The U.S. Department of Health and Human Services (HHS) is backing the development of Hologic’s high-throughput coronavirus diagnostic, which it says will be able to process up to 1,000 samples per day and deliver results in under three hours.
The move comes amid heavy criticism of the U.S.' diagnostic response to the COVID-19 outbreak. Compared to the tens of thousands of assays run in other countries, the Centers for Disease Control and Prevention (CDC) has reported just over 8,500 specimens tested as of March 10.
That includes nearly 3,700 performed at the CDC itself and over 4,800 at other public health labs—the lion’s share within the past two weeks. However, it is unclear how those numbers translate to an exact, and lower, total of patients screened, with varying numbers of specimens being taken from each person.
Hologic’s molecular diagnostic test is the first COVID-19 product to be supported by the HHS’ Biomedical Advanced Research and Development Authority, also known as BARDA, and under a streamlined selection process through the Office of the Assistant Secretary for Preparedness and Response.
"Early, rapid diagnosis is essential for clinicians and their patients to treat infections appropriately and take immediate action to help mitigate the spread of COVID-19," BARDA Director Rick Bright said in an agency statement.
"While the Centers for Disease Control and Prevention and our nation's public health laboratories are making valiant efforts in testing and surveillance of coronavirus infections, these labs could become overwhelmed as the number of suspected cases grows,” Bright said. “Rapid, high-throughput tests are critical to provide quick results for more Americans and to aid the nationwide public health response."
The support includes $699,000 to accelerate Hologic’s development, which the company said should take “a matter of weeks” to complete. The hardware will then be submitted for FDA review and an emergency use authorization.
The test will run on the company’s Panther Fusion system, for which Hologic unveiled optional add-ons in early February to scale up its processing capacity and throughput. The system also includes FDA-cleared tests for other, more common respiratory infections.
Meanwhile, BARDA said it is accepting proposals for the advanced development of vaccines, therapeutics and other medical products for use against COVID-19—particularly ones built off of previously FDA-approved products, demonstrating compliant manufacturing capability and large-scale commercial infrastructure.