The Future of AST with Volpi

The global health landscape is facing a significant challenge with the rise of antimicrobial resistance (AMR), which now results in a higher annual death toll than malaria. In response, there is a growing need for rapid and accurate identification and antimicrobial susceptibility testing (ID/AST). The days-long wait for results from traditional AST methods is becoming increasingly impractical. Volpi is responding to this need by advancing towards a new standard in diagnostic technology. By incorporating AI and optical technologies and advancing rapid AST processes that provide results within hours, Volpi strives to improve the efficacy and cost-efficiency of ID/AST platforms. This initiative is crucial for ensuring timely and appropriate treatments for patient care and combating the spread of AMR.  

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Antimicrobial resistance is a fast-growing and concerning healthcare issue that impacts global health significantly. In 2019*, 1.27 million deaths were attributable to AMR in 204 countries, about double the number of deaths caused by malaria in the same period. 

(*https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext)

Identification and antimicrobial susceptibility testing (ID/AST) are critical components of modern healthcare, but the traditional methods have significant limitations. From the time of specimen collection, it usually takes one day to determine Gram-positive (GP) and Gram-negative (GN) bacteria, two days to identify the pathogen and three days to obtain antimicrobial susceptibility test (AST) reports. In other words, it takes at least three days for a suspected case to be diagnosed and more time until a specific antibiotic can be provided.  This is mainly because conventional testing methods require three overnight culture steps. The 72-hour turnaround time does not consider delays associated with a lack of weekend or overnight coverage by the staff, further highlighting the need for more efficient solutions**.  

(**https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258864/)

Other tests, such as Mass Spectrometry (MS) or Nucleic Acid Amplification Tests (NAATs), are paving the way for the future of microbial ID. These tests can identify microbes directly from samples without the need for culturing, thanks to their intrinsically higher sensitivities. This opens exciting possibilities for faster and more accurate diagnosis and treatment. 

However, less than 47 percent of patients globally*** have access to routine diagnostic testing, and only roughly one percent have access to culture. 

(*** https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(21)00673-5.pdf)

The Volpi team visited the ESCMID and Uppsala Antibiotic Days this year to discuss innovation, novel technologies and rapid ID/AST testing approaches with industry specialists and opinion leaders. Allowing for the quick and accurate diagnosis of infections and determining the most effective treatment directly from whole blood in hours instead of days remains a challenge several companies are trying to solve.  

Some companies combine microfluidics, digital multi-modal imaging and artificial intelligence (AI) to develop solutions that deliver reliable ID/AST test results from whole blood within six to eight hours. Others provide MIC values directly from positive blood cultures in two to four hours using very different techniques, ranging from digital imaging to flow cytometry. 

Multiple firms are pioneering rapid AST, delivering results in less than two hours. Notably, Sysmex Astrego, recipient of the UK’s Longitude Prize for AMR efforts, alongside PhAST Diagnostics and FASTinov, are at the forefront of this innovation. 

At Volpi, we have extensive expertise in developing instrumentation for colorimetry, nephelometry, fluorometry, flow cytometry and multi-modal digital imaging. Using our lab infrastructure, including BSL2 labs, we transfer customer assays and run early microbiological tests on our custom-developed modules for de-risking purposes. Additionally, we provide data analysis and AI-based solutions designed to enhance the performance and cost-effectiveness of ID/AST platforms. Our goal is to mitigate risks and expedite the product development process. 

One of our development teams successfully developed a custom optical-based measurement solution for an ID/AST testing leader. The solution improved detection sensitivity and reliability while decreasing the cost of their existing platform.  Our ability to increase (by orders of magnitude) the sensitivity was a true game changer for our customers, opening the door for developing new algorithms for more rapid AST testing.  

Recently, we sat down with Dr. Harald Kraushaar, Volpi’s VP of Global Business Development, to discuss Volpi’s contributions in this field. 

Harald, you recently attended both ECCMID/ESCMID 2024 and Uppsala Antibiotic Days.  Can you please share your impressions of these events?  

Although both events differed in scope and audience, one key theme was present in both: ID/AST testing, methods, challenges and applications.   

One aspect that struck me was the relative complacency towards AMR, especially when compared to the global response to diseases like cancer. It’s clear that strategic communication and marketing are essential to elevating AMR on the agendas of policymakers, authorities and the public.  The development of rapid AST technologies offers hope for faster diagnostics. However, the current underutilization of these tools is a multifaceted issue that requires tackling from various angles, including economic, educational and incentivization for healthcare professionals. 

Can you tell us more about Volpi’s work in this area? 

We are involved in several projects within the ID/AST, focusing on supporting companies as they develop solutions that can make a meaningful difference. 

For example, a leading company in the ID/AST space approached Volpi, needing our deep-seated expertise in the design of sophisticated optical modules. We enthusiastically accepted the project, driven by two key motivations. The first is our commitment to Volpi’s mission—to help create a positive impact on people’s health. The second is our affinity for complex technical work, which this project offers in abundance, fuelling our enthusiasm for overcoming challenging engineering feats. 

Our customer wanted a newer version of the optical detection module, with a much higher sensitivity and larger dynamic range at a lower cost while enabling retrofitting in their installed base of instruments. As you can imagine, retrofitting added constraints to our solution, making the project quite challenging. Nonetheless, the project team was motivated and, in the spirit of Volpi’s culture, embraced the opportunity to make a significant impact in the ID/AST space.   

What was critical in the project to ensure successful completion?   

Our project’s success hinged on our Agile methodology, which was perfectly aligned with our customer’s approach. We operated in two-week sprints and eight-week increments, with a core project team of experts in systems, optics, mechanical and electrical design, and an extended team to ensure quality and efficiency. The solution was designed at our Swiss site in Dietikon near Zurich and transferred to our US site in Auburn, New York, for manufacturing. This collaborative working model allowed us to deliver an end-to-end, cost-effective solution with superior performance in a seamless manner and with minimal effort from the customer. 

How did Volpi ensure the quality and consistency across many optical modules?  

We developed a comprehensive calibration process and tools, including solid-state calibration plates that can be stored at room temperature and used in production to decrease the cost of quality. This proved pivotal in optimizing our quality control process for the optical module from prototype to pilot series, ensuring the timely completion of each phase. 

What differentiated Volpi from other suppliers in this project?   

Our customer chose Volpi due to our strong reputation for creating custom optical solutions for the IVD industry. They needed a partner with deep-seated expertise and ancillary capabilities to create a reliable, high-quality, next-generation ID/AST solution. We provided comprehensive application testing, data analysis and cutting-edge engineering to meet our customers’ specific needs. We are a supplier and an innovation partner committed to transforming healthcare with fast and accurate ID/AST. 
 

We leverage our expertise in optical measurement technology and our ability to integrate hardware and software to deliver high-performance, cost-effective solutions. We don’t just work for our clients—we work with them as partners, valuing their input and understanding their requirements to develop customized solutions that meet their needs.