The Observatory and Fast Facts

May 20, 2020

FDA revises policy on COVID-19 serology tests

The U.S. Food and Drug Administration (FDA) revised its policy on COVID-19 serology tests, and now requires commercial developers to apply for an emergency use authorization (EUA) for their tests.

Commercial developers have 10 business days from the date they notify the FDA that they have completed their validation testing on an antibody assay and are marketing the product. Under the original policy, posted March 16, the FDA allowed commercial developers to market their tests after completing internal validation studies.

As of May 4, The FDA said 12 antibody tests have been authorized under an individual EUA, while over 200 other antibody tests are the subject of a pre-EUA or EUA review.

Under the new policy, high-complexity laboratories that develop their own tests, called laboratory developed tests or LDTs, are not required to seek an EUA, although the FDA encourages them to do so. The labs must have a CLIA certificate, validate the tests, provide notice to the FDA about their intention to use the tests and follow the FDA’s labeling recommendations.

The serology tests detect immunoglobulin M (IgM) and immunoglobulin G (IgG)—the antibodies the body produces to fight off SARS-CoV-2, the virus that causes COVID-19 disease.

Anand Shah, MD, Deputy FDA Commissioner for Medical and Scientific Affairs, and Jeff Shuren, MD, Director of the FDA Center for Devices and Radiological Health, noted that some of the commercially available serology tests have “performed poorly” on evaluations conducted by the National Institutes of Health (NIH).

The FDA worked with the NIH, the Centers for Disease Controls and Prevention, and the Biomedical Advanced Research and Development Authority (BARDA) to develop the capability to validate the antibody tests at the National Cancer Institute (NCI). The idea is to use NCI data to guide FDA officials when they are evaluating EUA applications.

If tests perform poorly on the NCI evaluations, the FDA can ask test developers to submit additional information or it can stop the developers from marketing the tests in the United States, the agency said.

NIH mobilizes national innovation initiative for COVID-19 diagnostics

With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, the NIH said it will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability.

The NIH said it will work closely with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC) and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals.

The stimulus investment supercharges NIH’s research efforts already underway focused on prevention and treatment of COVID-19, including the recently announced planned Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership to coordinate the international research response to the pandemic.

As part of this initiative, the NIH said is urging all scientists and inventors with a rapid testing technology to compete in a national COVID-19 testing challenge for a share of up to $500 million over all phases of development.

The technologies will be put through a highly competitive, rapid three-phase selection process to identify the best candidates for at-home or point-of-care (POC) tests for COVID-19. Finalists will be matched with technical, business and manufacturing experts to increase the odds of success. If certain selected technologies are already relatively far along in development, they can be put on a separate track and be immediately advanced to the appropriate step in the commercialization process.

The goal is to make millions of accurate and easy-to-use tests per week available to all Americans by the end of summer 2020, and even more in time for the flu season.

While diagnostic testing has long been a mainstay of public health, newer technologies offer patient- and user-friendly designs, mobile-device integration, reduced cost and increased accessibility both at home and at the point of care. RADx will expand the Point-of-Care Technologies Research Network (POCTRN) established several years ago by NIBIB.

Led by the Coordinating Center at CIMIT, the network has assembled expert review boards covering scientific, clinical, regulatory and business domains that will rapidly evaluate technology proposals. Projects will be assessed at each milestone and must demonstrate significant progress to receive continued support.

NIAID strategic plan details COVID-19 research priorities 

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

The NIAID Strategic Plan for COVID-19 Research has four key priorities.

The first involves improving scientists’ fundamental knowledge of SARS-CoV-2 and COVID-19, including studies to characterize the virus and better understand how it causes infection and disease. This research includes transmission and surveillance studies to determine why some individuals experience mild symptoms of infection while others become critically ill. The role of asymptomatic individuals in viral spread and the potential seasonality of viral circulation also need to be explored, according to the report. In addition, the NIAID plans to develop small and large animal models that can recapitulate COVID-19 disease seen in humans.

NIAID’s second research priority is the development of rapid, accurate diagnostics and assays to identify and isolate COVID-19 cases and track the spread of the virus. Molecular assays can detect low levels of SARS-CoV-2 and differentiate it from other related viruses. Researchers will work to improve the speed and accuracy of these diagnostic assays to mitigate the spread of the disease during the current outbreak and any future ones. NIAID also said that new and improved serologic assays to detect antibodies to the virus must be developed to enhance surveillance efforts and identify individuals who may have resolved a previous COVID-19 infection.

