Saliva testing

Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid(TM) Clinical Study Test Results

Thursday, July 22, 2021 - 2:24pm

Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.

Key Points: 
  • Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.
  • "We're excited to share our overall 264 test results from our Brazilian AcuVid Saliva / RT-PCR Test Clinical Study.
  • The additional 201 test results, on top of the initial 63, not only exceed FDA-EUA minimum requirements, but confirms the performance quality and ease-of-use of our AcuVid saliva test.
  • In fact, our complete AcuVid study achieved comparable, and in some cases, better performance results than other leading COVID-19 rapid antigen tests available on today's market," expressed Rob Fia, CEO of Therma Bright.

New COVID-19 Saliva Test Makes Testing Far Easier for All Ages

Wednesday, July 14, 2021 - 8:00am
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210714005243/en/
    New COVID-19 saliva test makes testing far easier for all ages.
  • The screening test is performed by inserting the tip of the VSS-GP test strip into the sample, providing a positive or negative result at 20 minutes.
  • (Photo: Business Wire)
    The Intelligent Fingerprinting COVID-19 tests easy saliva sample collection makes it particularly suitable for testing more vulnerable people and children.
  • The introduction of our new COVID-19 test involved rapid design, development and manufacture within the UK over a ten-month period.

Wren Laboratories Launches First Direct-to-Consumer Saliva COVID-19 PCR Test for Children Ages Five+ and Adults Just in Time for Back-to-School and Work

Wednesday, July 7, 2021 - 3:18pm

Wren has been offering one of the nation's most accurate saliva tests since October 2020.

Key Points: 
  • Wren has been offering one of the nation's most accurate saliva tests since October 2020.
  • The Wren PCR test is simple to use, has little room for error, requires just a teaspoon of saliva and does not need any invasive nasal swabbing or similar unpleasant collection approaches.
  • Saliva samples are collected in 2-3 minutes and Wren delivers digital results to the users and schools and workplaces within 24 hours of sample receipt.
  • Several education and community organizations have relied on Wren's PCR Saliva COVID tests throughout the past year including Independence Northwest and Children's Center of Hamden.

Co-Diagnostics, Inc Receives CE Marking for Direct Saliva SARS-CoV-2 Test

Friday, June 18, 2021 - 3:30pm

Co-Diagnostics believes that eliminating the extraction process has the potential to increase throughput and lower costs of not only COVID-19 testing, but also any other pathogen for which the Company develops a direct saliva test.

Key Points: 
  • Co-Diagnostics believes that eliminating the extraction process has the potential to increase throughput and lower costs of not only COVID-19 testing, but also any other pathogen for which the Company develops a direct saliva test.
  • We believe that the need for testing will especially persist in countries where vaccination rates lag substantially behind those of the United States.
  • "The direct saliva technical advance represents one of the important innovations that the Company has developed since the pandemic began.
  • Our unique CoPrimer technology utilized in this test design received initial patent protection in 2018, which was further strengthened by an additional patent last year.

Therma Bright Reports Performance of Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test from Brazilian Clinical Study

Thursday, June 17, 2021 - 10:05pm

Toronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the AcuVid COVID-19 Rapid Antigen Saliva Test and a progressive medical device technology company, is pleased to provide an update on the exceptional performance of its AcuVid COVID-19 Rapid Antigen Saliva Test's Brazilian Clinical Study, conducted in Minas Gerais, Brazil.

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the AcuVid COVID-19 Rapid Antigen Saliva Test and a progressive medical device technology company, is pleased to provide an update on the exceptional performance of its AcuVid COVID-19 Rapid Antigen Saliva Test's Brazilian Clinical Study, conducted in Minas Gerais, Brazil.
  • "The ongoing clinical study for our AcuVid COVID-19 Rapid Antigen Saliva Test has performed extremely well," expressed Therma's CEO Rob Fia.
  • Furthermore, Therma plans to continue the clinical study in Brazil beyond the initial requirements, should any regulatory body require additional test data of the AcuVid COVID-19 Rapid Antigen Saliva Test.
  • The AcuVid COVID-19 Rapid Antigen Saliva Test was specifically designed to allow individuals to 'self-collect' their own saliva in a collection tube.

Rover Labs Provides Saliva-based COVID-19 Testing to New York City Public Schools

Thursday, June 17, 2021 - 12:30pm

NEW YORK, June 17, 2021 /PRNewswire/ --Rover Labs, a diagnostics technology leader in end-to-end saliva testing, is providing saliva-based COVID-19 testing to approximately 50 New York City public schools during a two-month pilot program that began on June 1 using technology developed by Fluidigm Corporation (Nasdaq:FLDM).

