The Dublin, Ireland-based company plans to launch its new instrument by the end of 2021 and will pursue CLIA waiver in the US.
The ARUP COO recently published a commentary providing the clinical lab perspective on recent congressional proposals around LDT regulation.
Though the designation has seen slow uptake thus far, three tests received ADLT status in May, bringing the total number of approved ADLTs to five.
The researchers have developed CompCyst, which uses clinical features, imaging, and molecular data, to guide pancreatic cysts treatment approaches.
The UCSF spinout aims to develop noninvasive tests to detect kidney injury for the transplantation field and to diagnose and monitor chronic disease.
Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.
The company decided to settle the complaint in order to avoid "lengthy and distracting litigation," but denies any wrongdoing.
The letter supporting the LAB Act, which would delay reporting of lab payment data under PAMA, was submitted to the House Energy & Commerce Committee.