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Weekly COVID-19 Update: COVID Test Milestone, and Updates on an Investigational Vaccine

12/21/2020

The ANSI Federation and standardization community are stepping up with guidance, resources, and initiatives to support public health, safety, and infrastructure during the COVID-19 outbreak. Suggestions for news items may be submitted to [email protected]. All submissions are published at ANSI's discretion.

Advamed Reveals MedTech Industry Has Shipped More Than 255 Million Molecular COVID-19 Tests Nationwide

AdvaMed reports that its COVID-19 Diagnostic Supply Registry shows that total U.S. shipments of COVID-19 molecular diagnostic tests have topped more than 255 million since the beginning of the pandemic. The registry, which has information since July, compiles information from leading diagnostics companies along with publicly available data on daily tests performed to create a centralized and standardized COVID-19 diagnostic supply registry. The registry, which includes weekly reporting since July 24, 2020, also provides weekly state- and national-level updates on the number of molecular and serology (antibody) tests shipped in the U.S. to help state and federal governments in their pandemic responses.

“As we head into winter weather and flu season, our diagnostics innovators have continued ramping up their COVID-19 test manufacturing to save lives,” said Scott Whitaker, president and CEO of AdvaMed. “More than 255 million molecular COVID-19 tests shipped since March is a big milestone. Added context makes a big milestone even more significant: These tests represent the ability to more quickly administer treatment plans for Americans who test positive, and better contact-tracing opportunities for American communities. Bottom line, these tests bring our country another step closer to getting this pandemic under control. Our diagnostics innovators won’t stop until we get there.”

Read more about the registry on Advamed's website.

Johnson & Johnson Seeks Volunteers for Investigational Vaccine

Johnson & Johnson has announced that it is seeking volunteers from diverse groups to research an investigational vaccine. The purpose of the "ENSEMBLE" clinical research studies is to determine the safety and efficacy (whether it works) of an investigational vaccine for the prevention of COVID-19. The investigational vaccine is being evaluated in people 18 years of age or older. The company reports that those who qualify may receive:

  • study-related medical care from local doctors at no cost
  • the investigational vaccine or placebo at no cost
  • reimbursement for reasonable trial-related travel expenses

Access more information via https://www.jnj.com/.

See more ANSI member efforts in the ANSI COVID-19 Resource Webpage Highlighting Standardization Community Response

 

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