GenBody  

3420 De Forest Circle
Jurupa Valley,  CA  91752

United States
https://genbodyamerica.com

• Booth: 3231

GenBody is a diversified manufacturer of diagnostic tests for over 78 human diseases. GenBody specializes in developing monoclonal antibodies and recombinant antigens in-house at our facility in South Korea. Recently, the US FDA granted Emergency Use Authorization to GenBody's COVID-19 Ag point-of-care antigen test for SARS-CoV-2 infection. The test can be performed by a healthcare professional and an at-home test is in development for future use. Earlier this year, GenBody received a US National Institutes of Health contract for the US production of a visually read, single lateral flow rapid test system for SARS-CoV-2. Located in Jurupa Valley, California, the US factory is expected to be complete in Q3 2021. GenBody is rapidly expanding its footprint in the US. For inquiries regarding opportunities to join our team, please call 949-561-0664 or jobs@genbodyamerica.com. For partnership opportunities, call 949-561-0664 or email partnerships@genbodyamerica.com.

 Videos

 Press Releases

• GenBody Rapid Antigen Test Is Added to Growing Lineup of COVID-19 Diagnostic Testing (Jul 30, 2021)

  GenBody COVID-19 Ag Test expands access to point of care testing with results in 20 minutes or less

  The FDA has authorized the GenBody COVID-19 Ag test for Emergency Use Authorization for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

  Kwell Laboratories is the exclusive U.S. distributor for GenBody, Inc. GenBody, established in 2012, is a leading South Korean manufacturer of rapid diagnostic kits and reagents for point of care applications for COVID-19 and other diseases.

  “GenBody has made easy to use and accurate COVID-19 testing available globally and we are pleased to now bring this advanced South Korean technology to the U.S.” shared the CEO of GenbBdy Inc. Dr. James Chong. “The need for fast and affordable rapid test kits is especially strong now that we are seeing a rise in COVID-19 outbreaks due to variants and as the U.S. continues to open up. We are excited to offer this highly effective test to the US and we are looking forward to bringing additional product releases.” stated David Yoo, CEO of Kwell Laboratories.

  GenBody, in partnership with Kwell Laboratories, was awarded a National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative award of an estimated $10 million in support of U.S. production of GenBody's innovative point of care test that will increase the capacity of fast, affordable and easy to use testing in the U.S. An at-home test is also in development for future use.

  About GenBody:
  Founded in 2012, GenBody creates innovative technologies for diagnostic tests globally. GenBody manufactures 85 kinds of rapid diagnostic tests for human and veterinary use including influenza A/B ag, strep A ag, mycoplasma Ag, Zika, Dengue, cardiac marker and cancer marker. GenBody is a vertically integrated manufacturer of rapid Covid-19 Ag from its in-house monoclonal antibody production to final assembly of the testing device.

  This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00007.

• FDA Grants Emergency Use Authorization for GenBody Point-of-Care SARS-CoV-2 Antigen Test (Aug 06, 2021)

  NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization to GenBody's COVID-19 Ag point-of-care antigen test for SARS-CoV-2 infection.

  The immunochromatographic rapid diagnostic test is designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab specimens.

  It is authorized for use by any lab CLIA-certified to perform moderate-, high-, or waived-complexity tests. It may also be used in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, the FDA said.

  Earlier this year, South Korea-based GenBody received a US National Institutes of Health contract to develop a visually read, single lateral flow rapid test system for SARS-CoV-2.

• RADxSM Tech and ATP Programs: Phase 2 Awards (Aug 06, 2021)

  The NIH Rapid Acceleration of Diagnostics (RADxSM) Initiative aims to accelerate the development and commercialization of diagnostic tests to detect the SARS-CoV-2 virus.  Two RADxSM programs within this Initiative—RADxSM Tech and RADxSM ATP (Advanced Technology Platforms) —are supporting late stage development of innovative point-of-care and home-based tests, as well as improved clinical laboratory tests that will increase the capacity of testing in the U.S.

  GenBody Inc.

  Project Title:

  U.S. regulatory approval and mass production of rapid antigen testing kit for detecting SARS-CoV-2

  Project Description:

  A visually read, single lateral flow rapid test system capable of detecting the SARS-CoV-2 that can deliver results within 20 minutes. The test can be performed by a healthcare professional and an at-home test is in development for future use.

  Estimated Budget:$10,000,000

• GenBody’s Covid-19 antigen rapid test kit wins FDA emergency use nod (Aug 06, 2021)

  Diagnostic solution provider GenBody said Thursday that it has won the emergency use authorization (EUA) for its Covid-19 antigen rapid test kit, GenBody COVID-19 Ag, from the U.S. Food and Drug Administration.
   

