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SARS-CoV-2 Experience Will Help Agency Strike Right Balance With LDTs, FDA Says

WASHINGTON — At the American Clinical Laboratory Association's 2020 Annual Meeting Wednesday, representatives from the US Food and Drug Administration made the case that the agency's response to the SARS-CoV-2 outbreak may be instructive for the future oversight of laboratory-developed tests. 

At the meeting, FDA Commissioner Stephen Hahn addressed the agency's efforts to expand access to testing for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and its actions on LDT oversight. "We will learn from the COVID-19 outbreak many of the things we need to do moving forward to provide that regulatory balance and do the right thing for the American people," said Hahn. 
He added that the FDA is committed to the legislative process regarding LDTs and emphasized the importance of using data, empowering consumer choice, and increasing competition through innovation.
"We need to make sure that our tests are accurate, reliable, and clinically meaningful," Hahn said. "We are in this together and the American people depend on us." 
At the meeting, the agency's response to the current coronavirus crisis was understandably a major point of interest among lab industry attendees. COVID-19 has been an increasing problem in the US, with multiple media sources reporting 149 cases across the country and 11 deaths. But there have been hiccups along the way in how the government has handled the crisis, namely access to the Centers for Disease Control and Prevention's emergency-use-authorized tests had a delayed rollout to labs due to issues with a reagent. 
On Saturday, the FDA attempted to expand testing capacity via a new guidance allowing high-complexity labs to start immediately using tests they had validated without having to wait for emergency use authorization from the FDA. Hahn emphasized at the meeting that the EUA standard hasn't changed, but under the new guidance, labs can run their LDTs as long as they submit an EUA within 15 days of testing. The data submission can be done via email, Hahn said. According to one estimate, between 300 and 400 labs in the US have the capability to perform such testing, though not all may decide to provide it under EUA. 
In a later panel discussion, Elizabeth Hillebrenner, chief of staff and associate director for scientific and regulatory programs at FDA's Center for Device and Radiological Health, said the agency is asking labs to send their first five positive and negative tests for SARS-CoV-2 to the CDC for one of its public health labs to verify the results with an EUA-certified test. 
Hillebrenner added that the agency is looking at the submitted data on a rolling basis, so labs can send their validation data to the FDA piecemeal as they receive it, to speed the process up. 
The commissioner, meanwhile, said the agency has heard from four labs adhering to the new guidance, and was expecting to hear from a fifth lab on Wednesday.
So far, the FDA has granted EUAs to only two tests, one from the CDC and one from New York state. According to Hahn, both requests were reviewed and authorized in 24 hours. 
The CDC is also increasing the number of tests distributed under its EUA by contract manufacturer Integrated DNA Technologies. Hahn said IDT aims to manufacture 2,500 test kits, and perform 500 tests per kit by the end of this week. 
Hahn emphasized that the COVID-19 emergency shines a light on how important LDTs are to healthcare and the "critical role they can play in daily, nonemergency situations as well." He added that the agency wants to keep demonstrating regulatory flexibility, especially in public health emergencies, but also doubled down on the need for more oversight when the public health is at risk. 
Hahn said that while the vast majority of lab tests are performed according to sound science, he specifically called out certain labs for making pharmacogenetic test claims that are unsupported by evidence. He said the FDA knew of labs marketing tests that claimed patients needed higher doses of opioids. "We've seen clear situations where even the developer acknowledged they did not have evidence to support the claims they were making," he said. 
The flexibility the FDA is demonstrating during the COVID-19 emergency, however, may end up serving as a model for balancing access and patient safety as the agency considers broader test oversight with legislators, Hillebrenner suggested. Legislators have advanced a draft bill, called the VALID Act, which seeks to advance a new regulatory framework for all diagnostics, including LDTs. The FDA has provided extensive feedback to legislators on this bill, which according to some industry insiders may be introduced soon. 
After the emergency passes, Hillebrenner said that stakeholders should reflect on the actions taken during the crisis and consider the lessons learned in the context of the overarching framework and EUA provisions in VALID. "We're committed to the legislative process and we're committed to working with all of you at the direction of Congress to have those conversations," she said. "We are open minded. We want to learn from this experience and apply it as best we can going forward." 
In a statement Wednesday after meeting with Vice President Mike Pence and the FDA, ACLA said its members still aren't "collecting, processing, or transporting specimens for [SARS-CoV-2] testing from patients suspected of having, or confirmed to have" the coronavirus. ACLA is also requesting clarity around guidelines on screening high-risk patients, recommendations on transporting and handling specimens, and test validation requirements, as well as increased federal funding to expand testing capacity. 
Julie Khani, president of the ACLA, said the organization's members are working to develop novel tests for SARS-CoV-2, along with supporting other ways to bolster testing capacity. "As Congress works on needed funding for our national response, clinical labs are working around the clock to ensure that patients will have access to important clinical diagnostics," Khani said.