The third research priority is characterizing and testing potential treatments for COVID-19. These efforts will include identifying and evaluating drugs already approved for other conditions that could be repurposed to treat COVID-19 and testing novel broad-spectrum antivirals, such as remdesivir; virus-targeted antibody-based therapies; monoclonal antibodies; and host-directed strategies to target an individual’s immune response to the virus. To optimize findings during the pandemic, multiple clinical trials will be conducted in parallel among various patient populations, including hospitalized people and outpatients.

NIAID’s fourth research priority is to develop safe and effective vaccines to protect individuals from infection and prevent future SARS-CoV-2 outbreaks. NIAID researchers and their collaborators are adapting vaccine candidates and approaches previously employed to address the related Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses and apply them to the current pandemic. For example, NIAID recently launched a Phase 1 clinical trial using a vaccine platform initially developed to target MERS. NIAID will use its broad clinical trial infrastructure to advance experimental vaccines through Phase 1 safety and dosing testing and simultaneously plan for advanced clinical testing of the most promising candidates. The institute will work with government partners to ensure that any safe and effective vaccine will be manufactured in sufficient quantities to allow expedient distribution to those at highest risk for infection.

To achieve its four priorities, NIAID will build on its current resources, research programs, clinical trials networks and collaborations with other U.S. government agencies and other key U.S. and global partners. The new strategic plan aligns with priorities set by the White House Coronavirus Task Force and represents a comprehensive and coordinated effort to develop effective biomedical tools to combat COVID-19.

CDC launches national viral genomics consortium to map SARS-CoV-2 transmission

The Centers for Disease Control and Prevention (CDC) has kicked off the SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES) consortium, which will greatly expand the use of whole genome sequencing (WGS) of the COVID-19 virus.

This national network of sequencing laboratories will speed the release of SARS-CoV-2 sequence data into the public domain.

SPHERES will provide consistent, real-time sequence data to the public health response teams investigating cases and clusters of COVID-19 across the country.

Genomic sequence data can provide insight into the biology of SARS-CoV-2, the virus that causes COVID-19, and help define the changing landscape of the pandemic. By sequencing viruses from across the United States, CDC and other public health authorities can monitor important changes in the virus and use this information to guide contact tracing, public health mitigation efforts, and infection control strategies.

The SPHERES consortium will coordinate SARS-CoV-2 genome sequencing nationally, organizing dozens of smaller, individual efforts into a single, distributed network of 40 state and local public health departments, several large clinical laboratories, and over two dozen collaborating institutions across the federal government, academia, and the private sector.

Consortium members share a commitment to rapid open sequence sharing. They plan to submit all useful sequence data into public repositories at the National Library of Medicine’s National Center for Biotechnology Information (NLM/NCBI), the Global Initiative on Sharing Avian Influenza Data (GISAID), and other public sequence repositories. This will help ensure that that viral sequence data from across the United States is rapidly available for public health decision making and freely accessible to researchers everywhere.

NIH-supported research survey to examine impact of COVID-19 on rare disease community

For the millions of people living with a rare disease, COVID-19 presents challenges, from potential reduced access to needed medical care to possible heightened anxiety and stress. A new online survey launched by the National Institutes of Health-supported Rare Diseases Clinical Research Network (RDCRN) aims to find out how the COVID-19 pandemic is impacting individuals with rare diseases, their families and their caregivers.

Results will help the rare disease research community shed light on the needs of people with rare diseases during the COVID-19 pandemic and other potential health crises, in addition to informing future research efforts.

The RDCRN, led by NIH’s National Center for Advancing Translational Sciences (NCATS), in collaboration with nine other NIH institutes and centers, is made up of 20 recently funded clinical research consortia focused on better understanding how rare diseases progress and developing improved approaches for diagnosis and treatment. Scientists from different disciplines at hundreds of clinical sites around the world work together with about 140 patient advocacy groups to study more than 200 rare diseases, including immune system disorders; heart, lung, and kidney disorders; brain development diseases and more.

Though individually rare, affecting only a few hundred to several thousand people, rare diseases collectively affect an estimated 30 million people in the United States. Many rare diseases are life-threatening, and about half of those affected are children.

The research survey is one of the first efforts nationwide to quantify the impact of a health crisis on the rare disease community