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Q-linea develops instruments and disposables for rapid infection disease diagnostics. The Sepsis is a global health problem, afflicting as many as 30 million people every year, and a major driver of hospitalization costs. Antimicrobial Resistance requires rapid diagnostics for correct treatment of sepsis. Our core product ASTar is a fully automated instrument for measuring bacterias antimicrobial susceptibility (rapid antimicrobial susceptibility testing, rAST), delivering results ~20-48 earlier than standard of care with a fully automated workflow. This gives substantial health economic benefits: Patients up to 40%lower mortality rates; Society Less pressure for resistance and superinfections; Hospital/government ~$2,500 to $20,000 cost savings per patient. ASTar is a proven technology leader as evidenced by user feedback and tender evaluations. The first CE-IVDR and FDA approved test on ASTar is a high-value rAST on Gram-negative blood cultures from patients with suspected sepsis. This has been received well by customers, as evidenced by customer feedback, volume of commercial evaluations and sales. In order to achieve broader market penetration, additional tests are needed on the menu, as well as commercial and production ramp up. Non European competitors, while not technologically leading, receive substantial government funding for development, enabling them to move quickly. The proposed project would bring added tests for Gram-positive blood cultures as well as clinical isolates to the menu, encompassing >90% of typical lab needs, and provide commercial and production scale-up to meet emerging demand in a timely manner.
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