Diagnostic Testing

AdvaMedDx member companies produce innovative, high quality in vitro diagnostic (IVD) tests performed in laboratories, at the hospital bedside, in doctors’ offices and other locations. They facilitate evidence-based medicine to enable early detection of disease, promote wellness, improve patient outcomes, and advance public health. They have a pivotal role in addressing COVID-19.

AdvaMedDx and its member companies are supporting the public health response to COVID-19 by working around the clock to produce commercially available diagnostic tests as quickly as possible. Manufacturers are also working in close cooperation with federal departments and agencies, including FDA, as well as state officials, to help get tests to areas where they are most needed.

In Vitro Diagnostic COVID-19 Emergency Use Authorized Tests

Many in vitro diagnostic (IVD) manufacturers have developed COVID-19 IVDs that have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. To learn more about these tests and their availability, please visit AdvaMedDx’s COVID-19 IVD EUA landing page that provides links to each manufacturer’s COVID-19 test portal.

Government Initiatives/Funding Opportunities

Biomedical Advanced Research and Development Authority (BARDA) – COVID-19 Medical Countermeasures Partnership Opportunities

BARDA is working with its partners to identify promising medical countermeasures and technologies to combat COVID-19 and is seeking information from stakeholders on available diagnostic technologies and other medical countermeasures in development that are relevant to addressing this outbreak. Over the past couple of months, BARDA has entered into a number of public-private partnerships with diagnostic developers to provide funding for COVID-19 assay development on existing instrument platforms and to provide technical support to get a FDA Emergency Use Authorization (EUA). They have also recently funded several POC and mobile testing technologies for serology testing as well. A full list of their COVID-19 medical countermeasures portfolio can be found here, and their recent award announcements can be found here. There are three ways your company or organization can partner with BARDA to fight the ongoing novel coronavirus outbreak. To learn more, click here.

NIH Rapid Acceleration of Diagnostics (RADx) ​

The NIH has launched a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies. With a $1.5 billion investment from federal stimulus funding, the Rapid Acceleration of Diagnostics (RADx) initiative will invest in early innovative technologies to speed development of rapid and widely accessible COVID-19 testing.  RADx will expand the Point-of-Care Technologies Research Network (POCTRN) and use flexible, rapid processes to infuse funding and enhance technology designs at key stages of development. To learn more, click here.

AdvaMedDx Webinar Recording & Slides

In Vitro Diagnostics (IVD) COVID-19 Testing: Supporting Patient Care and Protecting Public Health

Speakers:

  • Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers
  • Stephen Tang, PhD, President and CEO, OraSure Technologies
  • Alan Wright, MD, MPH, Chief Medical Officer, Roche Diagnostics
  • Susan Van Meter, Executive Director, AdvaMedDx
  • Sarah Killeen, VP Government Affairs, AdvaMed
  • Duane Wright, VP Government Affairs, AdvaMed



Additional Resources