Beckman Coulter Inc. Archives - Medical Design Sourcing

HHS puts $6.5M more toward COVID-19 testing

The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month.

The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) will provide laboratory equipment supplied by Beckman Coulter and Thermo Fisher Scientific (NYSE:TMO) and increase staffing and infrastructure to boost testing nationwide by an additional 1 million tests each week by early October, according to the agency.

Aegis will add laboratory staff and begin construction on new lab space at its Nashville testing facilities to meet its goal of processing more than 60,000 test samples per day beginning in September. Aegis has agreed to partner with the Office of the Assistant Secretary for Health to perform testing of samples from select locations with vulnerable populations, accor…

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…

Beckman Coulter COVID-19 antibody test receives FDA EUA

Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay.

Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE Mark, according to a news release.

Beckman Coulter said it is capable f delivering more than 30 million tests a month, having already received independent validation for its test from the Henry Ford Health System, along with regulatory authorization.

“We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford’s COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation,” Henry Ford Health division head of chemistry-pathology Dr. Bernard Cook said in the release. “Henry…

Beckman Coulter wins CE Mark for COVID-19 antibody test

Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe.

Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the globe. It already has more than 16,000 immunoassay analyzers worldwide and ramped up its manufacturing to deliver more than 30 tests per month.

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