Development of COVID-19 tests

Todos Medical to Launch EUA Authorized cPass SARS-CoV-2 Neutralizing Antibody Kit Through Agreement with Fosun Pharma

Retrieved on: 
Monday, July 19, 2021

The Company is currently automating the EUA cPass test at itsCLIA/CAP laboratory, Provista Diagnostics (Provista), to add high-capacity neutralizing antibody testing to its test menu, and is ramping up its sales and marketing infrastructure.

Key Points: 
  • The Company is currently automating the EUA cPass test at itsCLIA/CAP laboratory, Provista Diagnostics (Provista), to add high-capacity neutralizing antibody testing to its test menu, and is ramping up its sales and marketing infrastructure.
  • Todos will also make cPass available for client labs to run on their automated equipment.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has been authorized only for the presence of total neutralizing antibodies against SARS-CoV-2, not for any other viruses or pathogens.

Avellino Surpasses Two Million COVID-19 Tests in United States

Retrieved on: 
Monday, June 28, 2021

Avellino Lab USA, Inc. (Avellino) today announced that more than two million of its SARS-CoV-2/COVID-19 tests (AvellinoCoV2) have now been performed in the United States.

Key Points: 
  • Avellino Lab USA, Inc. (Avellino) today announced that more than two million of its SARS-CoV-2/COVID-19 tests (AvellinoCoV2) have now been performed in the United States.
  • Avellino was one of the first private companies in the U.S. to receive an Emergency Use Authorization (EUA) from the FDA for AvellinoCoV2 in March 2020.
  • For both the AvellinoCoV2 and AvellinoCoV2-Respiratory tests, Avellino processes the tests in the companys high complexity CLIA-certified lab.
  • The lab can process tens of thousands of tests a day, with further plans to continually increase capacity.

FDA issues Emergency Use Authorization for CovAb™ SARS-CoV-2 Ab Test, the oral fluid rapid test for SARS-CoV-2 antibodies

Retrieved on: 
Thursday, June 24, 2021

CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization

Key Points: 
  • CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization
    CovAb is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA.
  • In addition to being rapid and noninvasive, the CovAb test has sensitivity of 97.6% and specificity of 98.8%.
  • The CovAb test was developed based on Diabetomics' expertise in oral fluid and autoantibody diagnostics developed for its core service areas of diabetes and fetal-maternal disease.
  • The CovAb test is available for sale through Diabetomics' subsidiary COVYDx, Inc.
    View original content to download multimedia: http://www.prnewswire.com/news-releases/fda-issues-emergency-use-authori...

GetMyDNA Receives EUA for Retail and Bulk Purchase of COVID-19 Test Home Collection Kit

Retrieved on: 
Friday, June 18, 2021

The GetMyDNA COVID-19 Test Home Collection Kit DTC is an FDA-authorized mail-in home collection test kit for COVID-19 and is available for individuals 18 years and older in all 50 U.S. states.

Key Points: 
  • The GetMyDNA COVID-19 Test Home Collection Kit DTC is an FDA-authorized mail-in home collection test kit for COVID-19 and is available for individuals 18 years and older in all 50 U.S. states.
  • A PCR test is a highly reliable, high-complexity laboratory test.
  • The test will be available for order online at getmydna.com at $99 a kit with free overnight shipping both ways, or for retailer/bulk purchase with customized solutions and pricing available.
  • GetMyDNA provides affordable and reliable diagnostic home-testing solutions backed by telemedicine across the U.S. GetMyDNA is currently focused on providing gold-standard PCR COVID-19 testing and results through their FDA-authorized COVID-19 Test Home Collection Kit DTC.

FDA Authorizes LetsGetChecked’s Home Collection Coronavirus (COVID-19) Test For Use on Minors

Retrieved on: 
Tuesday, June 15, 2021

Following the May 2020 FDA EUA for the LetsGetChecked Coronavirus (COVID-19) home collection test and the March 2021 FDA EUA for direct-to-consumer purchasing without a prescription, this updated authorization for minors will support a safe return to school, play, travel, and more.

Key Points: 
  • Following the May 2020 FDA EUA for the LetsGetChecked Coronavirus (COVID-19) home collection test and the March 2021 FDA EUA for direct-to-consumer purchasing without a prescription, this updated authorization for minors will support a safe return to school, play, travel, and more.
  • Using the companys end-to-end model, LetsGetChecked offers a FDA EUA authorized Coronavirus (COVID-19) home collection testing solution.
  • The Coronavirus (COVID-19) home collection test incorporates a nasal swab and PCR lab analysis with convenient and secure results in 24-72 hours after lab receipt.
  • The ability to test minors for Coronavirus using LetsGetCheckeds platform will provide parents and guardians increased peace of mind as the country reopens, and children gather in-person and return to the classroom.

