Lateral flow test

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.

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.

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.

Avacta Receives Clinical Validation of AffiDX SARS-CoV-2 Antigen Lateral Flow Test

Tuesday, April 20, 2021 - 10:48am

b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.

Key Points: 
  • b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.
  • These data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.\nThe clinical evaluation of Avacta\xe2\x80\x99s lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR.
  • Avacta\xe2\x80\x99s rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads.
  • The clinical data for Avacta\xe2\x80\x99s AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.\nDr Alastair Smith, Chief Executive of Avacta Group commented: \xe2\x80\x9cI am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX antigen test with lower viral loads of Ct>26 as well as with higher viral load samples.

Meridian Bioscience Announces FDA Submission for New Curian® Campy Assay

Thursday, April 1, 2021 - 2:00pm

CINCINNATI, April 01, 2021 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO) a leading global provider of diagnostic testing solutions and life science raw materials, today announced that it has made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for the Companys new Curian Campy assay.

Key Points: 
  • CINCINNATI, April 01, 2021 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO) a leading global provider of diagnostic testing solutions and life science raw materials, today announced that it has made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for the Companys new Curian Campy assay.
  • This assay is one of many assays in the pipeline that expands the Curian menu, continuing Meridians leadership in the gastrointestinal disease and lateral flow testing market.
  • Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of Campylobacter spp.
  • Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products.

Monocent Inc, Receives Authorization From COFEPRIS (Mexico) And INVIMA (Colombia), For Their US-Manufactured, CE Marked, Highly Accurate, Easy-To-Use, 15-Minute, COVID-19 Antigen Test; Paired With Rymedi's Technology Platform; Scaling US Manufacturing To

Wednesday, March 17, 2021 - 2:26pm

CHATSWORTH, Calif., March 17, 2021 /PRNewswire/ -- Monocent Inc., (Monocent) is pleased to announce the COFEPRIS authorization of their SARS-CoV2 Antigen Rapid test System for detection of COVID-19 infection.

Key Points: 
  • CHATSWORTH, Calif., March 17, 2021 /PRNewswire/ -- Monocent Inc., (Monocent) is pleased to announce the COFEPRIS authorization of their SARS-CoV2 Antigen Rapid test System for detection of COVID-19 infection.
  • The Monocent antigen test is a lateral flow test that provides results in just 15-minutes, without the use of any laboratory equipment.
  • The Monocent Antigen Test is one component of Monocent's comprehensive COVID-19 testing solution.
  • The test is paired with a complimentary, cutting-edge, HIPAA compliant technology platform, Rymedi.

Abingdon Health Plc signs distribution agreement with BioSure UK

Wednesday, March 10, 2021 - 9:10am

Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19.

Key Points: 
  • Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19.
  • Abingdon Health aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing.
  • Founded in 2008, Abingdon Health is headquartered in York, England.
  • Since launching in 2015, theBioSUREHIVSelf Testhas helped people throughout the UK and the world, to #knowyourstatus.

Avacta’s Rapid Antigen Test Is Confirmed to Detect SARS-CoV-2 New Variants

Monday, March 8, 2021 - 7:30am

Some of these variants are more infectious, and therefore more rapidly transmissible, and have the potential to become dominant strains.

Key Points: 
  • Some of these variants are more infectious, and therefore more rapidly transmissible, and have the potential to become dominant strains.
  • Avacta has carried out analytical tests with the spike proteins isolated from both the B117 and D614G variants, and has confirmed that its AffiDX SARS-CoV-2 rapid antigen lateral flow test detects both of these variants as well as the original strain.
  • We will continue to monitor the performance of the Affimer reagents with future dominant variants as they become available to us.
  • Disclaimer: AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test not currently for sale in the United States.

The Worldwide Point of Care/Rapid Diagnostics Industry is Projected to Reach $50.6 Billion by 2025 at a CAGR of 11.4% from 2020

Thursday, March 4, 2021 - 9:15pm

The global point of care diagnostics market size is projected to reach USD 50.6 billion by 2025 from USD 29.5 billion in 2020, at a CAGR of 11.4%.

Key Points: 
  • The global point of care diagnostics market size is projected to reach USD 50.6 billion by 2025 from USD 29.5 billion in 2020, at a CAGR of 11.4%.
  • Factors such as the technological advancements in point of care devices in the market are propelling the growth of the market.
  • The lateral flow assays segment accounted for the largest share of the point of care diagnostics market, by platform, in 2020.
  • The lateral flow assays segment accounted for the largest share of the point of care diagnostics market in 2020.

Global Lateral Flow Assays Market (2020 to 2025) - Evolving Applications of Lateral Flow Assays Present Opportunities

Thursday, February 25, 2021 - 7:00pm

Based on applications, the lateral flow assays market is broadly segmented into clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing.

Key Points: 
  • Based on applications, the lateral flow assays market is broadly segmented into clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing.
  • In the lateral flow assay kits & reagents by technique segment, sandwich assays holds the highest market share
    On the basis of technique, the lateral flow assay kits & reagents market is segmented into competitive assays, sandwich assays, and multiplex detection assays.
  • Based on sample type, the lateral flow assays market for clinical testing applications is segmented into blood, urine, saliva, and other samples.
  • North America is expected to account for the largest share of the global lateral flow assays market in 2019.