Supporting the Development of Diagnostic Pipelines
After qualification of the potential utility of a biomarker signature, multiple routes of application and implementation are possible. Selecting a regulatory strategy early in the development of biomarkers into diagnostic assays is extremely important to maximize the chances of regulatory approval (if required) and widespread clinical acceptance.
As a CLIA-certified laboratory with proficiency in all stages of the diagnostics development process, MD Biosciences can perform services such as internal assay verifications and CLIA assay transfers for implementation at our facility as a laboratory developed test (LDT). Additionally, such LDTs can be further developed into through our products division for submission to the FDA as an in vitro diagnostic device (IVD) or a companion diagnostic (CDx) for use in the selection of patients likely to benefit from targeted therapies.
Whatever the regulatory framework our clients may be hoping to explore for development of their diagnostic products, they can be sure that MD Biosciences has the experience and expertise to position their program for success.
Clinical Diagnostic Services