Adam covers proteomics and the clinical lab market for GenomeWeb.
The platform allows users to run samples against an array of more than 1,800 autoantigens, with a focus on cancer, autoimmune diseases, and neurological conditions.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.
In a recent study, the 48-protein panel improved the diagnostic performance of existing Alzheimer's markers and helped predict progression of the disease.
FDA's recommendation that Alzheimer's patients be tested for APOE status prior to starting the drug could lead to new regulatory approvals and payor coverage.
Poor cross-compatibility may make it difficult to substitute components of automated sample processing and testing workflows in the case of shortages.
The South Korean firm recently launched a proteomics services product and signed its first US customer, the Salk Institute for Biological Studies.
The proteomics firm posted revenues of $29.4 million, up from $27.5 million in the year-ago period and below the consensus Wall Street estimate of $33.3 million.
The work points toward an approach for identifying modified and variant proteins that could aid the study of the proteoform content of biological samples.
The company said early customer feedback has led it to revamp instrument software, review R&D efforts, and put the launch of its sample prep module on hold.
The company's revenues climbed to $681.9 million from $588.4 million the year before, beating the consensus Wall Street estimate of $647.9 million.