Best Practices and Pitfalls in Commercializing IVD-Applicable Biomarkers

Before biomarker discoveries can be commercially utilized in clinical laboratories, many studies and surveys need to be completed and many questions answered. Is there a market need? Is there enough scientific and clinical evidence to convince the end users? Is the biomarker patentable? Is the translation into a practical product feasible? Although commercial product development is not the focus of academic research, the route to reach the patients will almost always require a professional commercialization process. Understanding industry and end-user requirements is essential for the successful commercialization of new biomarker assays. The current handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery, development, patent protection and technology transfer at universities, hospitals and research organizations. The focus is on in vitro diagnostics (IVD)-applicable biomarkers, i.e. markers intended to provide information on the health status of a person. The input for the collection has been sought from true-life practices: practices found in literature or taught by experts in the field; opinions and expertise of different stakeholders (end users, companies, technology transfer professionals, researchers, financiers); recommendations, regulation and laws; as well as practices learned the hard way, i.e. repeatedly failing somewhere in the process and later adapting the process for increased success. The main target group of the handbook comprises professionals working in Technology Transfer Offices (TTOs). The presented practices are yet not intended to be interpreted as strict rules but rather as a source of inspiration. Optimal ways to proceed with patenting and commercialization significantly vary between cases and circumstances.The handbook has been prepared within the EU-project Biomarker Commercialization (BIC) comprising 9 partners in the Baltic Sea Region (BSR) united with the same challenges, as well as the common objective of more efficiently bringing new and better IVD-applicable biomarkers from discovery into clinical use. The project's budget is EUR 2.55 million and is co-financed by the European Regional Development Fund through the Interreg Baltic Sea Region Programme with EUR 1.96 million

Integrated Acoustic Separation, Enrichment, and Microchip Polymerase Chain Reaction Detection of Bacteria from Blood for Rapid Sepsis Diagnostics

This paper describes an integrated microsystem for rapid separation, enrichment, and detection of bacteria from blood, addressing the unmet clinical need for rapid sepsis diagnostics. The blood sample is first processed in an acoustophoresis chip, where red blood cells are focused to the center of the channel by an acoustic standing wave and sequentially removed. The bacteria-containing plasma proceeds to a glass capillary with a localized acoustic standing wave field where the bacteria are trapped onto suspended polystyrene particles. The trapped bacteria are subsequently washed while held in the acoustic trap and released into a polymer microchip containing dried polymerase chain reaction (PCR) reagents, followed by thermocycling for target sequence amplification. The entire process is completed in less than 2 h. Testing with Pseudomonas putida spiked into whole blood revealed a detection limit of 1000 bacteria/mL for this first-generation analysis system. In samples from septic patients, the system was able to detect Escherichia coli in half of the cases identified by blood culture. This indicates that the current system detects bacteria in patient samples in the upper part of the of clinically relevant bacteria concentration range and that a further developed acoustic sample preparation system may open the door for a new and faster automated method to diagnose sepsis