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. 

MRN Signs Sales Agency Agreement With Zeptometrix Corporation

Medical Research Networx, LLC (MRN) today signed a Sales Agency Agreement with Zeptometrix Corporation (ZMC). Under the terms of the agreement MRN will act as ZMC Sales and Marketing Agent with its existing IVD Clients coordinating the Sales process on behalf of Zeptometrix. In addition MRN will communicate new products and services with all existing and potential IVD Clients worldwide.

MRN Launches PreDict Product Development Service Offering

Medical Research Networx, LLC launches PreDict Product Development Service offering. MRN will now offer scalable services ranging from the design and development of assays to commercially-ready laboratory developed tests (LDT) or FDA cleared kits under a complete Quality System. Through MRN’s commercial partners, MRN can offer FDA-audited cGMP facilities for contract manufacturing. MRN’s preferred clinical sites are CLIA/NYS accredited labs within leading university centers, within globally recognized centers of excellence.

MRN Announces Distribution Agreement Between MRN and Biomex GMBH

Medical Research Networx, LLC (MRN) announced today a Distribution Agreement between MRN and Biomex GMBH of Heidelberg, Germany, making MRN the exclusive distributor of Biomex products in the United States.  Biomex is a worldwide provider of human plasma for further manufacture of IVD products, offering high volume plasma from patients with infectious diseases such as plasma containing high titers of IgM antibodies to toxoplasma, rubella, cytomegalovirus and herpes simplex virus (ToRCH Panel).  Biomex also provides high volume plasma with high antibody titers to HIV g O, HIV 2, Hepatitis B

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