Q-linea announces FDA submission for expanded claims for ASTar® BC G- panel
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Q-linea AB (publ) (OMX: QLINEA) today announces their FDA 510(k) submission for expanded organism and antimicrobial claims on their ASTar BC G- panel, improving the clinical utility of the panel for patients with bacteremia and sepsis by offering more escalation and de-escalation agents as well as increased pathogen coverage.
This submission follows the completion of a clinical trial, conducted at two prestigious US institutions as well as Q-linea’s headquarters in Sweden. The intention of the submission is to bring the FDA-cleared version of the panel in line with the successful IVDR panel, currently available in the EU and in use in many clinical settings.
US adoption of the current panel is on the rise, and the second FDA clearance, anticipated in the spring of 2026, is expected to accelerate ASTar’s use.
Jim Kathrein, VP of US Commercial Operations, stated, “We are thrilled with the data coming out of this clinical trial and look forward to an expanded menu being FDA cleared in the spring.”