What happens between identifying a clinical need and obtaining a diagnostic result that can inform patient care? And how can laboratories get useful information to the people who need it sooner?
These questions connected the presentation at From Insight to Impact, our inaugural fungal symposium, held on 27 October 2026 at Basecamp Utrecht. Hosted by PathoNostics, the Lunch & Learn brought together almost 40 attendees to explore the evidence, methods and practical decisions shaping fungal diagnostics. The programme moved from the work behind IVDR compliance to C. auris screening, resistance detection and the evolving diagnostic landscape.
There was plenty to discuss outside the presentation room too. Conversations continued over lunch, attendees were in high spirits, and the venue’s swinging chairs provided a memorable setting for exchanging ideas.
Antoinette Brink opened the scientific programme by explaining the work required to take a clinical need through development to an IVDR-compliant diagnostic. Her presentation brought an often less visible part of diagnostics into focus: the evidence and controls behind the result.
Antoinette outlined three distinct elements of performance evaluation:
- Scientific validity: establishing the relationship between the target being measured and the clinical condition.
- Analytical performance: demonstrating that the assay detects or measures its target as claimed.
- Clinical performance: demonstrating that the results provide the intended information in the relevant clinical context.
Together, these address different questions about a diagnostic’s purpose and performance. Reliable detection under controlled conditions is one part of a wider evidence package that must support the assay’s intended use. Antoinette briefly followed the five development stages—preparation, feasibility, development, verification and clinical validation—through to independent notified-body assessment. Studies examine factors including detection limits, specificity, interference and reproducibility, alongside clinical performance and usability.
For PathoNostics, the session demonstrated the substantial commitment involved in developing new products under this framework: controlled processes, documented evidence and independent scrutiny.
A central learning was that this commitment continues after certification. Routine performance, complaints, customer feedback, scientific developments and emerging risks all need to be reviewed. Findings can lead to updated evidence, corrective actions or changes to the product and its supporting documentation.
For laboratories, this makes ongoing communication with manufacturers valuable. Experience at the bench contributes to understanding how a diagnostic performs throughout its lifecycle.
The takeaway: IVDR compliance represents an ongoing commitment to evidence and performance, extending well beyond the point of product launch.
Eelco Meijer explored how healthcare institutions can strengthen their response to C. auris, connecting diagnostic findings with screening and isolation decisions. The inclusion of C. auris in Dutch SRI guidance on multidrug-resistant organisms is an important development. However, institutions still need to establish workable pathways around whom to screen, which locations to sample, how to test and how results should inform action. Eelco’s presentation highlighted why the sampling strategy and diagnostic method need to be considered together.
In the PCR screening analysis he presented, combined axilla/groin sampling detected approximately 80% of PCR-positive patients. A four-location combination—axilla/groin, the perineal region, nose and throat—detected approximately 98%. These figures describe the findings within the presented study population. They illustrate how a screening strategy can miss carriers when it relies on a limited set of sampling locations, even when a sensitive diagnostic method is used. Eelco’s recommendation was to retain axilla/groin sampling as a core component while adding at least two further sites, but preferably more sites.
For healthcare institutions, the learning is practical: the performance of a screening pathway depends on what is sampled as well as how it is tested.
The timing of detection was another important point. In a follow-up group from the prospective study, 12 of 25 patients became culture-positive on repeat testing at day 7 or day 21. All 12 had already been PCR-positive at admission. This demonstrates how molecular testing can identify colonisation before it is demonstrated by subsequent culture, providing earlier information for infection prevention decisions. Eelco’s proposed approach for non-endemic settings combined validated PCR and sufficient sampling with subsequent enrichment culture. The methods contribute different information within a coordinated diagnostic pathway.
For countries where C. auris is not yet widespread, the experience of institutions facing established transmission offers an opportunity to prepare screening and infection prevention processes before outbreaks become harder to control.
Eelco also addressed an important question for endemic settings: if carriage is already common, does testing still add value? He highlighted associations between culture positivity, PCR cycle threshold values and fungaemia. These suggest that diagnostic findings may help distinguish clinically relevant differences within a population where colonisation is widespread. The possible role of Ct values in future policies remains an area for evaluation. These associations should not be treated as a validated method for predicting an individual patient’s outcome.
The broader message was that highprevalence should not lead to complacency. Instead, it changes the questionsthat a diagnostic strategy needs to answer.
The takeaway: effective C. auris screening brings together appropriate sampling, sensitive testing and a clear plan for interpreting and acting on the results.
