AACC’s data from December 2020 to January 2021 show that 60% of responding laboratories continue to encounter problems obtaining supplies needed to perform SARS-CoV-2 testing. In fact, the percentage of laboratories able to procure sufficient test kits has worsened over the past few months. In May 2020, 48% of responding laboratories said they were unable to obtain test kits. This figure now stands at 58%, with 50% reporting trouble obtaining reagents.
Importantly, the supply problem is undermining other types of diagnostic testing, too. Now 58% of laboratories say they cannot perform all their non-COVID-19 related tests due to supply shortages. AACC is calling on Congress to work with federal agencies and the healthcare community to develop a clear, transparent plan for ensuring that officials at the national level are aware of essential laboratory supply needs and a distribution process is put in place to more efficiently produce and allocate supplies.
Meanwhile, federal help might be on the way from the executive branch, but as yet, there are few specifics. President Biden issued an executive order in January directing the heads of government agencies to work with the administration’s COVID-19 Response Coordinator and use the defense production act to close gaps for testing materials. That 1950 law allows the president to force private companies to prioritize orders from the federal government.
Defense, Health Departments Pay Up for Home SARS-CoV-2 Tests
The Department of Defense, in coordination with the Department of Health and Human Services, announced a $231.8 million agreement with Australian diagnostic test company Ellume to onshore production capacity of its COVID-19 Home Test. The test is the first rapid self-test for SARS-CoV-2 detection authorized by the Food and Drug Administration for both asymptomatic and symptomatic use without a prescription. The test can be performed in about 15 minutes from a nasal swab specimen with results reported on a dedicated smartphone app.
Under the agreement, Ellume’s U.S.-based manufacturing facility will deliver 8.5 million home tests. The expansion is also expected to allow the company to keep producing even more units. Once at full capacity, the U.S. facility will be able to produce up to 19 million tests per month. Development of Ellume’s COVID-19 Home Test was supported by the National Institutes of Health Rapid Acceleration of Diagnostics initiative program.
Biden Administration So Far Silent on LDT Regulation
Department of Health and Human Services officials in the previous administration surprised the lab community in 2020 by officially stating that the Food and Drug Administration (FDA) did not have authority to regulate laboratory-developed tests (LDT) without formal rulemaking. At the time, even officials within FDA made the case that the agency should be able to oversee LDTs.
Now some observers, including FDA’s former acting chief scientist Luciana Borio, MD, are calling on the Biden administration to reverse course. Boria made the case in testimony before a House Energy and Commerce health subcommittee hearing on February 3. “There is tremendous confusion about the approach FDA is taking to facilitate access to appropriate tests, while ensuring that tests perform to a minimal standard,” Boria said. “The last administration hurt the American public when it declared that FDA did not have the authority to regulate laboratory-developed tests.”
So far Congress’s efforts to deal with LDT oversight have failed. Sen. Rand Paul (R-Ky.) introduced in 2020 the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify federal oversight of LDTs under CLIA. AACC has endorsed the VITAL Act and has long held that LDTs are already regulated under CLIA and do not need an additional layer of oversight from FDA.