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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

Base Genomics launches and raises $11 million USD to progress development of its TAPS technology

Epigenetics company Base Genomics has launched with a team of leading scientists and clinicians to set a new gold standard in DNA methylation detection.

4 Jun 2020

Ferritin heavy chain protein shows promise as a potential SARS-CoV-2 vaccine or antiviral

A new study published on the online preprint server bioRxiv in May 2020 reports the construction and testing of a new ferritin-based antigen-bearing protein that has biological activity towards the ACE2 receptor. This could indicate its potential for development as a vaccine or antiviral.

28 May 2020

Simple salt solution can help transport COVID-19 samples to testing laboratories

In a new peer-reviewed study appearing in The Journal of Molecular Diagnostics, published by Elsevier, investigators report that a simple salt solution commonly found in hospitals and clinical laboratories, phosphate buffered saline (PBS), can be used as a medium to reliably transport coronavirus-contaminated specimens to the testing laboratory for periods of up to 18 hours, which is often needed in busy clinical settings.

27 May 2020

Novel microRNA biomarker could help detect lymph node metastases in pancreatic cancer patients

For years, surgeons have operated on pancreatic cancer patients to remove what they thought was a localized tumor only to discover that the disease had spread to other, inoperable parts of the body. Now, a City of Hope molecular scientist thinks he may have found a way to prevent ineffective surgeries and prolong the lives of these patients.

18 May 2020

Genomic sequences from all over the world help fight SARS-CoV-2

As the COVID-19 pandemic rages across the world, killing hundreds of thousands and infecting over 4.1 million, researchers are racing against time to understand the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 genome has now been sequenced in many different regions of the world, and researchers are collaborating by sharing information to better understand the make-up and mutations that the virus has undergone.

11 May 2020

AMP publishes evidence-based recommendations to standardize clinical genotyping tests for warfarin response

The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today published consensus, evidence-based recommendations to aid in the design, validation and interpretation of clinical genotyping tests for the prediction of warfarin response.

6 May 2020

AI-based technology could help accelerate clinical trials for glaucoma

The technology, supported by an artificial intelligence (AI) algorithm, could help accelerate clinical trials, and eventually may be used in detection and diagnostics, according to the Wellcome-funded study published today in Expert Review of Molecular Diagnostics.

4 May 2020

Horizon Discovery extends coverage of OncoSpan reference standards to FFPE and Liquid Biopsy

Horizon Discovery Group plc, today announced it has added two new sample formats to its cell-based OncoSpan reference standards for cancer diagnostic assays.

From Revvity 29 Apr 2020

New DNA test will improve tracking of Salmonella food-poisoning outbreaks

Researchers report an assay to detect serotypes of Salmonella, paving the way for rapid serotyping directly from specimens.

28 Apr 2020

Novel method may enable decentralized facilities to deliver faster COVID-19 test services

The COVID-19 pandemic has resulted in over 2.5 million confirmed cases worldwide and nearly over 170,000 deaths as of April 21 according to the World Health Organization.

23 Apr 2020

UK and US companies lag behind other nations in rolling out COVID-19 diagnostic tests

Nations with high rates of coronavirus testing such as South Korea and Germany are also leading the world in commercialising COVID-19 diagnostic tests - far outstripping the domestic UK and US diagnostic industries, new research shows.

22 Apr 2020

CRISPR technology mobilized for rapid COVID-19 diagnosis

A group of authors from the United States published a study in the scientific journal Nature Biotechnology in which they have described a CRISPR-Cas-based approach for rapid and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection – without the need for complex laboratory infrastructure.

20 Apr 2020

Nasal smear as screening test for allergic rhinitis

Stuffy noses, itching and fits of sneezing - 130 million people in Europe suffer from hay fever and other forms of allergic rhinitis. Until now, these conditions have typically been diagnosed using blood samples or skin prick tests.

17 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

Her genetic test revealed a microscopic problem — and a jumbo price tag

Michelle Kuppersmith, 32, feels great, works full time and exercises three to four times a week. So she was surprised when a routine blood test found that her body was making too many platelets, which help control bleeding.

31 Mar 2020

GlobalData: Thermo Fisher to be major player in COVID-19 diagnostic tests following acquisition of Qiagen

Thermo Fisher Scientific is expected to produce millions of coronavirus (COVID-19) diagnostic tests following the acquisition of Qiagen for an approximate transaction value of US$11.5bn per share, says GlobalData, a leading data and analytics company.

From Thermo Fisher Scientific Inc. 20 Mar 2020

Hackensack Meridian Health's CDI launches rapid response coronavirus test

Hackensack Meridian Health, New Jersey's largest and most comprehensive health network, is pleased to announce that the Center for Discovery and Innovation has created a test to dramatically reduce the time it takes for diagnosing COVID-19.

12 Mar 2020

New NGS technique offers quick, accurate diagnosis of sepsis

A report in the Journal of Molecular Diagnostics, published by Elsevier, describes a new technique that uses real-time next-generation sequencing to analyze tiny amounts of microbial cell-free DNA in the plasma of patients with sepsis, offering the possibility of accurate diagnosis of sepsis-causing agents within a few hours of drawing blood.

5 Mar 2020