Supply of an automated MALDI-TOF mass spectrometry system (Exent®) for the identification, isotyping and quantification of monoclonal immunoglobulins

This is a VEAT notice to indicate that the Mater Misericordiae University Hospital (MMUH) intends to utilise EU public procurement Directive 2014/24/EU, Article 32.2(b), negotiated procedure without prior publication, on the following grounds: (ii) competition is absent for technical reasons; and/or (iii) the protection of exclusive rights, including intellectual property rights. This notice is to indicate that MMUH intends to contract with The Binding Site Group Limited ("The Binding Site") for the supply of the Exent® system, an integrated automated platform based on matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF MS), for the identification, isotyping and quantification of monoclonal immunoglobulins in the diagnosis and monitoring of multiple myeloma and related plasma cell disorders. The justification for this decision is that The Binding Site is the sole manufacturer and supplier of a fully automated, integrated MALDI-TOF mass spectrometry platform validated for routine clinical use in the identification, isotyping and quantification of monoclonal immunoglobulins. No other economic operator manufactures or supplies an equivalent automated, integrated solution offering this combination of capabilities for routine clinical diagnostic use. The system and its associated reagents, consumables and software are proprietary to The Binding Site and are protected by intellectual property rights, and are not available from any other source. The equipment is required for the accurate and timely diagnosis, isotyping and monitoring of multiple myeloma and other monoclonal gammopathies, supporting improved patient outcomes through earlier detection and more sensitive monitoring of treatment response than conventional electrophoresis-based methods. The contracting authority has conducted a market review and is not aware of any other manufacturer offering a fully automated, integrated MALDI-TOF platform providing equivalent clinical functionality. The contracting authority therefore considers that no reasonable alternative or substitute exists and that competition is absent for technical reasons and by reason of the protection of exclusive rights, including intellectual property rights. The direct award is necessary to secure this clinically essential diagnostic capability.