Cepheid wins CE Mark for COVID-19, flu, RSV combo diagnostic

Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic.

Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.

The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). According to a news release, test results are made available after about 36 minutes.

Cepheid noted that the addition of a third gene target to the Plus version of the Xpert Xpress diagnostic platform offers more coverage to mitigate the potential effects of future viral genetic drift as variants of COVID-19 continue to develop.

The company expects to begin shipping the newly approved test to countries accepting CE-marked products this month.

“During this time of year, healthcare provid…

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Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic

Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.

Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV).

Get the full story at our sister site, MassDevice.

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Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic

[Image from Cepheid]Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.

Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV).

Nearly one year ago, the company received EUA for the Xpert Xpress testing platform. According to a news release, the “plus” version of the test offers a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations.

The company touts the test as capable of delivering results in approximately 36 minutes. It expects to begin shipping to U.S. customers in the next few weeks.

“This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with COVID-19, including Flu A, Flu B, and respirator…

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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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