Immunologic tests

Auris Medical Announces Publication of Data from Preclinical Studies with Bentrio™ Nasal Spray in Prevention and Mitigation of SARS-CoV-2

Retrieved on: 
Wednesday, July 14, 2021

AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation.

Key Points: 
  • AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation.
  • The manuscript describing these preclinical data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2021.07.12.452021v1 and will undergo scientific peer-review for potential publication.
  • As recently announced, Auris Medicals affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio by launching it in Germany.
  • Bentrio (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens.

COVID-19: Doctor's certificates for antigen self-tests now offered online worldwide by DrAnsay.com

Retrieved on: 
Thursday, July 8, 2021

HAMBURG, Germany, July 8, 2021 /PRNewswire/ -- DrAnsay.com, the market leader for online doctor attests, now offers online test certificates for self-applied rapid antigen tests worldwide to avoid the effort, infection risk and cost of point-of-care testing.

Key Points: 
  • HAMBURG, Germany, July 8, 2021 /PRNewswire/ -- DrAnsay.com, the market leader for online doctor attests, now offers online test certificates for self-applied rapid antigen tests worldwide to avoid the effort, infection risk and cost of point-of-care testing.
  • To obtain a test certificate online, the user first needs a standard antigen rapid self-test, which he performs himself at any time at any location.
  • Within three minutes he will receive the test certificate in 14 languages as a PDF file 24/7 after verification by an online doctor.
  • Only our efficient online service now quickly and easily allows millions of doctors' certificates of such self-applied tests worldwide," said lawyer and CEO Dr. jur.

COVID-19: Doctor's certificates for antigen self-tests now offered online worldwide by DrAnsay.com

Retrieved on: 
Thursday, July 8, 2021

HAMBURG, Germany, July 8, 2021 /PRNewswire/ -- DrAnsay.com, the market leader for online doctor attests, now offers online test certificates for self-applied rapid antigen tests worldwide to avoid the effort, infection risk and cost of point-of-care testing.

Key Points: 
  • HAMBURG, Germany, July 8, 2021 /PRNewswire/ -- DrAnsay.com, the market leader for online doctor attests, now offers online test certificates for self-applied rapid antigen tests worldwide to avoid the effort, infection risk and cost of point-of-care testing.
  • To obtain a test certificate online, the user first needs a standard antigen rapid self-test, which he performs himself at any time at any location.
  • Within three minutes he will receive the test certificate in 14 languages as a PDF file 24/7 after verification by an online doctor.
  • Only our efficient online service now quickly and easily allows millions of doctors' certificates of such self-applied tests worldwide," said lawyer and CEO Dr. jur.

Lateral Flow Assays Markets, 2027 by Product (Kits, Readers), Technique (Sandwich, Competitive, Multiplex), Application (Clinical, Food Safety, Drug Development, Veterinary) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 7, 2021

The "Lateral Flow Assays Market by Product (Kits, Readers), Technique (Sandwich, Competitive, Multiplex), Application (Clinical [Pregnancy, Infectious Diseases], Food Safety, Drug Development, Veterinary), and End User (Hospitals, Home Care) - Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Lateral Flow Assays Market by Product (Kits, Readers), Technique (Sandwich, Competitive, Multiplex), Application (Clinical [Pregnancy, Infectious Diseases], Food Safety, Drug Development, Veterinary), and End User (Hospitals, Home Care) - Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.
  • The lateral flow assays market is expected to grow at a CAGR of 8.8% from 2020 to 2027 to reach $13.85 billion by 2027.
  • In addition, continuous advancements in lateral flow assays are also expected to contribute to the growth of this segment.
  • North America commanded the largest share of the lateral flow assays market in 2020, followed by Europe and Asia-Pacific.

Avacta Announces AffiDX® SARS-CoV-2 Antigen Lateral Flow Test Detects Delta Variant

Retrieved on: 
Tuesday, June 29, 2021

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 a study has shown that the AffiDX antigen lateral flow test detects the Delta variant of the SARS-CoV-2 virus in clinical samples and, in this small study, outperformed two lateral flow antigen tests that are commercially available in Europe.

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 a study has shown that the AffiDX antigen lateral flow test detects the Delta variant of the SARS-CoV-2 virus in clinical samples and, in this small study, outperformed two lateral flow antigen tests that are commercially available in Europe.
  • The AffiDX SARS-CoV-2 antigen lateral flow test has been evaluated with a small number of patient samples confirmed to be Delta variant positive and, for a Ct
  • The AffiDX SARS-CoV-2 antigen lateral flow test is CE marked for professional use in the UK and EU.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to report that the AffiDX SARS-CoV-2 antigen lateral flow test detects the Delta variant with very high sensitivity for patients with a Ct value of less than 29.

Avacta Announces AffiDX® SARS-CoV-2 Antigen Lateral Flow Test Distribution Agreement

Retrieved on: 
Monday, June 21, 2021

The non-exclusive distribution agreement for Avactas AffiDX SARS-CoV-2 antigen lateral flow test for professional use covers the UK and EEA.

Key Points: 
  • The non-exclusive distribution agreement for Avactas AffiDX SARS-CoV-2 antigen lateral flow test for professional use covers the UK and EEA.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted that we have put in place this distribution agreement for the AffiDX SARS-CoV-2 antigen lateral flow test for professional use with Calibre.
  • Avacta will continue to focus on developing direct sales opportunities to major corporates and other large scale end users.
  • Lateral flow tests have a crucial role to play in helping societies and the global economy return to normal and Avactas AffiDX antigen test, developed in the UK and based on UK technology is well placed to play a significant role in this process.

Duke-NUS and GenScript Announce Notice of Allowance for U.S. Patent Application for SARS-CoV-2 Surrogate Virus Neutralization Test

Retrieved on: 
Monday, June 21, 2021

Neutralizing antibodies have been scientifically shown to play a major role in preventing infection by blocking a virus from infecting cells.

Key Points: 
  • Neutralizing antibodies have been scientifically shown to play a major role in preventing infection by blocking a virus from infecting cells.
  • Developed by Professor Linfa Wang and his team from Duke-NUS,the sVNT neutralization antibody detectiontechnology is exclusively licensed to GenScript for commercializationas the cPass SARS-CoV-2 Neutralization Antibody Test.
  • "GenScript is honored to have been involved in the R&D and commercialization of the cPass kit.
  • The cPass test is a safer, faster, easier and more consistent alternative to the traditional live virus- or cell-based tests, with comparable specificity and sensitivity.

Malaysia Permission Granted for COVID-19 Test Kit from China for Emergency Use; Homegrown Holista Colltech Receives Initial Order for 15,000 Units for Deployment

Retrieved on: 
Friday, June 18, 2021

With this approval, the Company has secured an initial order for 15,000 units in Malaysia.

Key Points: 
  • With this approval, the Company has secured an initial order for 15,000 units in Malaysia.
  • MOH's Medical Devices Authority ("MDA") has granted Holista permission to import and distribute up to 45,000 units of the Hecin antigen test kit for emergency use within three months from the date of approval on 14th June 2021.
  • The clinical performance of Hecin RTK-Antigen test kit against PCR Comparator method using nasopharyngeal swabs specimens has obtained a sensitivity of 96.23% and specificity 99.07%.
  • Holista CollTech Ltd ("Holista") is a natural wellness company with the following divisions:

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

Retrieved on: 
Friday, June 11, 2021

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

Retrieved on: 
Friday, June 11, 2021

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.