AmericanBio, a premier provider of custom reagent manufacturing services, unveils their clinical laboratory solution “CLIA Grade” products. CLIA labs shared their needs and concerns with AmericanBio, which included inconsistent analytical results, poor functional performance results and ongoing regulatory pressures. Further, manufacturers of LDT’s, Molecular Diagnostic and Clinical Diagnostics needed a reliable contract manufacturing partner who is in tune with the CLIA market needs, requirements, and can credibly support their outsourcing strategies. AmericanBio in turn delivered a solution, developing its “Next Generation of Reproducible Reactions” with the CLIA Grade product line and CLIA Grade Custom Manufacturing Services.

As you know, the same reagents are sold to a wide range of industries, which are then utilized for varied customer types, and a multitude of other applications. Testing each reagent prior to use is a CLIA required action, and it can also be a costly and time consuming process if you don’t have confidence in the reagent and the supplier. Inconsistencies in reagents could have serious implications for your patients regarding their diagnosis and potential treatment.

AmericanBio understands the pains endured by manufacturers of Diagnostic and Molecular Diagnostic assays and reagents. Vincent Cooney, AmericanBio President sums it up quite simply, “we realize the need for a reliable and proven partner to provide them with the regulatory framework, validation needs, consistency, and quality driven metrics that will support their Diagnostic tool, that’s why we’re here, and that’s what we do best!”