HHS Provides Development Support for COVID-19 Diagnostic; Seeks Product InnovationBy
In response to the novel coronavirus (COVID-19), the US government is providing advanced development support for a rapid diagnostic test and support for potential vaccines and treatments.
The US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) reports that it will provide advanced development support for a diagnostic test for coronavirus disease 2019 (COVID-19), which is designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours. The molecular diagnostic test from Hologic, a Marlborough, Massachusetts-based diagnostics and medical imaging products company, becomes the first COVID-19 product selected for development through ASPR’s Biomedical Advanced Research and Development Authority (BARDA) streamlined selection process, called an easy broad agency announcement (EZ-BAA).
BARDA will contribute $699,000 to accelerate Hologic’s development of a test that detects the genetic material of SARS-CoV-2, the virus that causes COVID-19. Test results could be available to clinicians in less than three hours, according to the HHS.
BARDA and Hologic expect that necessary developments will be completed in a matter of weeks, which then would allow the US Food and Drug Administration (FDA) to consider granting Emergency Use Authorization (EUA) for the diagnostic test. An EUA facilitates the availability and use of medical products needed during public health emergencies.
The test will be designed for use with the company’s Panther Fusion system. The system is available today in commercial laboratories in the United States and other parts of the world. The Panther Fusion system provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory infections, according to information from the HHS. “This existing infrastructure and supply chain would allow for rapid scale-up of the COVID-19 diagnostic test if the FDA issues an EUA, which would increase access to testing for more US patients and healthcare providers in the fight against COVID-19,” said the HHS in a March 9, 2020 statement.
There are currently no approved diagnostics, vaccines or treatments for COVID-19 infections, notes the HHS. However, the FDA issued emergency use authorizations of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, and for New York State’s Wadsworth diagnostics test. In addition, on February 29, 2020, the FDA also issued a new policy to help expedite the availability of diagnostics.
The HHS says it continues to work across the US government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect or protect against or treat COVID-19 for development and licensure. HHS divisions, including the National Institutes of Health and ASPR, have begun supporting development of multiple vaccines and treatments for COVID-19.
To obtain information about any potential products in development in the private sector that could be used in responding to the COVID-19 outbreak, the US government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.
To shorten the time to apply for product licensure and to reduce the spread of COVID-19, federal agencies are particularly interested in identifying products and technologies that have progressed beyond non-clinical studies, have established domestic large-scale commercial cGMP manufacturing capability, and have utilized a platform used to manufacture a product already approved by the FDA.
HHS announces CDC funding to state and local jurisdictions
Separately, the HHS has announced upcoming action by the US Centers for Disease Control and Prevention (CDC) to provide resources to state and local jurisdictions in support of the US response to the coronavirus (COVID-19).
Last week (March 6, 2020), President Donald Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The supplemental appropriations act contains $8.3 billion in funding government-wide, with resources directed for grants or cooperative agreements to states, localities, territories, and tribes to accelerate planning and operational readiness for COVID-19 preparedness and response, as well as develop tools and strategies, provide technical assistance and program support, as well as ensure ongoing communication and coordination among public health agencies and partners throughout the response.
On March 11, the HHS reported that the CDC is contacting State Health Officers to move forward with awarding over $560 million to states, localities, territories, and tribes. The CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding.