ESA Bioscience benefits from CLIA waiver for rapid lead test, and FDA celebrates a "good moment"
This article was originally published in Clinica
At-risk children in the US can now be screened for exposure to lead at their school or at a local clinic with an easy-to-use test that gives results in three minutes. The FDA is expanding the availability of blood-lead testing by granting a so-called CLIA waiver to ESA Bioscience for its LeadCare II system. This increases the potential market for the test from the 35,000 hospitals, private labs and large physician practices currently deemed capable of performing moderate and high-complexity testing to more than 115,000 certified point-of-care settings.