Key Points: 
  • NEW YORK, June 17, 2021 /PRNewswire/ --Rover Labs, a diagnostics technology leader in end-to-end saliva testing, is providing saliva-based COVID-19 testing to approximately 50 New York City public schools during a two-month pilot program that began on June 1 using technology developed by Fluidigm Corporation (Nasdaq:FLDM).
  • New York City public schools have instituted mandatory random weekly testing in all reopened school buildings to ensure safer in-person learning.
  • Through a new pilot program, Rover Labs is testing students and staff in New York City public schools from all five boroughs with a saliva-based test that is turnkey, cost-effective, highly sensitive and seamless to implement.
  • Rover Labs' non-invasive saliva-based testing service enables scalable, simple high-volume sample collection providing a less expensive and more comfortable experience than traditional nasal swabs.

Naveris' New Saliva Test Detects Head and Neck Cancer

Wednesday, June 2, 2021 - 1:00pm

A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result.

Key Points: 
  • A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result.
  • The study results point to the potential for a significant improvement in early detection of the most common type of head and neck cancer, HPV-associated oropharyngeal squamous cell carcinoma.
  • Naveris patient-friendly saliva test has the potential to radically advance early detection of HPV-positive head and neck cancer, which has been growing rapidly among men in the United States.
  • NavDx is a liquid biopsy test that detects HPV-associated head and neck cancer earlier than is possible with imaging and is provided exclusively in the United States through the Naveris national reference CAP-accredited laboratory.

Therma Bright Provides Update on Brazilian Clinical Study

Thursday, May 27, 2021 - 12:00pm

Company advances final validation efforts of its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - May 27, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide the following update on its Brazilian clinical study of its innovative 15- minute COVID-19 antigen saliva test.
  • "This key clinical study requires that each tested participant take our AcuVid COVID-19 Rapid Antigen Saliva Test as well as a 24-hour RT-PCR test which will be used as the gold-standard comparator test," shared Rob Fia, Therma Bright's CEO.
  • It also requires our test solution to achieve a minimum of 30 positive and 30 negative specimens in the study.
  • The Company looks to provide a further update upon receipt of the clinical study results.

Therma Bright Secures Development and Manufacturing Partner for AcuVid(TM) COVID-19 Rapid Antigen Saliva Test

Friday, May 21, 2021 - 1:00pm

K-One MediTech To Begin Production of CE approved 15-Minute Antigen Test Solution

Key Points: 
  • Under this Agreement, K-One MediTech will act as the primary manufacturer in Asia to produce the AcuVid\xe2\x84\xa2 COVID-19 Rapid Antigen Saliva Test Kits.
  • Therma Bright will be able to add FDA Emergency Authorization Use (FDA-EUA) and Health Canada (HC) approved kits once regulatory approvals are secured.
  • "\nIn April 2020, immediately following the COVID-19 pandemic global lockdown, Therma Bright and its team of talented scientists began developing its AcuVid\xe2\x84\xa2 COVID-19 Rapid Antigen Saliva Test using lateral flow technology.
  • Now the AcuVid\xe2\x84\xa2 COVID-19 Rapid Antigen Saliva Test Kit is a much simpler, easy-to-use kit that will simplify the process for medical professionals and individuals administering or taking the AcuVid\xe2\x84\xa2 test, but it also has enabled the Company to significantly reduce its cost from the first prototype version.\nThe K-One MediTech development and manufacturing agreement will provide services which include development, designs, concepts, formula, and manufacturing process for Therma Bright\'s new AcuVid\xe2\x84\xa2 Covid-19 Rapid Antigen Saliva Test.

Salivary Bioscience Studies That Have Impact: Getting Back to Our ABCDs

Wednesday, May 12, 2021 - 1:20pm

"\nAlthough COVID-19 has dominated much of the story of saliva over the last year, the ABCD study is a reminder that Salivary Bioscience makes a positive impact outside of COVID-19.

Key Points: 
  • "\nAlthough COVID-19 has dominated much of the story of saliva over the last year, the ABCD study is a reminder that Salivary Bioscience makes a positive impact outside of COVID-19.
  • Baseline data, such as the association between body mass index and hormone levels, has already been generated from this study.
  • "Salimetrics is ready with the experience and the latest knowledge in salivary bioscience," says Dr. Gaitonde.
  • "\nSalimetrics\' assay kits and CLIA-certified testing services are used to measure salivary analytes related to stress, behavior and development, inflammation, sleep, reproduction, health and immune function.