BARDA strategic covid plan 2022-202626 May 2022 16:13
BARDA COVID-19 Diagnostic Investments
Diagnostics are a crucial tool to aid in the diagnosis and inform management and treatment of COVID-19 patients, which can assist in reducing the spread of this deadly disease. BARDA supported multiple as- says for SARS-CoV-2 infection that spanned over 40 diagnostic products. From May to June 2020, ap- proximately 40% of the COVID-19 diagnostics available for Americans were the result of BARDA invest- ments. These included high-throughput devices in commercial clinical labs and hospitals, point-of-care tests for use in provider offices and limited testing resource settings (such as nursing homes), and over- the-counter tests for home use. Tests supported also included multiplex molecular diagnostic tests that detect SARS-CoV-2, in addition to influenza A and B viruses, and, in some cases, respiratory syncytial virus (RSV). BARDA’s first supported diagnostic was authorized for emergency use in March 2020. BAR- DA also supported the development of diagnostics to distinguish specific SARS-CoV-2 variants when needed to inform therapeutic usage. BARDA also collaborated with NIH, providing both financial support and subject-matter expertise to facilitate rapid launch of the RAD-X program.
In parallel, BARDA invested in rapidly deployable capabilities that augment current diagnostic technol- ogies, leveraging the physiological, host biomarkers, and vital sign data from patients. These included exploring the capability of non-invasive, wearable physiological sensors, remote monitors, and telemedi- cine tools to empower individuals and health care providers to better inform on infection status (including those that may be asymptomatic or pre-symptomatic) or infection severity. Such technologies could aid in identifying at-risk individuals, reducing further transmission by providing early indication of infection and monitoring mildly ill patients that may be progressing to more severe illness.
In addition, BARDA supported technologies that included electronic health records – integrated algo- rithms, apps, and blood biomarker-based in vitro diagnostics. These efforts empowered health care pro-
viders in the emergency department and hospital. Such technologies could provide early information on health deterioration to aid health care providers in management of patients to improve patient outcomes and allocate resources.
BARDA also partnered with DoD to make substantial investments in domestic diagnostics manufactur- ing, which will increase diagnostic test production capacity output from 18 million to 72 million tests per month in 2022 and will help ensure domestic supply.
BARDA’s COVID-19 response continues with new countermeasures in development, and BARDA antici- pates incorporating current and future activities to address SARS CoV-2 as a durable facet of its mission. In addition, there is an opportunity to expand indications beyond COVID-19 .