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AMP Members Call For Better Future Pandemic Diagnostic Preparedness

By Allison Proffitt

November 3, 2021 | In a new article published in JAMA Health Forum last week, members of the Association for Molecular Pathology COVID Response Steering Committee offered recommendations to improve the US’s ability to respond to the current COVID-19 pandemic and prepare for future emerging infectious disease outbreaks.

The recommendations were born of member surveys AMP conducted in April and August 2020 of laboratories performing SARS-CoV-2 diagnostic testing in the US. “The April survey results included responses from over 100 laboratories, the majority of which were running full staffing, 7 days a week to perform SARS-CoV-2 testing, despite experiencing regulatory hurdles and supply-chain and staffing shortages,” the authors wrote, highlighting the pandemic burden that fell to its member labs.

But government overreach slowed those labs’ abilities to respond quickly to the spreading pandemic, the authors concluded, thus slowing the nation’s response. “Since the earliest days of the pandemic, it is clear that better coordination and integration are needed between clinical laboratories and the US federal government,” they wrote. “In the communities first affected, academic and clinical laboratories were not utilized in the critical early weeks when the virus spread undetected.”

They highlighted FDA’s initial requirement for labs to obtain emergency use authorization for COVID-19 laboratory developed tests (LDTs). LDTs have long been a source of contention between FDA and labs. The Department of Health and Human Services determined the FDA did not have the authority to regulate lab-developed tests for any condition—including COVID-19—in August of 2020.

But damage was done. The initial EUA requirement, “prevented many expert molecular diagnostic laboratories from rapidly offering high-quality, validated LDPs as is the norm outside of a declared emergency,” the AMP authors wrote.

Current, Future Recommendations

The COVID-19 pandemic is not behind us, the authors wrote—highlighting the new viral variants still emerging—and other viruses will likely emerge in the future. “Diagnostic testing continues to be a vital tool to identify infections, diagnose patients, and pinpoint and monitor outbreaks,” they said.

As such, they outlined three recommendations for the future.   

First, promote better collaboration and communication between public health and clinical laboratories and relevant government agencies in order to more effectively leverage capacities and capabilities to support testing needs. “CDC should strive to included additional qualified clinical laboratories in their Laboratory Response Network to enable rapid deployment of clinical diagnostic testing,” the authors wrote.

Second, maintain the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments (CLIA) program as the regulatory agency responsible for oversight of laboratory developed testing procedures, enabling clinical laboratories to rapidly develop and deploy high-quality diagnostic tests during a public health emergency. “To prepare for future pandemics, we must take advantage of the existing expertise and enable clinical laboratories to validate and offer robust clinical assays, rather than creating regulatory hurdles,” the authors wrote. They further recommended updating existing CLIA regulations to account for recent technological and medical advances.

Third, ensure clinical laboratories have a stable chain of supplies and infrastructure to respond optimally to pandemic needs, as well as other critical clinical testing, including for cancer, inherited conditions, and infectious diseases. Early in the pandemic most clinical labs deployed multiple SARS-CoV-2 testing methods as insurance against supply disruption. The authors acknowledged that this was highly unusual, but argued that it was necessary to ensure testing capacity. They suggest early and better use of the Defense Production Act or similar support from the federal government to ensure the supply chain is not disrupted.

“Diagnostic molecular testing is the keystone to an effective global response to this pandemic and any future infectious disease outbreaks,” they concluded, arguing for consensus now that will better prepare us for the future.

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