The American Society for Microbiology (ASM) commends the U.S. Food and Drug Administration (FDA) for implementing unprecedented policy changes to boost laboratory testing capacity and availability of SARS-CoV-2 tests. While there is still a lot of work ahead, the new policies announced on March 16, 2020, take important steps toward assisting clinical microbiologists and clinical labs around the country that are essential to the response to COVID-19.

ASM membership includes thousands of public health and clinical laboratory microbiologists who are on the front lines of testing for COVID-19.

ASM commends FDA for taking these steps:

• Allowing commercial manufacturers to distribute tests, and allowing clinical labs to use them prior to obtaining an emergency use authorization (EUA);
• Allowing certain states to approve laboratory-developed tests (LDTs) in high complexity CLIA labs; and
• Allowing serology testing to be conducted through a streamlined regulatory approach.

ASM has been actively engaged with Congress, the FDA and the White House Coronavirus Task Force on ways to address the challenges and barriers posed to these labs as the outbreak has unfolded. Specifically, ASM called for expanding testing by high complexity CLIA labs by removing certain regulatory impediments and called for a swift response to material shortages, including PCR reagents needed to validate tests, RNA extraction kits and swabs for collecting specimens. FDA’s announcement is an important step forward in addressing these issues, and ASM will continue to work with regulators to address additional concerns.

Clinical microbiology labs have been working around the clock to ensure that tests are safe, effective and are available at the point of patient care. By boosting lab capacity, millions of Americans will have greater access to testing at this critical juncture in the pandemic. We urge FDA to go further in advancing public health by removing additional barriers for high complexity CLIA labs to offer laboratory developed tests.

While the process for developing serological tests will take time, enabling this process is essential to identifying those who have been infected, but may have been asymptomatic. This may also help determine whether individuals who recover produce antibodies that then confer protection against reinfection. This is paramount to getting a handle on the potential trajectory of COVID-19.

ASM will continue to work with Congress, the White House Coronavirus Task Force and federal health agencies to ensure our nation’s response to the pandemic leads with science and public health and maintains open and timely communication with the American public and with our international partners.
  The American Society for Microbiology is one of the largest professional societies dedicated to the life sciences and is composed of 30,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.

ASM advances the microbial sciences through conferences, publications, certifications and educational opportunities. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.