Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
Becton Dickinson's HPV assay was FDA-approved for use with clinician-collected samples in 2018 and received approval for sample self-collection in May.
NEW YORK – Natera announced on Wednesday that its Prospera Lung test has received coverage from the US Centers for Medicare and Medicaid Services for single lung transplant patients in the ...
The company analyzes urine samples using a lateral flow test and optical reader combined with artificial intelligence to predict lung disease exacerbations.