In Vitro Diagnostics News and Research

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Siemens Healthineers Announces FDA Emergency Use Authorization for CLINITEST® Rapid COVID-19 Antigen Self-Test

The CLINITEST Rapid COVID-19 Antigen Self-Test has received FDA EUA for unsupervised self-testing for the SARS-CoV-2 virus by individuals age 14 and older (or adult-collected samples from individuals ages 2-13).

From Siemens Healthineers 4 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 Group 22 Jun 2021

EKF globally launches STAT-Site® WB β-ketone and glucose handheld analyzer

EKF obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs

From EKF Diagnostics 16 Jun 2021

FDA reminds the public about the limitations of COVID-19 antibody

The following quote is attributed to Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

20 May 2021

Biognosys announces strategic agreement with Siemens Healthineers

Biognosys announces today that it has established a strategic agreement with Siemens Healthineers through its clinical laboratory in Berkeley, California.

From Biognosys 14 Apr 2021

FIND announces launch of a request for proposals to expand access to COVID-19 testing services

The Foundation for Innovative New Diagnostics (FIND) announced today the launch of a request for proposals (RFP) to accelerate the development, manufacturing, and market availability of accurate, affordable, quality-assured and easy-to-use SARS-CoV-2 self-tests for use in low- and middle-income countries (LMICs).

5 Apr 2021

FDA waiver broadens the use of chlamydia and gonorrhea test at more point-of-care settings

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

30 Mar 2021

Renalytix AI and University of Utah announce partnership to improve kidney health

Renalytix AI plc, an artificial intelligence-enabled in vitro diagnostics company, and the University of Utah, one of the top research institutions in the United States, today announced a partnership to improve kidney health and reduce the risk of kidney failure for large scale populations in the earliest stages of kidney disease.

25 Feb 2021

Tecan and UgenTec partner to offer sample-to-result solutions for qPCR

Tecan and laboratory software specialist UgenTec have announced a collaboration to develop fully integrated, sample-to-result solutions for PCR workflows.

From Tecan 9 Feb 2021

Increased access to testing, treatment has reduced hepatitis C in low- and middle-income countries

Many low- and middle-income countries have reduced suffering from hepatitis C, thanks to increased access to testing and treatment.

1 Feb 2021

New WHO essential diagnostics list expands the suite of tests to promote better health

To address the lack of access to tests and testing services in multiple countries, WHO since 2018 has published a yearly essential diagnostics list (EDL), a basket of recommended in vitro diagnostics that should be available at point-of-care and in laboratories in all countries to increase timely and life-saving diagnoses.

1 Feb 2021

Accurate quantitative COVID-19 antibody test kit by EKF

EKF Diagnostics, the global in vitro diagnostics company, announces that it has introduced one of the first tests to precisely measure levels of COVID-19 neutralizing antibodies in individuals.

From EKF Diagnostics 22 Jan 2021

EKF opens larger facility to increase production of key component for COVID-19 testing regime

EKF’s new facilities in Llandough, Cardiff, for the manufacture of PrimeStore® MTM viral transport media, enabling pathogenic samples to be collected and transported safely and easily in compliance with UN3373 packaging regulations.

From EKF Diagnostics 22 Jan 2021

World Health Organization issues notice for in vitro diagnostics users

Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2.

14 Dec 2020

Greensboro North Carolina Company’s Dedication to Ensuring Laboratories have COVID-19 Supplies Now Offers One-Stop-Shop for PCR Instruments, Extraction Systems and Kits, POC COVID-19 Test Kits, and Supplies.

GREENSBORO, NC — (November 20, 2020) – Greensboro-based, Carolina Liquid Chemistries Corp. (CLC) has been tirelessly working since the beginning of the COVID-19 outbreak to provide high-quality testing kits and instruments to healthcare providers and laboratories as quickly as possible.

From Carolina Liquid Chemistries Corp. 23 Nov 2020

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

Ortho announces new appointiments to Board of Directors

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that David B. Perez, an accomplished global medical device industry veteran, has been appointed as an independent member to its Board of Directors.

From Ortho-Clinical Diagnostics, Inc. 3 Sep 2020