In Vitro Diagnostics News and Research

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QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems

NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S..

From QIAGEN Manchester Limited 9 Jan 2024

Novel, rapid and efficient assay for SARS-CoV-2 neutralizing antibodies

Researchers validate a quick, highly efficient, and automated assay to detect neutralizing antibodies against SARS-CoV-2.

7 Feb 2022

New type of blood test can be used to detect cancers as well as metastatic disease

A publication by University of Oxford researchers describes a new minimally invasive and inexpensive blood test that can identify cancer in patients with non-specific symptoms.

12 Jan 2022

How the new In-Vitro Diagnostics Regulations are affecting the life sciences landscape

In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the upcoming changes to the regulations surrounding in-vitro diagnostics and how they might affect the life sciences landscape.

From Tecan 23 Nov 2021

MIP Diagnostics to support the development of challenging affinity reagents with new Molecular Imprinting Epitope Discovery

MIP Diagnostics has today announced the launch of its novel Molecular Imprinting Epitope Discovery Service.

26 Oct 2021

Diagnosis of viral infections using micro and nanoscale technologies

In a recent study, the authors provide a review on both micro- and nanoscale technologies that advanced the diagnosis of viral diseases.

3 Aug 2021

Bruker’s molecular phenomics research tools enable new insights into ‘long COVID’ and post-acute metabolic abnormalities

A clinical research collaboration on COVID-19 pheno-conversion and subsequent pheno-reversion has discovered transient and persistent systemic changes of the molecular signatures in patient blood samples three months after the acute COVID-19 disease phase.

From Bruker BioSpin - NMR, EPR and Imaging 22 Jun 2021

First EUA point-of-care (POC/Waived/Fingerstick) COVID-19 antibody test now available from Carolina Liquid Chemistries.

The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, has received FDA Emergency Use Authorization for use.

From Carolina Liquid Chemistries Corp. 4 Nov 2020

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

As problems grow with Abbott’s fast COVID test, FDA standards are under fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

22 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

Ortho receives CE mark for COVID-19 IgG antibody test

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test received CE Mark. The test offers 100% specificity.

From Ortho-Clinical Diagnostics, Inc. 20 May 2020

Quest and Ortho Clinical Diagnostics join forces to expand COVID-19 antibody testing

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced it is working with Quest Diagnostics, the world's leading provider of diagnostic information services, to expand COVID-19 antibody testing to more than 20 Quest laboratories across the U.S.

13 May 2020

Ortho’s COVID-19 total antibody test receives CE Mark

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced its COVID-19 total antibody test received CE Mark.

From Ortho-Clinical Diagnostics, Inc. 13 May 2020

Ortho introduces second COVID-19 antibody test with 100% specificity

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today introduced and announced the U.S. Food and Drug Administration granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test. This test is one of only a handful of antibody tests to be granted Emergency Use Authorization.

From Ortho-Clinical Diagnostics, Inc. 29 Apr 2020

Abbott’s fast COVID test poses safety issues, lab workers say

Lab personnel say worries are mounting over the safety of a rapid coronavirus test by Abbott Laboratories that President Donald Trump has repeatedly lauded - particularly, the risk of infection to those handling it.

23 Apr 2020

GlobalData: Australia’s commitment to support clinical trial ecosystem will benefit medical device sector

Australia is dedicating more government funding towards the establishment of a vibrant clinical trial ecosystem in order to accelerate the design, development, verification and product launch processes of medical devices, says GlobalData, a leading data and analytics company.

9 Apr 2020

Siemens Healthineers releases test kit for coronavirus COVID-19

Siemens Healthineers announced today the availability of its molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease.

From Siemens Healthineers Point of Care Diagnostics 6 Apr 2020

UC San Diego partners with five leading diagnostics manufacturers to ramp up testing for COVID-19

Partnering with five leading in vitro diagnostics manufacturers, an interdisciplinary team of scientists and physicians at UC San Diego Health and University of California San Diego School of Medicine today announced that the UC San Diego Center for Advanced Laboratory Medicine is significantly ramping up testing for COVID-19, projecting a capacity to complete 1,000 to 1,500 tests per day within two to three weeks.

22 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