Polymerase chain reaction

ZT Corporate Steps Up for Responsible Transition Back to Work with COVID-19 Testing for its Employees and Public Health Focused Reopening of Economy

Retrieved on: 
Monday, April 20, 2020

ZT Corporate is conducting testing in an effort to help drive private sector led solutions to transitioning through this crisis that focus on public health and responsibly reopening our economy and workforce.

Key Points: 
  • ZT Corporate is conducting testing in an effort to help drive private sector led solutions to transitioning through this crisis that focus on public health and responsibly reopening our economy and workforce.
  • Testing will be offered through an independent, third-party healthcare provider beginning April 20 and is voluntary for ZT Corporate employees across Houston, Southeast Texas, New York City, Arizona, Fort Walton Beach and Atlanta.
  • Employees will have the option to receive an FDA-approved COVID-19 molecular, polymerase chain reaction (PCR) test (diagnostic test for COVID-19).
  • We want to help our communities get tested, get healthy and help our economy responsibly get back to work.

GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

Retrieved on: 
Monday, April 20, 2020

GenoSensor Corporation has received FDA Emergency Use Authorization for the GS COVID-19 RT-PCR KIT.

Key Points: 
  • GenoSensor Corporation has received FDA Emergency Use Authorization for the GS COVID-19 RT-PCR KIT.
  • GenoSensor has been supporting researchers, educators, and laboratories since 2003 and is a member of the Arizona Bioindustry Association (AZBio).
  • We are grateful to the FDA for their assistance and for this Emergency Use Authorization.
  • The GenoSensor team has worked tirelessly to develop this test and obtain the FDA Emergency Use Authorization.

Vela Diagnostics receives BARDA funding to develop COVID-19 tests

Retrieved on: 
Monday, April 20, 2020

The ViroKeySARS-CoV-2 RT-PCR Testis a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.

Key Points: 
  • The ViroKeySARS-CoV-2 RT-PCR Testis a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.
  • "The funding from BARDA will enable Vela Diagnostics to increase the domestic and global testing capacity for COVID-19 to curb further spread of the virus."
  • "Rapid diagnostic tests put essential information into the hands of healthcare providers and patients to manage patient care safely and appropriately.
  • Vela Diagnostics is a leading provider of an automated IVD NextGeneration Sequencing (NGS) workflow in the global diagnostics market.

Vela Diagnostics receives BARDA funding to develop COVID-19 tests

Retrieved on: 
Monday, April 20, 2020

The ViroKeySARS-CoV-2 RT-PCR Testis a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.

Key Points: 
  • The ViroKeySARS-CoV-2 RT-PCR Testis a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.
  • "The funding from BARDA will enable Vela Diagnostics to increase the domestic and global testing capacity for COVID-19 to curb further spread of the virus."
  • "Rapid diagnostic tests put essential information into the hands of healthcare providers and patients to manage patient care safely and appropriately.
  • Vela Diagnostics is a leading provider of an automated IVD NextGeneration Sequencing (NGS) workflow in the global diagnostics market.

Developer of PharmaCyte Biotech’s COVID-19 Test Explains Why His Test Is So Highly Sensitive, Path to FDA EUA, and Commercialization

Retrieved on: 
Monday, April 20, 2020

As well as tests that are done in laboratories, some antibody-based tests are point-of-care kits or even home kits.

Key Points: 
  • As well as tests that are done in laboratories, some antibody-based tests are point-of-care kits or even home kits.
  • Professor Yu: The test developed for detecting SARS-CoV-2 is the Enhanced Real-Time PCR (ERT-PCR) method.
  • This means test results are positive only if the SARS-CoV-2 target sequences are present in the test sample.
  • The pooling strategy expedites the screening process for which the accuracy can be ensured by the highly sensitive ERT-PCR test method.

BGI Group Provides Support for Timely COVID-19 Detection and Intervention across Europe

Retrieved on: 
Monday, April 20, 2020

All of the MGI instruments and extraction kits, the swabs, and the BGI Genomics RT-PCR test for SARS-CoV-2 have received the CE-IVD mark.

