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FIND and Unitaid launch call for EOI to fill major diagnostic gaps in COVID-19 detection

The Foundation for Innovative New Diagnostics and Unitaid announced today that the organizations have launched a call for expressions of interest to accelerate the availability and manufacturing scale-up of rapid diagnostic tests for the detection of SARS-CoV-2 antigens. Reliable, affordable Ag RDTs have been identified as key tools in the global response to COVID-19, as they could enable robust detection of active SARS-CoV-2 infection for both patient management and contact tracing purposes in decentralized settings.

10 Jul 2020

LGC acquires The Native Antigen Company, strengthening its offer to the IVD sector

Today, LGC announced the acquisition of The Native Antigen Company (NAC), one of the world’s leading suppliers of high quality infectious disease antigens and antibodies.

9 Jul 2020

Thermo Scientific MAS Omni Infectious Controls launched to assess the performance of serological assays

Thermo Fisher Scientific, the world leader in serving science, today announced the availability of the Thermo Scientific MAS Omni Infectious Disease quality control sets for monitoring serological assays for analytes such as HIV 1&2, Hepatitis B & C virus, Syphilis and HTLV I/II.

From Thermo Fisher Scientific Inc. 3 Jul 2020

Novel biomarkers required to triage and monitor severely ill COVID-19 patients

Diagnostics company SphingoTec GmbH ("sphingotec") announced today the results of a working group meeting of clinical experts that discussed the utility of sphingotec's diagnostic solutions for acute and critical care in supporting the triage, diagnosis, and management of severely ill COVID-19 patients.

18 Jun 2020

QuantuMDx receives CE-IVD marking for SARS-CoV-2 detection assay

QuantuMDx Group Limited, a UK-based life sciences company developing transformational point-of-care molecular diagnostics, today announces its SARS-CoV-2 detection assay has been CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within the European Union.

10 Jun 2020

Promega announces CE marking for OncoMate MSI Dx Analysis System in Europe

Promega Corporation today announced CE marking for the OncoMate MSI Dx Analysis System as a new in vitro diagnostic medical device in Europe.

From Promega Corporation 10 Jun 2020

Antibody tests were hailed as way to end lockdowns. Instead, they cause confusion.

Aspen was an early COVID-19 hot spot in Colorado, with a cluster of cases in March linked to tourists visiting for its world-famous skiing. Tests were in short supply, making it difficult to know how the virus was spreading.

28 May 2020

SignalChem Biotech Inc. launches COVID-19 elisa kits for diagnostic research

SignalChem, a global leader in cell signaling and protein engineering, has been conducting research on new coronaviruses since the outbreak of the virus.

From SignalChem Biotech Inc. 28 May 2020

High DPP3 concentration in the blood predicts multiple organ failure in burn patients

Diagnostics company SphingoTec GmbH ("sphingotec") and 4TEEN4 Pharmaceuticals GmbH ("4TEEN4") announced today the publication of new data showing that high blood levels of Dipeptidyl Peptidase 3 (DPP3) are indicating upcoming multiple organ failure and mortality risk in burn patients.

15 May 2020

FDA provides emergency use authorization to PerkinElmer for COVID-19 testing

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test.

From Revvity 26 Mar 2020

India gives Roche Diagnostics the license to conduct coronavirus tests, looks to delay disease progression

Following the news that the Drug Controller General of India has given license to Roche Diagnostics India to conduct coronavirus tests, Rohit Anand, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers his view.

From Roche Sequencing and Life Science 20 Mar 2020

Sphingotec’s bio-ADM can reliably support physicians in identifying high-risk sepsis patients

Diagnostics company SphingoTec GmbH today reported on new data on the utility of endothelial function biomarker bioactive Adrenomedullin

5 Mar 2020

Promega's custom manufacturing capabilities support rapid development of Logix Smart COVID-19 Test

Promega Corporation is being recognized by Utah-based Co-Diagnostics, Inc.

From Promega Corporation 26 Feb 2020

Beckman Coulter Life Sciences launches Europe’s first CE-IVD, 13-color clinical flow cytometer

Beckman Coulter Life Sciences has introduced the DxFLEX, Europe’s first CE-IVD, 13-colour clinical flow cytometry system.

From Beckman Coulter Life Sciences - Flow Cytometry 4 Feb 2020

Determining Microsatellite Instability Status Using Multiplex PCR-Based Methods

Determining microsatellite instability status using multiplex PCR-based methods used to screen for Lynch Syndrome, a dominant hereditary cancer propensity.

From Promega Corporation 24 Jan 2020

Sphingotec's new biomarker bio-ADM identifies ICU patients who need immediate organ support

Diagnostics company SphingoTec GmbH today announced a publication in Critical Care1 with data on 2,000 ICU patients demonstrating that sphingotec's proprietary biomarker bio-ADM (Bioactive Adrenomedullin) not only identifies high-risk patients for septic shock at admission but also identifies patients in the general ICU patient population who require immediate life-saving therapeutic intervention.

23 Dec 2019

IVD News and Research

FIND and Unitaid launch call for EOI to fill major diagnostic gaps in COVID-19 detection

LGC acquires The Native Antigen Company, strengthening its offer to the IVD sector

Thermo Scientific MAS Omni Infectious Controls launched to assess the performance of serological assays

Novel biomarkers required to triage and monitor severely ill COVID-19 patients

QuantuMDx receives CE-IVD marking for SARS-CoV-2 detection assay

Promega announces CE marking for OncoMate MSI Dx Analysis System in Europe

Antibody tests were hailed as way to end lockdowns. Instead, they cause confusion.

SignalChem Biotech Inc. launches COVID-19 elisa kits for diagnostic research

High DPP3 concentration in the blood predicts multiple organ failure in burn patients

FDA provides emergency use authorization to PerkinElmer for COVID-19 testing

India gives Roche Diagnostics the license to conduct coronavirus tests, looks to delay disease progression

Sphingotec’s bio-ADM can reliably support physicians in identifying high-risk sepsis patients

Promega's custom manufacturing capabilities support rapid development of Logix Smart COVID-19 Test

Beckman Coulter Life Sciences launches Europe’s first CE-IVD, 13-color clinical flow cytometer

Determining Microsatellite Instability Status Using Multiplex PCR-Based Methods

Sphingotec's new biomarker bio-ADM identifies ICU patients who need immediate organ support

Sphingotec's penKid is a reliable marker for detection and monitoring of acute kidney injury

Promega and Merck collaborate to develop MSI companion diagnostic for use with anti-PD-1 therapy

New blood self-collection device quickly estimates a person's exposure to radiation

Quanterix Serum Nf-L assay powers key trial and study results presented at ECTRIMS 2019

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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