Global COVID-19 Sample Collection Kits Market Report 2021-2028: Organizations Across the Globe are Developing Innovative Products for Sample Collection

Retrieved on: 
Thursday, May 6, 2021

For instance, in November 2020, ICMR introduced an ambulatory covid-19 RT-PCR lab at its facility.

Key Points: 
  • For instance, in November 2020, ICMR introduced an ambulatory covid-19 RT-PCR lab at its facility.
  • The government has also announced to establish more labs to boost COVID-19 testing.\nIn 2020, the swabs COVID-19 sample kits industry segment accounted for the largest share.
  • This high share is attributed to the reliance on several approved diagnostic products on the use of nasopharyngeal swabs.
  • For instance, in November 2020, U.S.-based company AnPac Bio-Medical announced the approval of its EUA-antibody test by the FDA for Roche\'s Elecsys Anti Sars-COV-2 test.\nPlayers and organizations across the globe are developing innovative products for sample collection.

Alercell to Distribute the Clip COVID Rapid Antigen Test

Retrieved on: 
Wednesday, April 28, 2021

b'BOZEMAN, Mont., April 28, 2021 /PRNewswire/ -- Alercell, announced today that it will begin distributing the Clip COVID Rapid Antigen Test, a revolutionary antigen analyzer along with its antigen COVID-19 test collection kits, across the U.Sthrough its network and partnerships.

Key Points: 
  • b'BOZEMAN, Mont., April 28, 2021 /PRNewswire/ -- Alercell, announced today that it will begin distributing the Clip COVID Rapid Antigen Test, a revolutionary antigen analyzer along with its antigen COVID-19 test collection kits, across the U.Sthrough its network and partnerships.
  • The Clip COVID Rapid Antigen Test received FDA Emergency Use Authorization in December 2020 for point-of-care use in CLIA laboratories including CLIA Waived Laboratories.\nAntigen tests are diagnostic tests that checks to see if you are infected with the coronavirus.
  • Antigen testing is designed to be quicker and simpler than other tests for the coronavirus and could be conducted at the point of care.
  • The company\'s smartphone-based rapid tests beginning with the Clip COVID Rapid Antigen Test offer digitally connected, highly accurate, and affordable testing or monitoring solutions for various types of pathogens, proteins, hormones, and other biomolecules in point-of-care, enterprise, and at-home settings.

LumiraDx Receives Reissued FDA Emergency Use Authorization for Its High Sensitivity, Rapid COVID-19 Molecular Lab Test

Retrieved on: 
Tuesday, April 13, 2021

In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.

Key Points: 
  • In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.
  • "\nSARS-CoV-2 RNA STAR Complete received an EUA from the FDA on October 14, 2020 and LumiraDx plans to complete the process to obtain CE Mark.
  • TheLumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes.
  • It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.\n'

LumiraDx Receives Reissued FDA Emergency Use Authorization for Its High Sensitivity, Rapid COVID-19 Molecular Lab Test

Retrieved on: 
Tuesday, April 13, 2021

In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.

Key Points: 
  • In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.
  • "\nSARS-CoV-2 RNA STAR Complete received an EUA from the FDA on October 14, 2020 and LumiraDx plans to complete the process to obtain CE Mark.
  • TheLumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes.
  • It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.\n'

Collection Sites Makes Affordable FDA EUA Approved COVID-19 At-Home Testing Available Nationwide

Retrieved on: 
Thursday, April 8, 2021

The at-home test kits are available for purchase without a prescription by individuals through nationwide retail partners and by schools and businesses directly through the Collection Sites website.

Key Points: 
  • The at-home test kits are available for purchase without a prescription by individuals through nationwide retail partners and by schools and businesses directly through the Collection Sites website.
  • Collection Sites test kits are developed by a leading infectious disease laboratory and are based on the FDA EUA authorized SARS-CoV-2 RT-PCR assay.
  • Collection Sites expert lab processing and testing fee of $89.99 can be covered by health insurance or credit card.
  • The company provides pop-up COVID-19 lab testing services, business-focused testing services, and at-home testing services, powered by CLIA-licensed laboratories.