WASHINGTON, D.C. — Following the introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2020, ACLA President Julie Khani issued the following statement:
“ACLA and our member companies are focused on responding to the growing demand for COVID-19 testing capacity. In the coming days, ACLA will be reviewing the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 with our members and engaging with stakeholders on the Hill and the broader health care community.
Over the past several years, ACLA and our members have been actively working with stakeholders to advance meaningful comprehensive diagnostic reform for patients. As we’ve consistently stated, a modernized regulatory framework must ensure sustained innovation for patients and providers and support continued access to the laboratory tools necessary for the diagnosis, monitoring and treatment of disease.
Specifically, ACLA has consistently pushed for three main priorities: 1) reform that recognizes diagnostics as separate and distinct services from medical devices as well as distinctions between LDTs and IVDs; 2) grandfather and transition policies that protect patient access to currently available laboratory tests; and 3) a regulatory system that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.
We’re grateful for Representatives Diana DeGette (D-CO) and Larry Bucshon (R-IN) as well as Senators Michael Bennet (D-CO) and Richard Burr (R-NC) for their leadership and attention to this critical issue.”
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.