Policy & Regulation
Q-linea's first product expected to reach its main market earlier than planned
15 March 2019 -

Q-linea AB (STO:QLINEA) announced on Thursday that the company's first product, ASTar, is expected to launch in the company's main market, the US, three to four months earlier than communicated, to take advantage of strong market interest and positive feedback from the US Food and Drug Administration, the US FDA.

The European launch is thus postponed to the same extent.

According to Q-linea, in its discussions with potential sales partners, increasing emphasis has been placed on the US market. Against this background, and because of the positive feedback Q-linea received from the US FDA, indicating that data could be shared between the European and the US study, Q-linea has decided to change its launch strategy.

As a result of the company's increasing focus on the US market, efforts in Europe will be postponed three to four months.

According to the company, this new strategy means that it will plan to conduct a joint study for the European and American markets. The European study will therefore be carried out somewhat later than previously communicated, while the American study, which the company considers more urgent, is implemented earlier than planned.

Overall, Q-Linea expects to achieve a larger turnover faster, despite a quarterly postponement of the European study.

Reportedly, Q-linea had previously received positive feedback from the FDA regarding the proposed clinical study for the US market. This means that data collected at one of the European hospitals can probably be used in the American study. A prerequisite is that the FDA approves the clinical study protocol, which Q-linea estimates could take place following an adaptation to the US requirements.

Q-linea expects to submit data to the FDA in April 2020, three to four months earlier than communicated. Data will be partly based on the European study. The plan is now to launch ASTar in Europe in connection with the world's largest infection diagnostic conference ECCMID, held in Paris in April 2020.

Q-linea is a research, development and manufacturing company that

primarily develops instruments and disposables for rapid and reliable infection diagnostics.