QualTek Molecular Laboratories
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Companion Diagnostics
QualTek offers a logical and cost-effective option to companion diagnostic development. QualTek will first develop a quality assay and determine if the therapeutic and IHC test are effective - eliminating the mistake of prematurely investing in a commercial assay. QualTek then provides prospective testing of patient samples to generate pivotal information in conjunction with development of the most relevant companion diagnostic test.

Our philosophy for developing Companion Diagnostics is to serve as an advocate for our partners in all aspects of the process from assay development through commercial support. QualTek is not associated with a specific platform and we are unencumbered with no agenda other than supporting the success of our partners. We provide honest consultation throughout the process empowering our sponsors to make cutting-edge decisions for their therapeutic program.

Key services include:

    •  Prototype test development (e.g. PD-L1 assay for lung carcinoma clinical study)
    •  Platform independent approach
    •  Expert consultation for:
                                               Optimal antibody selection
                                               Appropriate scoring scheme
                                               Pivotal cut-off decisions 
                                               Strategy for testing & commercialization

    •  Prospective testing of clinical samples (CLIA)
    •  Accumulation of pivotal data 
    •  Validation reports for inclusion in regulatory filings
    •  Logical & cost-effective approach
QualTek is an experienced and trusted partner in developing IHC prototype assays for Companion Diagnostics.