Immunologic tests

Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device

Friday, June 11, 2021 - 9:10pm

Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy.

Key Points: 
  • Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy.
  • Sales of Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.
  • In addition to the Sofia Q, Quidel offers other rapid diagnostic instrumented systems, including Sofia 2, and Sofia.
  • Quidels Sofia assays for rapid antigen COVID-19 diagnosis include Sofia 2 SARS Antigen FIA and Sofia 2 Flu + SARS Antigen FIA, currently under EUA by the FDA.

Avacta Announces Registration of its AffiDX SARS-CoV-2 Antigen Lateral Flow Test in EU

Friday, June 11, 2021 - 12:25pm

Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.

Key Points: 
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • The product registration by a Competent Authority in the EU allows the Company to sell the product in the EU for professional use.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU.

SARS-CoV-2 Antibody Test Developed by Promega Receives CE Mark

Wednesday, June 9, 2021 - 12:00pm

A SARS-CoV-2 antibody test developed by Promega Corporation, the Lumit Dx SARS-CoV-2 Immunoassay, has received CE marking and is now available in Europe.

Key Points: 
  • A SARS-CoV-2 antibody test developed by Promega Corporation, the Lumit Dx SARS-CoV-2 Immunoassay, has received CE marking and is now available in Europe.
  • The novel bioluminescent immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum.
  • View the full release here: https://www.businesswire.com/news/home/20210609005062/en/
    The Lumit Dx SARS-CoV-2 Immunoassay by Promega has received CE marking.
  • The novel bioluminescent immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum.

LivFul and Global Access Diagnostics announce partnership for COVID-19 test kit distribution

Wednesday, June 9, 2021 - 11:14am

LIVERPOOL, England, June 9, 2021 /PRNewswire/ --LivFul and Global Access Diagnostics (GAD)today announced a new partnership to make a variety of diagnostic kits, starting with COVID-19 rapid antigen tests, available in Low to Middle Income Countries.

Key Points: 
  • LIVERPOOL, England, June 9, 2021 /PRNewswire/ --LivFul and Global Access Diagnostics (GAD)today announced a new partnership to make a variety of diagnostic kits, starting with COVID-19 rapid antigen tests, available in Low to Middle Income Countries.
  • This partnership will bring rapid antigen test kits to the market at an affordable price.
  • We are aligned in driving access to our COVID-19 antigen test for as many people as possible."
  • "LivFul was founded to expand health access with products that transform lives and business models that reach all people.

Integral Molecular Expands Partnership with Japan's Life Sciences Distributor Funakoshi to Provide Access to Antibody Specificity and Epitope Mapping Services

Tuesday, June 8, 2021 - 5:12pm

PHILADELPHIA, June 8, 2021 /PRNewswire/ -- Integral Molecular has expanded its partnership with Funakoshi, a leader in distributing life science research reagents and services, to be the exclusive provider of Integral Molecular's therapeutic antibody characterization technologies in Japan.

Key Points: 
  • PHILADELPHIA, June 8, 2021 /PRNewswire/ -- Integral Molecular has expanded its partnership with Funakoshi, a leader in distributing life science research reagents and services, to be the exclusive provider of Integral Molecular's therapeutic antibody characterization technologies in Japan.
  • The partnership will provide researchers with access to antibody characterization technologies optimized to deliver IND-ready results in as little as 4 weeks, including off-target specificity profiling using the Membrane Proteome Array and high-resolution epitope mapping using Shotgun Mutagenesis .
  • Detailed specificity and epitope analysis are critical for therapeutic antibody success and intellectual property protection.
  • "We have a long-standing partnership with Integral Molecular, having distributedtheir Lipoparticle products for more than 8 years," said Tetsuya Ikeda, President and CEO of Funakoshi.

MHRA Confirms Registration of Avacta’s AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

Monday, June 7, 2021 - 8:51am

Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that the MHRA has confirmed registration of Avactas AffiDX SARS-CoV-2 antigen lateral flow test allowing the Company to place the product on the market in the UK for professional use.

