BASEL, Switzerland -- Swiss based Hutman Diagnostics AG together with its Canadian partner Axela Inc. have reached a significant goal in their nucleic acid based infectious disease detection program referred to as Alena Diagnostics. Together they successfully demonstrated multiplex detection of pathogens in a new, low cost cartridge format at levels of sensitivity, specificity and inclusivity necessary for commercial success.
For this study, infected clinical samples were obtained from Hutman's network of microbiology laboratory partners in the Czech Republic, Germany, United Kingdom and Switzerland. Previously, rapid and sensitive detection of pathogens had been demonstrated using Axela's bench top Ziplex platform. This instrument uses proprietary flow though arrays in a TipChip format to efficiently hybridize and detect over 100 targets simultaneously. These new samples were tested in parallel on Ziplex and prototype next generation cartridge systems from Axela. Flow though arrays in both cases were designed using probes against novel bacterial targets derived from Hutman's internal development process. The new platform provided equal or superior results to the laboratory system but in a simple, cartridge format suitable for Point of Use applications. Having demonstrated this technical performance, Alena is now targeting initial product commercialization within 15-18 months.
The Alena value proposition is compelling whether compared to existing culture based or competitive nucleic acid detection systems. The Alena platform will be capable of multiplexing in excess of 100 pathogens on a single chip (see picture), including bacterial resistances to antibiotics and providing sample to answer results while the patient is still undergoing initial evaluation. Novel fluidics facilitate full automation in an inexpensive to manufacture consumable. The low capital cost of the instruments will allow Alena products to compete in broad infectious disease markets.
Initial applications include endocarditis, bone and joint infections, abscesses, meningitis and sepsis, as well as the detection of the most prevalent antibiotic resistances. The platform's potential to provide rapid and cost effective pathogen screening in a near patient environment will represent a breakthrough in clinical protocols and patient outcome…. saving lives and reducing costs.
Hutman Diagnostics AG, founded in January 2011 and EN ISO 13485 certified since February 2015 is an in vitro diagnostics product development company, specialized on DNA based applications from patient samples, which we collect through our extended network of microbiology laboratories.
Axela's core expertise in flow-through microarrays and multiplex assay development serves as the foundation for novel molecular diagnostic solutions. Its technologies are adaptable to point-of-care and traditional laboratory testing needs. Superior performance has been demonstrated in allergy, oncology, infectious disease, and neurology specialties among others. Axela partners with diagnostic companies and laboratories to commercialize clinical tests and develop custom market and application based solutions.