Q-linea AB (publ) (OMX: QLINEA) today announces the company has received 510(k) clearance from the US FDA for its expanded ASTar® Gram-negative Blood Culture menu.
The expanded panel represents a significant increase in clinical utility with 93 new bug-drug combinations to a total of 215, approximately 75% more than the Version 1 panel, including key new drugs such as Ceftriaxone, Cefotaxime, Ceftolozane-tazobactam and Ertapenem. In addition, performance has been upgraded with new algorithms for some previous combinations, eliminating many former limitations of the panel.
The Version 2 panel now conforms to all the latest FDA breakpoints, making it the most up-to-date solution available on the market for laboratories and clinicians.
“This menu provides the most comprehensive phenotypic susceptibility data available on the market for physicians deciding on critical therapeutic treatment for patients with Gram-negative blood stream infection and severe sepsis. Reducing time to optimal, targeted antibiotic therapy is crucial to improve individual patient outcomes and minimize the development of novel antibiotic resistance”, says Vikas Gupta, Senior Director of Clinical Affairs for Q-linea.
“Our FDA-cleared panel now closely matches what ASTar already provides to patients in Europe and other markets under CE-IVDR clearance”, adds Stuart Gander, CEO for Q-linea. “We look forward to providing patients in the US with the full power of the ASTar platform to improve outcomes and reduce costs for healthcare systems.”