In Vitro Diagnostics News and Research

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FDA approves first companion diagnostic that uses liquid biopsy and NGS technology

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).

7 Aug 2020

FDA authorizes first two COVID-19 serology tests

Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual's blood.

1 Aug 2020

COVID-19 test kits offered by Carolina Liquid Chemistries granted FDA emergency use authorization

Carolina Liquid Chemistries, Corp., an innovative leader in clinical diagnostics and drug screening, is now offering test kits for COVID-19 that have been granted Emergency Use Authorization by the US Food and Drug Administration, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act.

From Carolina Liquid Chemistries Corp. 29 Jul 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

Ortho Clinical Diagnostics announces launch and availability of VITROS XT 3400 Chemistry System

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory solutions, today announced the launch and availability of the VITROS XT 3400 Chemistry System, which completes the company's VITROS XT Solutions, a comprehensive suite of solutions that help labs obtain consistently fast, accurate and reliable results.

From Ortho-Clinical Diagnostics, Inc. 27 Feb 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

A glance at Pittcon 2020 exhibitors

The Lee Company’s LPD Series variable volume dispense pumps are stepper motor driven, positive displacement pumps that are designed to meet the demands of modern-day applications: consistent long-term performance and reliability in a compact lightweight package.

From Pittcon 21 Feb 2020

EKF’s Hemo Control hemoglobin analyzer used to reduce anemia in South America

EKF Diagnostics, announces it is supporting the reduction of anemia in developing regions of South America through the use of its POC hemoglobin analyzers.

From EKF Diagnostics 29 Jan 2020

Hitachi’s diagnostic imaging business will strengthen Fujifilm’s product line, says GlobalData

Following the news that Japan’s Fujifilm Holdings Corp has agreed to acquire Hitachi Ltd.’s diagnostic imaging business for approximately JPY179bn (US$1.64bn); Rohit Anand, Practice Head of Medical Devices at GlobalData, a leading data and analytics company, offers his view.

2 Jan 2020