Small Labs Push Back Against VALID Ahead Of User Fee Markup: Inside Health Policy

• "Eric Konnick, assistant professor at University of Washington’s school of medicine, told Inside Health Policy that the VALID Act will stop academic labs from developing tests for rare diseases and cancers because diagnostics for rare diseases are often not profitable, and labs working on those tests will not have the resources to undergo the premarket requirements laid out in the bill"

• "Lee Bendekgey, chief policy officer at Invitae, said smaller labs likely will not be able to move quickly enough to get tests through FDA approval, as working with FDA is typically intense and time-consuming. The VALID premarket requirements could hurt the United States’ ability to respond to future public health emergencies, Bendekgey told IHP. The lab sector is critical for creating tests for new pathogens, and VALID could drive those same labs out of business."