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Tag: diagnostic test


Biomarker, Innovation

Cepheid obtains CE mark for Covid-19/Flu/RSV diagnostic test

October 15, 2021

Via: medicaldevice-network.com

Cepheid has obtained CE mark for its molecular diagnostic test to qualitatively identify SARS-CoV-2, influenza virus and respiratory syncytial virus (RSV) from one patient sample. The Xpert Xpress CoV-2/Flu/RSV plus offers a third gene target for detecting SARS-CoV-2 to boost […]


News

FDA grants EUA to Cepheid’s rapid Covid-19/Flu/RSV diagnostic test

September 15, 2021

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Cepheid’s rapid molecular diagnostic test, Xpert Xpress CoV-2/Flu/RSV plus. The test is indicated for qualitative identification of the viruses that cause Covid-19, Flu A, Flu B […]


Regulatory

US under pressure to increase its Covid-19 diagnostic testing

March 6, 2020

Via: medicaldevice-network.com

The Centers for Disease Control and Prevention (CDC) mass-produced a diagnostic test kit for the novel Covid-19 coronavirus in early February. After these testing kits were shipped, however, it was discovered that they were unreliable, with news reports indicating they […]


Biomarker, Innovation

Researchers develop microfluidic test to detect Lyme disease

October 14, 2019

Via: medicaldevice-network.com

Scientists at Columbia Engineering have developed a diagnostic test that leverages a microfluidic approach to detect Lyme disease within 15 minutes. Existing tests involve running of two assays, ELISA and western blot, to identify antibodies against the Borrelia burgdorferi bacterium, […]


Innovation, Research

Scientists develop diagnostic test for chronic fatigue

April 30, 2019

Via: medicaldevice-network.com

CFS sufferers can often have their symptoms written off as malingering, because the diagnostic test results for organ function and blood and immune cell counts all are normal in these patients. The new test is based on how a person’s […]


Innovation, Research

US researchers unveil ‘holy grail’ blood test for cancer

June 1, 2018

Via: medicaldevice-network.com

Researchers from Cleveland Clinic in Ohio, US have unveiled a new diagnostic test that can identify ten different cancer types in a blood sample, even before the appearance of disease symptoms. The non-invasive test works by detecting fragments of DNA […]


Regulatory

Foundation Medicine gets approval for cancer test in US

December 1, 2017

Via: medicaldevice-network.com

Molecular information firm Foundation Medicine has secured approval from the US Food and Drug Administration (FDA) for its comprehensive companion diagnostic test, FoundationOne CDx, for solid tumours. The genomic profiling (CGP) test is designed to identify people who could benefit […]


Innovation, Research

Researchers show potential of using low-cost rapid diagnostic test to detect severe malaria

August 25, 2017

Via: The Medical News

Malaria is a leading cause of death for children living in Sub-Saharan Africa. Many children in rural areas seek care at local community health clinics, but these clinics lack reliable tests to distinguish severe and uncomplicated malaria. Working at a […]