CLOSING THE WINDOW OF TIME BETWEEN INFECTION AND DETECTION

Reducing the time to detect infectious diseases and cancers is the main focus of the diagnostics industry. The earlier a test can be detected, the more favorable the outcome for the patient because they can be treated before the disease progresses beyond help.

MRN Diagnostics can help you design and validate your cutting-edge diagnostic.

DIAGNOSTIC
DESIGN AND DEVELOPMENT

MRNDx partners globally with diagnostic developers and manufacturers to optimize and validate the performance of their tests. MRN supports the development of: rapid point-of-care, serology, antigen and molecular testing platforms. By providing

precise clinical specimens and certified analytical service testing, MRN is able to accelerate your development pipeline. To complement this MRN also provides OEM kit control design, development, validation and GMP and ISO 13485:2016 compliant manufacturing. All of MRN liquid and swab controls are ready to use, noninfectious with room temp or refrigerated stability for antibody, antigen and molecular testing platforms.

DIAGNOSTIC DEVELOPMENT
PRODUCT PIPELINE

PRODUCT FEASIBILITY

DEFINING PERFORMANCE SPECIFICATIONS AND MANUFACTURING REQUIREMENTS FOR YOUR DIAGNOSTIC PRODUCT

At MRN Diagnostics, we work with your development team to determine the feasibility of producing your diagnostic product. This is the first step in our Design, Development and Manufcturing Product Pipeline. We begin by examining the requirements for developing, validating and manfacuring your product for commercial sucess. This assessment examines your companies capabilities prior to development work to guarantee that your product is designed and manufactured manufactured within the capabilities of your organization while also meeting the needs of the commercial marketplace.

EVALUATING CLINICAL ASSAY PERFORMANCE IN A CLINICAL SETTING

MRN Diagnostics performs prospective collections to obtain the optimal biological specimens to challenge the indications of use of your diagnostic test. To obtain these materials our Clinical Collectons Group develops protocols, IRB and Informed Consent documentation, and trains and audits our sites globally for specific collections. MRN is always preparred to go and collect biospecimens in the global region where the outbreak occurred.

Shown above is a map of our worldwide collection sites where we run our prospective collections for your product.

VERIFYING THE PERFORMANCE OF YOUR TEST AGAINST PRODUCT SPECIFICATIONS

MRN Diagnostics Analytics Division (GCP and ISO13485:2016 compliant), performs validation testing for your product utilizing multiple testing platforms which include: molecular, antigen and antibody testing. We use your test and this instrumentation to verify and validate the input and output claims of your design process