Cepheid
United States
344 articles about Cepheid
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Cepheid Receives FDA Clearance for Xpert® Xpress GBS
3/11/2024
Cepheid announced that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus.
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Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP
1/18/2024
Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert ® Xpress MVP.
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Social media campaigns may have been one factor that prompted Johnson & Johnson and Danaher to make a TB treatment and a test more accessible in low- and middle-income countries.
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Cepheid Announces Vitor Rocha as President
5/23/2023
Cepheid, a leading molecular diagnostics company, announced today that Vitor Rocha has officially joined the company in the role of President.
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Cepheid Introduces Xpert GBS LB XC
11/16/2022
Cepheid today announced the availability of Xpert ® GBS LB XC (extended coverage), a molecular diagnostic test for qualitative detection of Group B Streptococcus (GBS) using enriched Lim broth cultures of patient samples.
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Cepheid and BioGX Announce Collaboration to Develop Monkeypox PCR Test for the GeneXpert® System
6/27/2022
Cepheid and BioGX today announced a collaboration between the two companies to deliver a PCR test for Monkeypox that will run on the GeneXpert system.
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FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here's a look.
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Cepheid Receives Emergency Use Authorization for Xpert Xpress CoV-2/Flu/RSV plus
9/14/2021
Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress CoV-2/Flu/RSV plus
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Cepheid Receives CE-IVD Clearance for Two Next-Generation Xpert® HIV-1 Tests
7/29/2021
Cepheid announced that it has received CE-IVD clearance for Xpert® HIV-1 Viral Load XC and Xpert® HIV-1 Qual XC, next-generation extended-coverage tests for HIV testing.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 2, 2020.
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Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test
9/29/2020
Challenged by Similar Clinical Presentations, Accurate Detection & Differentiation of all 4 Viruses is Critical for Clinicians This Flu Season
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Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV
6/9/2020
Cepheid today announced the development of a next-generation test to assist global efforts in the fight against the spread of COVID-19 during the upcoming respiratory vir
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Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
3/21/2020
Cepheid announced it has received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
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Cepheid Receives FDA Clearance for Xpert® BCR-ABL Ultra Test
10/2/2019
Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia
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Cepheid Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG Test
5/29/2019
On-Demand Same-Day Extragenital Testing for Chlamydia and Gonorrhea Fills Critical Unmet Need in Fight Against Rising Rates of Chlamydial and Gonorrheal Infection
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CORRECTING and REPLACING SpeeDx and Cepheid Announce Test Partnership
4/28/2019
SpeeDx tests will be available through Cepheid’s FleXible Cartridge programme for the GeneXpert System
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SpeeDx and Cepheid Announce Test Partnership
4/16/2019
SpeeDx tests will be available through Cepheid’s FleXible Cartridge programme for the GeneXpert System
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Cepheid Announces FleXible Cartridge Program
4/15/2019
SpeeDx is the First Trusted Reagent Manufacturer to launch a new test for use on the GeneXpert® System
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Cepheid Receives CE-IVD Clearance for Xpert® HBV Viral Load
12/20/2018
Simplify Hepatitis B Treatment Management
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Cepheid Receives CE-IVD clearance for Xpert HCV VL Fingerstick
9/19/2018
Enables Hepatitis C Point-of-Care molecular testing and linkage to care