Medical Research Networx combines the resources and expertise of Bay State Biologicals and the Clinical Research Center of Cape Cod to provide a broad array of services in specimen acquisition, product development & manufacturing, clinical trials, and regulatory affairs to support the diagnostics, biotechnology, and pharmaceutical industries.  MRN enables the commercialization of novel products with consulting services, clinical trial design & management, and the acquisition of rare specimens and laboratory services. Whether new products are designed as Laboratory Developed Tests (LDTs), or for FDA submission, we offer comprehensive laboratory, clinical, and specimen support that aligns with the most aggressive project timelines.

MRN News

FDA Regulation of Laboratory Developed Tests

Laboratory Developed Tests (LDTs) include tests developed within a clinical laboratory, and offered directly to physicians through that laboratory.  Prior to 2004, these tests were of limited scope and typically offered to local or institutional physicians only. However, starting roughly ten years ago, LDTs have been offered more broadly by clinical laboratories, including commercial labs attached to medical device developers.  These now include companion diagnostics and molecular diagnostic assays, and available LDTs number in the thousands. 

Using Remnant Biospecimens In Medical Research

Remnant biospecimens:  What biospecimens are encompassed under the “remnant” umbrella, and what are the legal, moral and appropriate applications of remnant biospecimens?

MRN To Attend AACC 2014 Annual Meeting

MRN will be attending the AACC Annual Meeting in Chicago from July 27 - July 31, 2014.  The AACC meeting showcases the next generation of laboratory technology and fits perfectly with MRNs mission to be the largest and most respected provider of clinical and regulatory consulting services, biospecimens, and ancillary products to the biotechnology industry.  Hope to see you at our booth at AACC! 
© 2018 Medical Research Networx