Key Points: 
  • Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that the MHRA has confirmed registration of Avactas AffiDX SARS-CoV-2 antigen lateral flow test allowing the Company to place the product on the market in the UK for professional use.
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported in April demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: I am delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test from the MHRA.

Altimmune Demonstrates Strong Neutralization of South African Variant in Preclinical Study of Intranasal AdCOVID™

Wednesday, May 26, 2021 - 12:00pm

The serum neutralizing antibody titers were determined using a live virus focus reduction neutralization titer (FRNT) assay with a 50% neutralization endpoint.

Key Points: 
  • The serum neutralizing antibody titers were determined using a live virus focus reduction neutralization titer (FRNT) assay with a 50% neutralization endpoint.
  • Importantly, AdCOVID also promoted a strong mucosal neutralizing response to the B.1.351 virus in the respiratory tract with bronchoalveolar lavages showing neutralization of the variant virus.
  • AdCOVID is a single-dose intranasal vaccine candidate for COVID-19 currently being evaluated in a Phase 1 clinical trial.
  • Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.

ProMIS Neurosciences initiates commercialization of COVID-19 serology assay

Tuesday, May 25, 2021 - 12:30pm

I am delighted to lead this opportunity on behalf of ProMIS Neurosciences, stated Owen Dempsey.

Key Points: 
  • I am delighted to lead this opportunity on behalf of ProMIS Neurosciences, stated Owen Dempsey.
  • Our initial focus will be on commercialization to the medical and public health community, vaccine developers, pharmaceutical companies, governmental agencies and other organizations.
  • This advanced serology test developed by ProMIS Neurosciences measures not only serum antibodies to SARS-CoV-2, the novel coronavirus causing COVID-19, but also their protective activity against infection.
  • Additional variants can be added to the assay as they are identified.The assay utilizes an advanced, high-throughput, sensitive and accurate surface plasmon resonance (SPR) technology as opposed to traditionalELISA (enzyme-linked immunosorbent assay) methods.

AvantGen receives an award from the NIH/RADx to commercialize its anti-SARS-CoV-2 nucleocapsid antibodies for ultra-high sensitivity lateral flow assay development

Tuesday, May 25, 2021 - 11:00am

A pair of the antibody clones has been evaluated extensively in a rapid lateral flow assay (LFA) format for the detection of SARS-CoV-2 N protein.

Key Points: 
  • A pair of the antibody clones has been evaluated extensively in a rapid lateral flow assay (LFA) format for the detection of SARS-CoV-2 N protein.
  • The LFA test can detect N protein in clinical samples (n=55; Ct values 14-38) with 100% sensitivity.
  • We are extremely pleased to see that our rapid test exhibits an ultra-high sensitivity similar to that of the CDCs PCR test.
  • With the funding from RADx, we look forward to the further development of rapid antigen tests with these antibodies.

eMed Donates 1,000 COVID-19 Rapid Antigen Tests for the Benefit of M-DCPS Students, Teachers and Families

Thursday, May 20, 2021 - 7:47pm

"Helping communities in need attain greater access to rapid antigen testing is part of the solution we can all contribute to as we move forward and transition into a post-pandemic \'transformed normal\'.

Key Points: 
  • "Helping communities in need attain greater access to rapid antigen testing is part of the solution we can all contribute to as we move forward and transition into a post-pandemic \'transformed normal\'.
  • "The distribution of these COVID-19 test kits will contribute to the wellbeing of our community and allow us to continue moving toward a sense of normalcy.
  • "This partnership provides an additional resource for supporting our students and families during such difficult times so that they can overcome this pandemic and return to normalcy.
  • We embrace quantitative medicine to deliver prescribed tests and treatments directly to patients, driving better and more cost-effective health outcomes.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/emed-donates-1-000-covid-19-rapi...\n'