Serology

Eurofins Technologies Serological Assays Demonstrate Ability to Identify Neutralizing Antibodies

Retrieved on: 
Thursday, August 27, 2020

Eurofins Technologies (Paris:ERF) recently launched multiple serological assay solutions to detect antibodies targeted against the Nucleocapsid protein of the novel Coronavirus.

Key Points: 
  • Eurofins Technologies (Paris:ERF) recently launched multiple serological assay solutions to detect antibodies targeted against the Nucleocapsid protein of the novel Coronavirus.
  • However, simple presence of antibodies in an individual does not guarantee immunity to further infections since only a fraction of antibodies provide the ability to neutralize the virus upon a second contact.
  • Currently, elaborate tests requiring high biological safety measures are required to identify these neutralizing antibodies.
  • Now, a study performed by Eurofins Ingenasa has demonstrated a direct correlation between Eurofins Technologies antibody detection assays and seroneutralization capability of the antibodies detected without the need to perform time-consuming and complex tests including high biological hazard.

Avero Diagnostics Expands COVID-19 Testing Capabilities with Launch of Serology Testing

Retrieved on: 
Tuesday, August 25, 2020

Avero Diagnostics , a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys Anti-SARS-CoV-2 antibody test.

Key Points: 
  • Avero Diagnostics , a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys Anti-SARS-CoV-2 antibody test.
  • As the medical and scientific communities work to understand and stop the spread of COVID-19, serological testing serves as a piece of the very complex puzzle, said Trae Mattison, MD, Managing Partner, Avero Diagnostics.
  • Avero Diagnostics CLIA-certified and CAP-accredited laboratory is using the Roche immunoassay for the qualitative detection of antibodies against SARS-CoV-2.
  • Avero Diagnostics vision is to lead the healthcare industry in the delivery of anatomic pathology, molecular pathology and genetic testing.

DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Chembio Diagnostics, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, August 12, 2020

Investors have until August 17, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until August 17, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • In light of the COVID-19 pandemic, Chembio focused on the development and commercialization of a serological or antibody test.
  • Chembios antibody test was one of the first antibody tests authorized by the U.S. Food and Drug Administration (FDA) during the COVID-19 public health emergency.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Precipio Launches Covid-19 Antibody Test in its CLIA laboratory

Retrieved on: 
Tuesday, August 4, 2020

NEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. ( NASDAQ: PRPO ), announced it has completed the internal validation of the FDA-approved COVID-19 serology antibody test in its CLIA laboratory, and has launched the test commercially to its pathology customer base (phase 1).

Key Points: 
  • NEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. ( NASDAQ: PRPO ), announced it has completed the internal validation of the FDA-approved COVID-19 serology antibody test in its CLIA laboratory, and has launched the test commercially to its pathology customer base (phase 1).
  • Physicians will be able to conduct a simple blood draw from each patient who wishes to be tested.
  • Precipio is currently able to process 1,000 tests per day, increasing testing capacity to 10,000 tests per day by the end of Q3-20 as demand grows.
  • Physicians and other non-medical groups wishing to utilize our rapid testing services may contact us at [email protected] , or by calling us at 203.787.7888.

Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test

Retrieved on: 
Tuesday, August 4, 2020

Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.2 This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.

Key Points: 
  • Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.2 This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.
  • Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individuals longer term immune response.
  • The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD.
  • For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers COV2T assay was the only test that met both sensitivity and specificity targets.9
    To learn more about antibody test offerings from Siemens Healthineers, visit https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-di... .

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Chembio, Casper, Endo International, and PlayAGS and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, July 29, 2020

In light of the COVID-19 pandemic, Chembio focused on the development and commercialization of a serological or antibody test.

Key Points: 
  • In light of the COVID-19 pandemic, Chembio focused on the development and commercialization of a serological or antibody test.
  • For more information on the Endo securities class action go to: https://bespc.com/ENDP-3
    PlayAGS is a designer and supplier of electronic gaming machines.
  • For more information on the PlayAGS class actin go to: https://bespc.com/AGS
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Chembio Investors: Class Action Lawsuit Filed To Recover Investment Losses

Retrieved on: 
Tuesday, July 28, 2020

Investors with losses of $1,000,000 or more are encouraged to contact the firm for a complimentary case evaluation, click here to submit your transaction information.

Key Points: 
  • Investors with losses of $1,000,000 or more are encouraged to contact the firm for a complimentary case evaluation, click here to submit your transaction information.
  • LOS ANGELES, July 28, 2020 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Chembio Diagnostic System, Inc. (Chembio or the Company) investors that acquired Chembio securities (NASDAQ: CEMI ) betweenApril 1, 2020 through June 16, 2020, inclusive (the "Class Period").
  • The complaint filed in this action alleges that defendants misled investors regarding the accuracy of the Company's Dual Path Platform ("DPP Test") COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies aided in determining current or past exposure to the COVID-19 virus.
  • The FDA further stated that:
    The Chembio antibody test was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency.

New Study Ranks Performance of Currently Available COVID-19 Antibody Tests

Retrieved on: 
Wednesday, July 15, 2020

Ann Arbor, MI, July 15, 2020 (GLOBE NEWSWIRE) -- A new peer-reviewed study by researchers at NSF International and Novateur Ventures finds significant variability in the accuracy of currently available COVID-19 antibody tests.

Key Points: 
  • Ann Arbor, MI, July 15, 2020 (GLOBE NEWSWIRE) -- A new peer-reviewed study by researchers at NSF International and Novateur Ventures finds significant variability in the accuracy of currently available COVID-19 antibody tests.
  • The urgent need for the development of antibody diagnostic tests in response to the COVID-19 pandemic has compelled regulatory bodies to implement emergency use authorization programs to expedite the commercialization process of these tests.
  • Published independent performance data of five CLIA (chemiluminescence immunoassay), 15 ELISA (enzyme-linked immunosorbent assay) and 42 RDT (rapid diagnostic test) antibody tests that are currently on the market were reviewed for this study to understand their limits and potential.
  • There are two major types of diagnostic technologies available to address this: molecular and antibody (sometimes called serological) tests.

Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test

Retrieved on: 
Thursday, July 9, 2020

SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

Key Points: 
  • SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.
  • The Diazyme IgG test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.
  • Diazyme has been at the forefront of the development effort to bring timely, high quality COVID-19 serology (antibody) tests during the public health emergency.
  • The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests.

The Forte Village season restarts: safety at the centre for a 'free' holiday

Retrieved on: 
Wednesday, July 1, 2020

These the key words for a holiday during the time of the coronavirus.

Key Points: 
  • These the key words for a holiday during the time of the coronavirus.
  • For its reopening for the 2020 season, the facility has in fact chosen to adopt a rigorous health protocol: all guests are given a serological test when they check-in.
  • "We want to assure guests that they are entering a true paradise on earth when the door to Forte Village opens.
  • New in 2020, will be the arrival of Dr Ursula Jacobs, a specialist in the strengthening of the immune system.