Q-linea AB has received the official response including a number of clarifications and very positive feedback from the US Food and Drug Administration, FDA, regarding the company’s planned pivotal clinical trial with ASTar in the United States.
Jonas Jarvius, the CEO of the company is very pleased with the official feedback from the FDA which will have a very positive impact on the conduct of Q-linea’s clinical study in the US. We Jarvius said the company has received the clear guidance it wanted and the study can be carried out in a more straightforward way than previously estimated, as the FDA offers the possibility for Q-linea to perform parts of the study itself. Jarvius said this is good news that might also have benefits regarding the study’s total cost and timeline. “We also see that the feedback from the FDA could further improve the ASTar system’s competitiveness,” Jarvius added.
Q-linea said in the press release that the FDA was positive to the proposed study design and also pointed to a new regulatory approach to include organism-antibiotic combinations for which there are currently no FDA-approved breakpoints. A prerequisite for getting these new combinations approved is that the applicant can demonstrate a clinical need and scientific support, Q-linea said. The company estimates it could become one of the first manufacturers to take advantage of this opportunity, which would further strengthen its product offering in the USA, it said.
Furthermore, the FDA was positive to reducing the number of samples in the clinical performance study for certain low prevalence organisms, the company said. This specifically applied to an organism that requires an enriched culture medium (fastidious supplement), it said in the press release.
“Of course, we are pleased that the FDA is opening up to this opportunity and this means that our ability to analyze fastidious and non-fastidious organisms in the same test in full can benefit patients”, said the CEO.
The pivotal study with ASTar relates to the clinical and analytical performance of the system and will be conducted on at least three sites – two in the US and one in Europe, of which one is expected to be Q-linea’s microbiology laboratory in Uppsala. The company expects the study to start in the second half of 2020.