AACC endorsed the Verified Innovative Testing in American Laboratories (VITAL) Act, which would clarify the law around laboratory-develop tests (LDT) and definitively locate LDTs oversight solely within CLIA administered by the Centers for Medicare and Medicaid Services (CMS). This effort pushes back against other moves from Congress and the Food and Drug Administration (FDA) to move LDTs further under FDA’s purview, creating a cumbersome and duplicative regulatory structure.
In a letter to the VITAL Act’s sponsor, Senator Rand Paul, R-Ky., AACC wrote that it agrees “that the increase in the number and complexity of LDTs may warrant a fresh assessment of the regulatory and professional oversight for these tests.” However, while “some adjustments may be necessary,” the association believes CLIA oversight is sufficient.
“The FDA regulatory structure is designed for medical device manufacturers, not clinical laboratories. Laboratories occasionally modify FDA-cleared or approved tests or develop new in-house tests to meet specific clinical needs,” AACC wrote. “To add FDA requirements to clinical laboratories utilizing these tests will stifle innovation and hinder patient access to testing, as occurred recently when the FDA became involved in LDT oversight during the outset of the COVID-19 public health emergency.” The VITAL Act would prevent such delays in developing needed tests in the future, the association added.
AACC Urges Coronavirus Taskforce to Bolster Lab Access to Testing Supplies
In a letter to the administration’s Coronavirus Task Force, AACC called on the White House to tackle the critical needs clinical laboratories face around sample collection, analytical test components, and personal protective equipment.
New guidelines released by the White House call for an extensive testing scheme that states are expected to rely on to reopen their economies.
Guidelines recommend that states first ensure they have the ability to quickly set up safe and efficient screening and testing sites for individuals with symptoms of COVID-19, the illness caused by SARS-CoV-2. These guidelines also recommend that states test syndromic and influenza-like illness-indicated persons for COVID-19, ensure sentinel surveillance sites are screening for asymptomatic cases, and trace contacts for all SARS-CoV-2 positive results.
“AACC’s members, as laboratory professionals, are on the front lines combating this disease,” AACC wrote in the letter. “While the capacity for performing COVID-19 testing has increased significantly in recent weeks, our ability to perform tests is still limited. There is a shortage of necessary supplies, including sample collection and test components ... Unless and until these supply chain issues are resolved, the nation’s laboratories will remain stymied in their attempts to maximize their testing capacity. At this point, the biggest barrier to testing is not capacity, but access to vital supplies.”
The letter encourages the Coronavirus Task Force to communicate “directly and regularly” with the clinical laboratory community to address barriers to testing.
Pharmacists May Administer COVID-19 Testing
The Department of Health and Human Services (HHS) issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to “order and admin-ister” SARS-CoV-2 testing that has been authored by the Food and Drug Administration (FDA). The guidance specifically notes that this can include serology tests.
According to the HHS guidance, pharmacists are “well positioned to aid COVID-19 testing expan-sion.” The guidance also notes that the majority of Americans live close to a retail or independent community-based pharmacy.
Some pharmacies maintain a CLIA certificate of waiver that allows them to perform certain tests termed CLIA waived. In the case of the novel coronavirus, FDA has said that any test with an emergency use authorization (EUA) in-dicating it is appropriate for point-of-care use should be considered CLIA waived. At CLN press time, these waived EUAs included the Abbott ID NOW, Mesa Biotech Accula, and Cepheid Xpert Xpress.