A joint venture between FDA, the Centers for Disease Control and Prevention (CDC) and several non-government stakeholders is designed to address concerns in public health laboratory testing capacity within the three major agencies. The participants signed a Memorandum of Understanding (MOU) that will enhance laboratory testing surge capacity outside of CDC and public health laboratories both before and during public health emergencies.
In making the announcement, FDA said that partnerships and engagement between the public and private sector were crucial to support significant increases in demand for diagnostic testing during any public health emergency—a scenario that came to light during the COVID-19 pandemic.
Any emerging pathogen that spreads quickly and/or has the potential to cause significant disease in humans will lead to demands for a higher volume of laboratory diagnostic testing that likely exceeds the current testing capacity, the MOU noted. “Public health laboratories (PHLs) have expertise characterizing infectious organisms, handling clinical and non-clinical samples, and many have the ability to scale up routine operations to provide surge capacity during a response,” the statement noted.
It’s not uncommon for PHLs to assist during times of crisis, as they did for the Anthrax scare of 2001, the response to the Middle East Respiratory Syndrome, and recent Ebola outbreaks. Still, these laboratory systems are not currently designed to handle and execute diagnostic testing at a large scale and scope beyond the initial critical phases of public health emergencies. “Based on these experiences, partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic,” the MOU stated.
Since food is always a top priority in laboratory testing, it will be a vital component of the MOU. “If we can ensure the safety of our staff and ensure accurate, legally defensible data, [we] will always be willing to help support public health and safety in any way we can,” Derrick Tanner, general manager of Portland, Ore.-based Columbia Laboratories, tells Food Quality & Safety.
Emily Volk, president of the College of American Pathologists, notes that the MOU is important in discovering new solutions for testing as well. “Pathologists have been on the front line of the COVID-19 crisis, responsible for developing and selecting new test methodologies, validating and approving testing for patient use, and expanding the testing capabilities of the communities they serve to meet urgent and evolving needs,” she says.
Going forward, CDC will collaborate with the MOU partners to enhance existing relationships with other government agencies and stakeholders in the laboratory community to support external laboratory surge testing capacity for any emerging public health threats.