The Department of Health and Human Services (HHS) will help fund development of two diagnostic tests that may detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in just one hour.
Separately, HHS Secretary Alex Azar designated Admiral Brett Giroir, MD, assistant secretary for health and head of the Public Health Service, to coordinate COVID-19 diagnostic testing efforts among Public Health Service agencies, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), as well as state and local public health authorities and private or public clinical laboratories.
The funding for the diagnostic tests comes from the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).
The funding is as follows:
· $679,000 to DiaSorin Molecular, Cypress, CA, to rapidly develop the Simplexa COVID-19 direct assay
· $598,000 to QIAGEN, Germantown, MD, to accelerate development of the QIAstat-Dx RPS2 test for COVID-19.
The companies will provide the remaining funds for developing their respective diagnostic tests, HHS said.
“Rapid diagnostic tests are critical in this public health response. We are working with the private sector at an urgent pace to make these tests available on as many diagnostic platforms as we can in the coming weeks,” said BARDA Director, Rick A. Bright.
DiaSorin Molecular’s test will use a nasopharyngeal (back of the nose and throat) swab from patients and is being designed for use with the company’s Simplexa Direct technology, a Food and Drug Administration ( FDA)-cleared platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests.
The COVID-19 test would run on DiaSorin’s LIAISON MDX instrument, which works in conjunction with LIAISON MDX Studio software. The COVID-19 test could potentially be ready within six weeks for Emergency Use Authorization (EUA) consideration by the U.S. Food and Drug Administration (FDA).
QIAGEN will develop a COVID-19 test, QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel. The device is used to run FDA-cleared tests for 21 respiratory pathogens. The COVID-19 test could be ready within 12 weeks for EUA consideration by the FDA.
