In an industry first, bioanalytical CRO Tandem Labs has announced the availability of biomarker assays for human clinical studies using the Meso Scale Discovery V-PLEX biomarker platform, which have been already validated by Tandem in human serum.
Biomarkers can indicate the success or the failure of a therapeutic drug, and the more biomarkers companies can analyze using the same sample volume, the better their decision-making will be. The V-PLEX panels allow for simultaneous analysis of 10 biomarkers in the same assay well, which can help with blood collection regulation compliance and to cut central lab costs.
John Marcelletti, senior laboratory director at Tandem, explained to us that Meso “developed these assays and validated them with a fit-for-purpose protocol, but they didn’t use human serum to measure, but used buffers and the like to verify that the assays work. We’ve fully validated them in human serum so now a client who may just want to do a preliminary look at biomarkers can use ours and proceed with running their samples.”
“We’ve found a lot of clients want to study biomarkers on a limited budget so they’re reluctant to get involved with fully validating” them, Marcelletti added. Since their release, he noted that Tandem has had “a number of inquiries” and have since signed contracts.
The specific biomarker assays offered include:
• Proinflammatory: IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IFN-γ, & TNF-α
• Cytokine: IL-1α , IL-5, IL-7, IL-12/IL-23p40, IL-15, IL-17A, & GM-CSF
Marcelletti noted that Tandem“can do any combination of those.”
The proinflammatory and cytokine panels have already been validated in human serum. Other biomarkers in the V-PLEX platform, such as those in the chemokine panel, are scheduled for launch later this year.
Meso “launched their validated series as a 30-plex, and now increased to 40-plex,” Marcelletti said. “We’re still working on the chemokine panel and after some time we’ll get in touch with them with the more recently added biomarkers, which should launch very soon."
Meso validated their V-PLEX assays using fit-for-purpose methods and non-human matrix for controls. The scientific team at Tandem Labs adapted the V-PLEX platform to use human serum as a matrix for QC samples, which is more closely in line with regulatory guidance and industry standards, and which industry requested, Marcelletti said. Additional validation experiments in human serum were performed to verify accuracy and precision, selectivity, linearity and stability.
The validated assays and full results will be presented at the AAPS National Biotechnology Conference (NBC) this week in San Diego.
“The lack of validated tests for biomarkers has been a major limitation for important medical research, and our relationship with Tandem Labs provides the research community with greater access to high-performance multiplex immunoassays in a flexible and affordable format,” Jacob Wohlstadter, president and CEO of Meso, added.