Adam covers proteomics and life science mass spectrometry for GenomeWeb.
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 UK company plans to launch a CE-IVD version of the test in 2021 and anticipates launch of an FDA-cleared test shortly thereafter.
With two FDA-cleared platforms available, the technology is drawing clinicians interested in reaping its near-term benefits while preparing for its future impact.
According to the company, it has shipped more than 1,700 of the IVD analyzer platforms since launching sales globally in 2017.
Nursing home lab testing, traditionally a low margin and labor intensive business, has been particularly impacted by PAMA-driven reimbursement cuts.
The guidelines provide recommendations for what CYP2C9 variant alleles should be included in clinical pharmacogenomic tests assessing that gene.
A Roche executive said he expects essentially all the firm's US troponin customers will convert to the high-sensitivity assay over the next two to three years.
A decades-long decline in medical technician training programs and large numbers of looming retirements have labs scrambling to fill their vacancies.
The facility will be mass spec-focused and comprise a service contract lab for developing protein tests and a CAP- and CLIA-certified lab for offering them.