Salt Lake City with two new production lines.

The company is set to triple its manufacturing capacity for tests, beginning in September 2020. Those tests are compatible for use with BioFire’s FilmArray instruments that are, according to a news release, fielded across the DoD and Department of State.

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AdvaMed unveils COVID-19 diagnostic supply registry

AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses.

According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers (ETR: SHL), and Thermo Fisher Scientific (NYSE:TMO).

The AdvaMed registry is designed to compile information from the diagnostic companies, along with public data, to create a centralized and standardized COVID-19 diagnostic supply registry to update on weekly numbers at state and national levels regarding molecular, antigen and serology tests shipped in the U.S.

AdvaMed said in the release that the registry will also help streamline communicati…

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