Safeguarding the effectiveness of antibiotics for generations to come

Q-linea is a company of thinkers and makers who develop solutions for improved infection diagnostics. Since 2008, we have worked hard to create innovative technologies with a keen focus on improving sepsis treatment while reducing antibiotic resistance.

In the scientific and innovative environment of Uppsala University in Sweden, our founders had the idea for a biosecurity application. It would be based on proprietary (non-PCR) technologies for molecular identification of bacteria, mainly for detecting biological warfare agents (such as anthrax and smallpox). Shortly after, a small office was rented and three people were hired to develop this idea. Q-linea was born.

We also made our first big investment: a coffee machine.

Now you might be wondering how a company that was developing systems for detecting biological warfare agents ended up developing a rapid AST (antimicrobial susceptibility testing) system. The story is not as complicated as it sounds.

We realized that our years of knowledge could be put to good use in the field of AST and envisioned a system that could test directly from positive blood cultures to offer an unmatched value for microbiologists, clinicians, and patients. Something not just evolutionary, but revolutionary.

Leadership

It is a great honor to be joining the Q-linea team at this key juncture for the Company. As incoming CEO as of 1 March 2024, I have had the opportunity to witness the fruits of significant achievements made during 2023 on all fronts. Most notably, how the Company has laid the groundwork for the coming phase of commercialisation of our flagship ASTar rapid AST testing platform.

We are in a period of transition now, moving from a focus on the development and launch of a novel technology with great clinical promise to the methodical commercialisation of a solution for our laboratory and clinical users. Significant investments were made in 2023 which have opened key markets across Europe and created the basis for commercial activities in the US once we have secured FDA clearance.

With more than a decade of development and clinical testing behind us, the ASTar platform is ready to lead the market in the next generation of antimicrobial susceptibility testing. We are proud to announce our commercial installation in Italy, at Tor Vergata Hospital.

In 2024, my focus will be on anchoring ASTar with our customers and accelerating our commercialisation. We are energised by the signals we are receiving from customers, including pre-market interactions with leading hospital and reference lab groups in the US who are eagerly awaiting our FDA clearance. We initiated two Early Access Programs in the US during 2023 and anticipate more placements through 2024. growing interest and anticipate orders for the ASTar platform through 2024.

I am excited to lead Q-linea during this next phase of our journey, and committed to delivering on our mission for patients, and thereby our value promise to customers, employees and shareholders

Stuart Gander

President & CEO, Q-linea Group

ASTar®

ASTar is a fully automated, rapid phenotypic antimicrobial susceptibility testing (AST) system built on the gold standard broth microdilution method. It serves as a complete microbiology laboratory within a single benchtop instrument and two consumables, minimizing laboratory footprint.

Streamline your laboratory workflow and get a head start on your workday.

Product is FDA cleared. Availability of product in each country depends on local regulatory marketing authorization status.

Fast: ASTar is a rapid AST system that delivers full AST reports in approximately six hours and effortlessly handles even the heaviest workloads.
Easy: ASTar requires less than two minutes of hands-on time and has a simple three-step workflow where all stages of inoculum preparation and susceptibility testing are handled for you. All you need to do is:
Future Proof: The ASTar software is kept up to date using the latest regulatory breakpoints, ensuring that ASTar is an invaluable tool in the ever-evolving world of antimicrobial treatments and antimicrobial resistance.

CMS proposes to approve the ASTar system for NTAP funding

Q-linea AB (publ) (OMX:QLINEA) announces that CMS has determined that the ASTar system meets the cost criterion to qualify for NTAP funding.

Q-linea applies for a NTAP code for the US market

The Centers for Medicare & Medicaid Services (CMS) offers manufacturers the ability to apply for a NTAP code, providing additional payment to hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount. A product’s NTAP designation lasts for no more than 3 years for a specific indication.

Strong ASTar results presented at AMCLI

Early study results show ASTar prompted antibiotic therapy modifications in up to 45% of septic patients and enabled appropriate care 20 – 34 hours earlier than current standard-of-care.

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