On Oct. 29, 2020, Emulate announced that it had entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration (FDA) to enable multiple studies across FDA offices in priority research areas, including programs to evaluate COVID-19 vaccines and understand human immune response against SARS-CoV-2, the virus that causes COVID-19.

Under the CRADA, the FDA will use a range of Organ-Chips from Emulate to study the safety, efficacy, and mechanisms of drugs regulated by the FDA. The initial studies use Organ-Chips—which are able to recreate the natural physiology of specific human tissues and organs—in areas where conventional cell culture and animal-based testing methods have limitations in reflecting human biology and disease mechanisms that are not yet understood, such as Alzheimer’s disease and COVID-19. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using the Liver-Chip.

The Lung-Chip study, which will be led by the FDA’s Center for Biologics Evaluation and Research (CBER), aims to address one of the most important questions regarding protective immunity against SARS‑CoV-2: why individuals experience a wide spectrum of disease severity and what constitutes a real protection against future infection. The Emulate human Lung-Chip offers the unique functionality of mechanical strain and dynamic fluid flow to recreate the microenvironment found in the human lung.