Strong study results and virtual presentation of ASTar

After an intense quarter – during a year marked by the coronavirus pandemic – I am pleased to present Q-linea’s progress in its efforts to bring its keyproduct, ASTar, to market.

 

The pandemic has naturally affected the mood at Q-linea, but we have thankfully been spared most of its direct and indirect effects. While the situation could certainly change as more countries relax their travel and social distancing restrictions, we remain cautiously positive.

Despite the challenges of the pandemic, such as the need to conduct digital meetings rather than in-person meetings, our collaboration with Thermo Fisher Scientific is progressing very well and according to plan. We have held frequent meetings, during which our collaboration has been intensified and expanded. Those who follow Thermo Fisher Scientific’s work in microbiology know that the company is doing exciting things in the field, and we see clear synergies with ASTar.

During the quarter, we held our first market presentation of ASTar, during which we shared a little more information about the underlying technology. Our aim is to show how well-thought-out ASTar is in order to convincingly demonstrate the major benefits it will offer. The presentation is still available on our website, and the overall response has been highly positive.

In May, we announced excellent results from a prospective patient study conducted together with the laboratory for clinical microbiology at Uppsala University Hospital. We are pleased that the study could be carried out despite these challenging times for healthcare.

In the study, ASTar analysed samples from 17 patients and the antibiotic panel consisted of 29 antibiotic preparations, covering both fastidious1 and non-fastidious bacteria. The results (Essential Agreement: 94.5%, Categorical Agreement: 97.3%) were well above the regulatory requirements for the EU and the US (at least 90% in both categories).

These strong results and our positive collaboration bode well for the major prospective performance study involving 80 to 100 patients to be carried out in the autumn. In addition, we can also announce that we have signed a contract with Uppsala University Hospital to be the first hospital involved in the study. This study will form part of the documentation in the ongoing process for CE-IVD approval and submission to the FDA. We have numerous ASTar units in operation at our laboratory and a number of other activities under way ahead of the clinical studies. We plan to begin analytical and clinical validation during the second half of the year.

The prospective clinical part of the study is expected to take approximately three months and will initially start in Europe, since US sites are still closed. We are currently reviewing the design of the US study. A portion of the study may be carried out internally following a response by the FDA, and Thermo Fischer Scientific may be able to help us gain access to US laboratories, but all of this naturally depends on the development of the coronavirus pandemic.

At the Annual General Meeting in May, Mario Gualano was elected as a new director of the company. Mario has an extremely impressive background. With over 25 years of experience in the microbiology and diagnostics industry – the last 15 of which he spent at Thermo Fisher Scientific – he is an enormous asset for Q-linea. I feel humbled and thankful that we have succeeded in attracting such a leading expert and see this as an important step for us as a company.

In summary, I am proud of what we achieved during the quarter and know that we still have an interesting and intense journey ahead of us. During the quarter, we carried out a directed issue that raised gross proceeds of SEK 270 million for the company. This money will primarily be used for the commercialisation of ASTar. I would like to take this opportunity to thank our owners – both old and new – for the confidence you have shown in us and I look forward to continuing this journey with you all.

Uppsala, July 2020,

Jonas Jarvius, President

I am proud of what we achieved during the quarter and know that we still have an interesting and intense journey ahead of us.

 

The pandemic has naturally affected the mood at Q-linea, but we have thankfully been spared most of its direct and indirect effects. While the situation could certainly change as more countries relax their travel and social distancing restrictions, we remain cautiously positive.

Despite the challenges of the pandemic, such as the need to conduct digital meetings rather than in-person meetings, our collaboration with Thermo Fisher Scientific is progressing very well and according to plan. We have held frequent meetings, during which our collaboration has been intensified and expanded. Those who follow Thermo Fisher Scientific’s work in microbiology know that the company is doing exciting things in the field, and we see clear synergies with ASTar.

During the quarter, we held our first market presentation of ASTar, during which we shared a little more information about the underlying technology. Our aim is to show how well-thought-out ASTar is in order to convincingly demonstrate the major benefits it will offer. The presentation is still available on our website, and the overall response has been highly positive.

In May, we announced excellent results from a prospective patient study conducted together with the laboratory for clinical microbiology at Uppsala University Hospital. We are pleased that the study could be carried out despite these challenging times for healthcare.

In the study, ASTar analysed samples from 17 patients and the antibiotic panel consisted of 29 antibiotic preparations, covering both fastidious1 and non-fastidious bacteria. The results (Essential Agreement: 94.5%, Categorical Agreement: 97.3%) were well above the regulatory requirements for the EU and the US (at least 90% in both categories).

These strong results and our positive collaboration bode well for the major prospective performance study involving 80 to 100 patients to be carried out in the autumn. In addition, we can also announce that we have signed a contract with Uppsala University Hospital to be the first hospital involved in the study. This study will form part of the documentation in the ongoing process for CE-IVD approval and submission to the FDA. We have numerous ASTar units in operation at our laboratory and a number of other activities under way ahead of the clinical studies. We plan to begin analytical and clinical validation during the second half of the year.

The prospective clinical part of the study is expected to take approximately three months and will initially start in Europe, since US sites are still closed. We are currently reviewing the design of the US study. A portion of the study may be carried out internally following a response by the FDA, and Thermo Fischer Scientific may be able to help us gain access to US laboratories, but all of this naturally depends on the development of the coronavirus pandemic.

At the Annual General Meeting in May, Mario Gualano was elected as a new director of the company. Mario has an extremely impressive background. With over 25 years of experience in the microbiology and diagnostics industry – the last 15 of which he spent at Thermo Fisher Scientific – he is an enormous asset for Q-linea. I feel humbled and thankful that we have succeeded in attracting such a leading expert and see this as an important step for us as a company.

In summary, I am proud of what we achieved during the quarter and know that we still have an interesting and intense journey ahead of us. During the quarter, we carried out a directed issue that raised gross proceeds of SEK 270 million for the company. This money will primarily be used for the commercialisation of ASTar. I would like to take this opportunity to thank our owners – both old and new – for the confidence you have shown in us and I look forward to continuing this journey with you all.

Uppsala, July 2020,

Jonas Jarvius, President

I am proud of what we achieved during the quarter and know that we still have an interesting and intense journey ahead of us.