The U.S. FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic Systems Inc. DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. The Medford, N.Y.-based company’s antibody test was one of the first authorized by the FDA during the COVID-19 public health emergency. At the time of authorization, the agency concluded that the test met the statute's "may be effective" standard for EUA, and that the test's known and potential benefits outweighed its known and potential risks. Data submitted by the company, coupled with an independent evaluation of the test at the National Cancer Institute, showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device.
Separately, the agency outlined the steps for a test to be authorized for broad screening of asymptomatic individuals by publicly providing information in updated templates for developers on the FDA’s expectations. In addition to these template updates, the FDA has made available FAQs with information regarding tests for screening asymptomatic individuals.
The FDA also issued a final guidance Wednesday advising on statistical considerations for proposed changes to the conduct of clinical trials due to COVID-19 that may impact the analysis and interpretation of a trial’s primary or key secondary endpoints. “Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments,” the agency said. The guidance is intended to help ensure that trials conducted during the pandemic will provide interpretable findings with correct statistical quantification of uncertainty.
House Energy and Commerce Chairman Frank Pallone (D-N.J.) said the full committee will hold a hearing June 23 – titled “Oversight of the Trump Administration’s Response to the COVID-19 Pandemic” – on the nation’s COVID-19 response. Confirmed witnesses thus far are Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases within NIH, Brett Giroir, assistant secretary for health, FDA Commissioner Stephen Hahn and CDC Director Robert Redfield.
The NIH plans to invest $25 million over five years in the new Accelerating Leading-edge Science in ALS (ALS2) program. Part of the NIH Common Fund’s High-Risk, High-Reward research program, ALS2 is intended to spur innovative research on amyotrophic lateral sclerosis (ALS). Focused investment in research from a range of scientific disciplines is needed to capitalize on genetic research that recently has provided clues to understanding the disease, according to the NIH. ALS2 will follow a three-pronged approach: adapting emerging tools and technologies from neuroscience and cell biology to identify what causes ALS at the molecular level and how the disease progresses; attracting new talent from a range of scientific disciplines, and examining biological similarities between ALS and motor neuron disease in other neurodegenerative disorders.