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 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.
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 firms said that Bio-Techne's Ella platform provides the sensitivity needed to provide analysis of the Nf-L biomarker for neurodegenerative diseases.
Cyclomics, a 2018 spinout from University Medical Center Utrecht, is testing its assay for treatment response and recurrence monitoring in head and neck cancer.
The lab beat the consensus Wall Street estimate on the top and bottom line, and maintained its revenue and adjusted EPS guidance for full-year 2019.