Key Points: 
  • All of the MGI instruments and extraction kits, the swabs, and the BGI Genomics RT-PCR test for SARS-CoV-2 have received the CE-IVD mark.
  • "The most critical thing for all of us at BGI is to help bring this pandemic under control.
  • We are working with governments and institutions globally to achieve this mission," says Yin Ye, CEO of BGI Genomics.
  • In Sweden, researchers in genomics at the Karolinska Institutet have been working closely with BGI Group for over a decade.

Fosun Pharma Receives FDA Emergency Use Authorization (EUA) For Its COVID-19 RT-PCR Detection Kit

Retrieved on: 
Sunday, April 19, 2020

SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for itsCOVID-19 RT-PCR detection kit.

Key Points: 
  • SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for itsCOVID-19 RT-PCR detection kit.
  • The testing kit which was self-developed by Fosun Long March, a wholly-owned subsidiary of Fosun Pharma, has received the medical device registration certificate issued by the China National Medical Products Administration (NMPA) and granted CE certification from the European Union ("EU").
  • Fosun Pharma has been engaged in the business of PCR hepatitis B virus diagnostic reagents since its establishment in 1994.
  • According to the company's FY2019 earnings results, the revenue of Fosun Pharma increased by 14.72% to RMB28,585million as compared to 2018.

Outlook on the Worldwide Molecular Point of Care Industry to 2024 - Market Sizing, Forecasting, Trend Mapping and Competitive Analysis - ResearchAndMarkets.com

Retrieved on: 
Friday, April 17, 2020

The "The Market and Future Potential for Molecular Point of Care" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Market and Future Potential for Molecular Point of Care" report has been added to ResearchAndMarkets.com's offering.
  • This report provides market sizing, forecasting, trend mapping and competitive analysis for point of care tests using PCR or other molecular technology with fast turnaround times and usability in near-patient settings.
  • Molecular point of care or mPOC systems are designed to be faster than lab-based tests while more accurate than existing point of care systems.
  • The market is by no means stable; there is still heavy competition and a need to justify purchases to providers.

Igenomix launches COVID-19 RT-PCR Test and introduces a new Biological Passport for a COVID-19 free society

Retrieved on: 
Friday, April 17, 2020

This test, already available, combined with a COVID-19 Antibody Test, will make up the Igenomix Biological Passport, a service that will allow for organizations to plan for a safe return to the workplace.

Key Points: 
  • This test, already available, combined with a COVID-19 Antibody Test, will make up the Igenomix Biological Passport, a service that will allow for organizations to plan for a safe return to the workplace.
  • The SARS-CoV-2 RT-PCR (Real-time Reverse Transcription Polymerase Chain Reaction) Test is a diagnostic test designed to confirm if an individual is currently infected.
  • Samples are to be collected by health specialists using nasopharyngeal swabs and processed inIgenomix labs under the FDA Emergency Use Authorization (EUA).
  • All Igenomix labsare certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.

Kaneka Agrees to Supply Active Pharmaceutical Ingredients for Avigan® Tablet

Retrieved on: 
Thursday, April 16, 2020

TOKYO, April 16, 2020 /PRNewswire/ -- Kaneka Corporation (President: Minoru Tanaka) has reached an agreement with FUJIFILM Corporation (President: Kenji Sukeno) to supply drug substances for anti-influenza drug, Avigan Tablet (generic name: favipiravir), for the novel coronavirus disease (referred to below as COVID-19).

Key Points: 
  • TOKYO, April 16, 2020 /PRNewswire/ -- Kaneka Corporation (President: Minoru Tanaka) has reached an agreement with FUJIFILM Corporation (President: Kenji Sukeno) to supply drug substances for anti-influenza drug, Avigan Tablet (generic name: favipiravir), for the novel coronavirus disease (referred to below as COVID-19).
  • While COVID-19 continues to spread, the Japanese government has decided to increase its stockpiles of Avigan Tablet, which is expected to be effective against COVID-19, for up to 2 million people, and FUJIFILM Corporation has expanded its production system and started increasing its production of Avigan Tablet.
  • We have already started supplying PCR reagents used for COVID-19 tests via our group company Kaneka Eurogentec (Headquarters: Belgium).
  • Kaneka will put in every effort to provide solutions to the COVID-19 for worldwide health.