Announcing The Validation Of Proinflammatory And Cytokine Multiplex Biomarker Assays For Human Clinical Studies Using The MSD® V-PLEX Platform

New service offers more flexible and cost-effective biomarker testing solution

You may be interested in a new service that increases the quality and breadth of biomarker analysis, while expediting sample analysis with a lower requirement for sample volumes -- all leading to better and faster decisions with less financial burden and risk.

Tandem Labs, one of the nation's largest bioanalytical CROs, has just announced the availability of validated multiplex biomarker assays for human clinical studies using the Meso Scale Discovery (MSD®) V-PLEX biomarker platform. This advance is an industry first that allows us to offer biomarker sample analyses for clinical studies on demand, helping you avoid the expense of independent method validation. The specific biomarker assays, which may be purchased together or in any combination, are in two multiplex panels:

• Proinflammatory: IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-2, IL-4, IL-6, IL-8, IFN-γ, and TNF-α
• Cytokine: IL-1α, IL-5, IL-7, IL-12/IL-23p40, IL-15, IL-17A, and GM-CSF.

Tandem Labs can analyze any combination of these analytes to provide clinical trial teams with the necessary information to support conclusions related to the drug pharmacodynamics and drug efficacy or toxicity end-points.

The proinflammatory and cytokine panels have already been validated in human serum and are available as such now. Other biomarkers in the V-PLEX platform, such as those in the chemokine panel, are scheduled for launch later in 2014.  All characterized assays are also available immediately in a fully qualified format for discovery and feasibility studies, allowing for substantial savings.

Less expensive screening, more rigor and confidence in analysis results
John Marcelletti, PhD, our San Diego immunoanalytical laboratory director, explains: "In speaking with clients, we identified a demand for a low cost, high quality biomarker analysis service. And it's being well received, because the cost savings allow drug development programs to move forward with less financial burden and risk. Overall, these biomarker analyses will allow clients to inexpensively screen many biomarkers with a highly characterized system to identify the most informative analytes for detailed study. At the same time, we know that clients will be well positioned for the rigor necessary for FDA submissions."

As you know, biomarkers are good indicators for the success or the failure of a therapeutic drug. These V-PLEX panels allow for simultaneous analysis of 10 biomarkers in the same assay well. Having 10 analytes analyzed with the same sample volume used to analyze one analyte can help in complying with blood collection regulations and also trims costs from a clinical central laboratory perspective.  Moreover, quite often biomarkers as single entities may exhibit modest clinical utility alone, but when combined as in a multiplex, the additive information can more accurately capture the complexity of a disease process yielding a powerful predictor for drug response potential.

"We are thrilled that Tandem Labs has validated our V-PLEX immunoassays" commented Jacob Wohlstadter, President and CEO of MSD.  "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."

MSD extensively validated the V-PLEX assays using fit-for-purpose methods and non-human matrix for controls. The Tandem Labs scientific team 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. Additional validation experiments in human serum were performed to verify accuracy and precision, selectivity, linearity and stability.

Click here for more information about MSD V-PLEX.

Want to learn more?
At our state-of-the-art immunoanalytical laboratories in San Diego, California, and West Trenton, New Jersey, we support biomarker work with scientific solutions that advance drug development programs using the most timely and cost-effective approaches.

If you're interested in learning more, please contact your business development representative or visit www.tandemlabs.com.