The findings suggest that guidelines for chronic kidney disease testing, which have come under increased scrutiny in recent years, could benefit from including albumin and cystatin C levels in definitions of the disease.
Genentech is proposing to conduct a randomized, controlled confirmatory trial that "would include a biomarker component to identify patients who may be more likely to derive a more substantial benefit from Avastin." Such a strategy would align with FDA's personalized medicine focus, the company points out.
Attention to assay reproducibility and selection of appropriate intended use populations will be key to the success of proteomics-based tests, FDA staff fellow Joshua Levin suggested at a talk this week discussing the agency's review of two mock submissions for protein IVDMIAs.
According to the patent, the company identified the proteins serum amyloid A and S-sulfonated transthyretin as biomarkers for myocardial infarction and developed a three-marker panel consisting of SAA, SS-TTR, and known MI biomarker myoglobin.
With diagnostic development shifting from single-marker to multi-marker tests, multiple-reaction monitoring mass spectrometry has emerged as a potentially valuable clinical tool. Further improvements in the platform's cost and variability are needed, however, to make it competitive with immunoassays.
The collaboration aims to turn IBI's mass-spec immunoassay technology from a tool it has offered exclusively on a contract-research basis into a turnkey product available to clinical research laboratories around the world.