Big step towards the US-market
“There was a wealth of positive news for Q-linea in the second quarter of 2022, above all strong interest from potential customers.”
Feedback from potential customers was positive at ECCMID (the European Congress of Clinical Microbiology and Infectious Diseases) in Lisbon, Portugal on 23–26 April and at the US equivalent to ECCMID, ASM Microbe (American Society for Microbiology), in Washington DC on 9–13 June. At ECCMID, we presented our Podler® blood culture technology in its entirety for the first time as well as the possibility of running isolate discs in ASTar using a separate loading station.
We received more than 100 expressions of interest in ASTar at ASM Microbe, which was far higher than our internal target. We are overwhelmed by this level of interest, given that ASM Microbe is a smaller conference than ECCMID and that ASTar is not yet commercially available in the US. On the whole, the level of interest in ASTar exceeded all of our internal targets, and our partner, Thermo Fisher Scientific, had a full house at its ASTar booth at both conferences.
We see that the great interest should generate a positive development in sales during the next year and that we are currently sticking to the previously communicated sales forecast for the year. The sales process is long, and our assessment is that 2022 will be a difficult year. However, our goal is long-term and the interest in ASTs and successful evaluations is a good foundation for the future.
One catalyst for the high degree of interest is that we are approaching market approval in the US. Just before ASM Microbe, we submitted a 510(k) application to the FDA to gain US market authorisation. Since we received a Breakthrough Device designation in April this year, we hope that the FDA will expedite the regulatory review of our application.
This designation is given to products that are deemed to provide a more efficient treatment for serious illnesses where no comparable alternative is available in the market. The aim of the designation is to accelerate the regulatory review of new medical devices and provide patients with faster access to new treatment alternatives.
Our market application contained over 2,000 pages, partly due to our broad panel, which makes the application very extensive. The FDA will contact us during the summer. Normally the process takes 90 days, but the pandemic is still having repercussions, and the clock stops if the FDA asks a question. However, we are cautiously optimistic, and given our Breakthrough Device designation we hope for an interactive, prioritised process.
During the quarter, we received a letter of intent (LOI) from a large market-leading company for an evaluation and potential commercialisation partnership for our Podler blood culture technology. The traditional blood culture market is dominated by a small number of large companies and entering into a letter of intent with one of them is a positive first step in the commercialisation of the Podler technology. The LOI is proof of the serious interest we are seeing in our technology, and if the evaluation goes well it could lead to more extensive commercial discussions.
In May, we announced that we achieved In Vitro Diagnostics Regulation (IVDR) status for the ASTar instrument. The transition from the IVD Directive to the IVD Regulation (IVDR) is the largest change in the regulation of diagnostic products in Europe in decades. The regulation makes the European system more like the American system, with more extensive tests in order to meet regulatory requirements. We were very proud to have met the demands for CE/IVDR marking for the ASTar instrument, and we are currently working to gain IVDR status for the ASTar BC G-Kit, which we have about five years to accomplish.
Based on all of our positive news and the high level of interest from potential customers, I am very optimistic about the future. We look forward to our future launch of ASTar in the US, and to seeing ASTar contribute to improved patient outcomes for as many patients as possible around the world in the long term.
We are also seeing our staffing needs beginning to level off for the first time since the Company was started. This is primarily because we have used consultants at the Company in order to reach important milestones (IVDR, 510k, etc.). As we have passed these milestones and are also able to transfer knowledge to our personnel, we are now able to reduce the use of consultants. Naturally, it is a positive development to be able to deliver more without needing to grow at the same pace as before.
Uppsala, 13 July 2022, Jonas Jarvius, President