ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
Changes in physician behavior around monitoring patient response to therapeutic monoclonal antibodies is increasing demand for clinical testing of these drugs.
Through connections with insurers, labs seek to give patients estimates of their financial responsibility for tests at point-of-sale or point-of-order.
Industry groups representing lab personnel strongly oppose CLIA's current practice of allowing personnel with nursing degrees to perform moderate- and high-complexity testing.
