We are entering 2020 with high momentum and important goals

Q-linea signs global partnership with Thermo Fisher Scientific for commercialization of ASTar intensifies ahead of ASTar launch

We are thrilled to be working with Thermo Fisher 

We are pleased to present an important commercial milestone for both companies. The interest in commercializing ASTar® has been very strong from a number of global companies. We are thrilled to be working with Thermo Fisher Scientific™ and especially appreciate their global reach. We share a common market view and agree on how infection diagnostics can be improved.

Thermo Fisher Scientific will have the exclusive right to offer ASTar to the market in all geographies, with the exception that Q-linea can co-market in the Swedish market. The partnership is exclusive to both companies regarding fast AST testing. The two companies will work closely together to provide customers with a comprehensive AST portfolio.

Together with our sub-supplier, we also made good progress in solving the component problem that was identified at the beginning of the quarter. On top of this, our entire production team has been working diligently to prepare for our move to new product premises on Palmbladsgatan in Uppsala. We also found time to take part in important conferences, anchor our health economics studies and continue preparing for our regulatory studies.

Company is growing according to plan

The company is developing according to plan, and we were able to strengthen our team during the quarter through the addition of Q-linea’s first official service technicians. The goal is to have a service organisation in place in ample time before the launch to give the organisation time to be fully prepared to assist our customers. In the autumn, we strengthened our commercial organisation, and while the marketing team will continue to grow according to plan, it is now ready to begin serving customers as planned.

In November, we exhibited at the Federation of Infection Societies Conference (FIS) in Edinburgh. The UK is far more advanced in terms of infection diagnostics and antimicrobial resistance, and the positive feedback that we received, particularly on our comprehensive antibiotics panel, will be invaluable on the road ahead.

In October, we noted that there was an issue with an important component from a third-party manu-facturer. In collaboration with the supplier, we were able to quickly identify and complete the minor modifications and improvements that were required. We have now thoroughly tested the solution on several systems that subsequently operated for two months without any issue. Additional systems are on their way for verification testing. We would, however, like to see a number of additional systems that have operated without any issue for at least one month at our new microbiology lab—thereby recreating the same conditions as would exist at the customer’s site—before we can dismiss the issue entirely, but the status looks undeniably positive.

Looking forward to an exciting year

The CE marking process of ASTar continues and our clinical studies are expected to begin during the second half of 2020 as previously announced. During the quarter, tests were carried out on ASTar, such as electrical safety and electromagnetic compatibility (EMC) testing, resulting in more than satisfactory results.

We are entering 2020 with high momentum and important goals. We are looking forward to the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Paris and the chance to, alongside our commercial partner, unveil ASTar to the market. Our clinical and health economics studies will commence during the year. We will present ASTar to the market and the work ahead of launch are scheduled to begin in conjunction with ECCMID. It will truly be an exciting year and I look forward to the journey ahead alongside all of you.

Uppsala, February 2020,
Jonas Jarvius, President

Source: YEAR-END REPORT 1 JANUARY – 31 DECEMBER 2019

I look forward to the journey ahead alongside all of you.  

We are thrilled to be working with Thermo Fisher 

We are pleased to present an important commercial milestone for both companies. The interest in commercializing ASTar® has been very strong from a number of global companies. We are thrilled to be working with Thermo Fisher Scientific™ and especially appreciate their global reach. We share a common market view and agree on how infection diagnostics can be improved.

Thermo Fisher Scientific will have the exclusive right to offer ASTar to the market in all geographies, with the exception that Q-linea can co-market in the Swedish market. The partnership is exclusive to both companies regarding fast AST testing. The two companies will work closely together to provide customers with a comprehensive AST portfolio.

Together with our sub-supplier, we also made good progress in solving the component problem that was identified at the beginning of the quarter. On top of this, our entire production team has been working diligently to prepare for our move to new product premises on Palmbladsgatan in Uppsala. We also found time to take part in important conferences, anchor our health economics studies and continue preparing for our regulatory studies.

Company is growing according to plan

The company is developing according to plan, and we were able to strengthen our team during the quarter through the addition of Q-linea’s first official service technicians. The goal is to have a service organisation in place in ample time before the launch to give the organisation time to be fully prepared to assist our customers. In the autumn, we strengthened our commercial organisation, and while the marketing team will continue to grow according to plan, it is now ready to begin serving customers as planned.

In November, we exhibited at the Federation of Infection Societies Conference (FIS) in Edinburgh. The UK is far more advanced in terms of infection diagnostics and antimicrobial resistance, and the positive feedback that we received, particularly on our comprehensive antibiotics panel, will be invaluable on the road ahead.

In October, we noted that there was an issue with an important component from a third-party manu-facturer. In collaboration with the supplier, we were able to quickly identify and complete the minor modifications and improvements that were required. We have now thoroughly tested the solution on several systems that subsequently operated for two months without any issue. Additional systems are on their way for verification testing. We would, however, like to see a number of additional systems that have operated without any issue for at least one month at our new microbiology lab—thereby recreating the same conditions as would exist at the customer’s site—before we can dismiss the issue entirely, but the status looks undeniably positive.

Looking forward to an exciting year

The CE marking process of ASTar continues and our clinical studies are expected to begin during the second half of 2020 as previously announced. During the quarter, tests were carried out on ASTar, such as electrical safety and electromagnetic compatibility (EMC) testing, resulting in more than satisfactory results.

We are entering 2020 with high momentum and important goals. We are looking forward to the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Paris and the chance to, alongside our commercial partner, unveil ASTar to the market. Our clinical and health economics studies will commence during the year. We will present ASTar to the market and the work ahead of launch are scheduled to begin in conjunction with ECCMID. It will truly be an exciting year and I look forward to the journey ahead alongside all of you.

Uppsala, February 2020,
Jonas Jarvius, President

Source: YEAR-END REPORT 1 JANUARY – 31 DECEMBER 2019

I look forward to the journey ahead alongside all of you.