  GenBody was selected by the U.S. National Institute of Health (NIH) as the developer of its Rapid Acceleration of Diagnostics (RADx) program in March. NIH provided funding for each stage of the project totaling $10 million, and the EAU is one of its interim results, GenBody said.
  
  RADx is a research and development project of NIH to speed up authorization, production, and supply of test kits amid the spread of Covid-19.
  
  GenBody plans to complete the construction of its manufacturing plant in California by September. In addition, the company is installing an automated production facility and securing Good Manufacturing Practices (GMP) certificate at the plant.
  
  With samples collected from the nasal cavity and throat with a swab, GenBody COVID-19 Ag provides test results within 15 minutes. The rapid test kit was also assessed in Korea and by Emory University in the U.S., which checked its capabilities to detect coronavirus variants like Alpha, Beta, Delta, and Gamma.
  
  “We are glad to contribute to overcoming the Covid-19 pandemic with our rapid test kit,” said Chong Chom-kyu, chief technology officer of GenBody, “To improve the competitiveness of GenBody COVID-19 Ag, we will gather data on the accuracy of the test kit through ongoing clinical trials. Also, we will do our best to ensure its stable supply.”
  
  Besides, GenBody attained approval from the Ministry of Food and Drug Safety for HelicoSign Dry in June. HelicoSign Dry is a dry diagnostic agent that tests infection of helicobacter pylori.
  
  GenBody produces test kits and equipment for humans and animals and exports its products to about 50 countries, including Brazil, China, and Indonesia. It was the first company to develop the rapid test kit for the Zika virus in 2016.
  

  KBR(http://www.koreabiomed.com)

• Project N95 Adds GenBody Rapid Antigen Test to Growing Lineup of COVID-19 Diagnostic Testing (Sep 13, 2021)
  BROOKLYN, NY, UNITED STATES, September 8, 2021 /EINPresswire.com/ -- Project N95 – a nonprofit, 501(c)(3) organization – is adding GenBody's innovative and affordable COVID-19 Ag point of care test to its suite of products. The GenBody COVID-19 Ag test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
  
  Since launching in 2020, Project N95 has provided more than 10 million units of personal protective equipment (PPE) throughout the United States. This led to the protection of hundreds of thousands of workers in hospitals, long-term care facilities, and other healthcare centers during the COVID-19 pandemic. After adding COVID-19 testing to its product offerings in early 2021, the organization has continued to innovate to open access and provide critical equipment where it is needed most.
  
  “The addition of the GenBody COVID-19 Ag test to the Project N95 Shop continues to change the game by improving access to accurate, rapid testing options,” explained Geoff Bonn, chief financial officer at Project N95. “We’re excited to offer this highly effective test to our community, and we are looking forward to the upcoming product releases GenBody has planned.”
  
  GenBody was awarded a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative award of an estimated $10 million in support of U.S. production of GenBody's innovative point of care test that will increase the capacity of fast, affordable and easy to use testing in the U.S. An at-home test is also in development for future use.
  
  GenBody, established in 2012, is a leading South Korean manufacturer of rapid diagnostic kits and reagents for point of care applications for COVID-19 and other diseases.
  
  “Genbody has made easy to use and accurate COVID-19 testing available globally and we are pleased to now bring this advanced South Korean technology to the U.S.” shared the CEO of Genbody Inc. Dr. James Chong. “The need for fast and affordable rapid test kits is especially strong now that we are seeing a rise in COVID-19 outbreaks as the U.S. continues to open up,” stated David Yoo, CEO of Kwell Laboratories.
  
  As a mission-driven nonprofit, Project N95 makes it possible for everyone to access personal protective equipment and COVID-19 tests from a trusted source. To find the GenBody COVID-19 Ag test and other critical supplies such as N95 respirators, surgical masks and a variety of COVID-19 tests, visit shop.projectn95.org.
  
  
  About Project N95:
  Project N95 protects communities and the people who live and work in them by providing equitable access to the resources they need to stay safe through the COVID-19 pandemic. As a leading rapid response nonprofit organization created in response to the pandemic, Project N95 has delivered more than 10 million units of personal protective equipment since May 2020, becoming the National Clearinghouse for critical PPE and diagnostic tests. Visit www.projectn95.org to learn more or to volunteer.
  
  About GenBody:
  Founded in 2012, GenBody creates innovative technologies for diagnostic tests globally. GenBody manufactures 85 kinds of rapid diagnostic tests for human and veterinary use including influenza A/B ag, strep A ag, mycoplasma Ag, Zika, Dengue, cardiac marker and cancer marker. GenBody is a vertically integrated manufacturer of rapid Covid-19 Ag from its in-house monoclonal antibody production to final assembly of the testing device.
  
  This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00007.

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