Dennis van Tegelen explained how melt curve analysis can reveal more than whether a target is present. Following PCR amplification, a controlled melting step examines how DNA or probe–target combinations behave as temperature increases. Differences in sequence matching can produce distinguishable melting patterns. Those differences can help identify selected fungal species or resistance-associated genetic changes, adding information to a real-time PCR workflow.
Dennis demonstrated applications involving changes in the cyp51A gene associated with azole resistance in Aspergillus fumigatus, and the SQLE gene associated with terbinafine resistance in Trichophyton species. These examples showed how small genetic differences can provide clinically useful information. They also reinforced the importance of understanding how the result is generated. Dennis highlighted that low target levels and technical conditions can affect melt patterns, making careful interpretation essential.
The takeaway: melt curve analysis can provide additional species and resistance information, supported by an understanding of the method and its limitations.
Jochem Buil connected laboratory findings with the clinical consequences of waiting for an answer. His presentation showed why the timing of resistance information can be particularly important when the initial treatment may be ineffective.
One example compared two diagnostic pathways for the same illustrative patient with invasive aspergillosis. In the conventional pathway:
- Bronchoalveolar lavage was performed on day 0.
- Culture identified A. fumigatus on day 3.
- Susceptibility testing demonstrated resistance on day 8.
- The initial antifungal treatment was ineffective against the resistant infection.
In the molecular pathway, resistance information from the respiratory investigation supported effective treatment from day 1, seven days earlier. This was an illustrative comparison rather than a measured average reduction in treatment time. It made the potential clinical value of earlier resistance information clear.
Jochem supported the discussion with published evidence on the consequences of delayed effective treatment. In a study of 70 patients with haematological malignancy and mucormycosis,12-week mortality was approximately:
- 49% when effective amphotericin B-based treatment started within five days of diagnosis.
- 83% when treatment started six or more days after diagnosis.
These findings demonstrate the clinical stakes of obtaining actionable information promptly. They support the importance of timely diagnosis and effective treatment, while representing an association from an observational study rather than a measured mortality benefit from PCR itself. The opportunity for molecular diagnostics is to help shorten the interval between investigation and an informed treatment decision.
Jochem also highlighted a finding that adds an important dimension to the discussion of sensitivity. In the AzoRMan data he presented, six-week mortality was:
- 15% in patients with an isolated positive bronchoalveolar lavage PCR.
- 30% in GM-positive patients.
- 16% in patients with all tests negative.
GM refers to galactomannan, an antigen marker used in the investigation of aspergillosis. The isolated PCR-positive group had no excess mortality compared with the all-negative group. These were different diagnostic-result groups; the comparison does not demonstrate that PCR halved mortality.
Instead, it highlights the need to interpret additional molecular detections appropriately. A positive PCR result must be considered alongside the patient’s risk factors, imaging and other mycological findings.
The takeaway: molecular diagnostics can support earlier effective treatment, while informed interpretation helps determine what the result means for the individual patient.
Ferry Hagen closed the presentation programme by considering how fungal diagnostics may evolve. His outlook began with the changing challenge itself. Alongside established risk groups, patients receiving immunomodulatory treatments may become vulnerable to fungal infections. Emerging pathogens and antifungal resistance add further demands on diagnostic laboratories.
Ferry explored developments across antigen-based testing, isothermal amplification, broader molecular panels, imaging and AI-assisted identification. These approaches offer different ways of obtaining diagnostic information. Their usefulness will depend on the clinical question, the available evidence and the setting in which they are used. The presentation provided a broad view ofthe field, showing why laboratories need to understand both the capabilities and practical requirements of emerging methods.
Next-generation sequencing was an important part of Ferry’s outlook for fungal detection and identification. Sequencing can expand the genetic information available about fungi, but obtaining reliable results requires attention to the processes surrounding the technology. Ferry highlighted questions about sample extraction, enrichment, primer selection, quality control and reference databases. Each can influence the information obtained and how confidently it can be interpreted.
The takeaway: expanding technical capability needs to be matched by dependable workflows and interpretation if it is to provide useful diagnostic information.
Across the programme, each presentation examined a different part of the same challenge. Antoinette showed the evidence and continued oversight behind a diagnostic. Eelco demonstrated how sampling and testing inform infection prevention. Dennis explained how additional information can be extracted from a PCR workflow. Jochem connected earlier results with treatment decisions, while Ferry considered how laboratories may address future demands. The closing panel gave attendees an opportunity to explore these connections with the speakers. Over lunch, conversations continued in a more informal setting, with plenty of smiles and opportunities to compare experiences.
Thank you to Antoinette Brink, Eelco Meijer, Dennis van Tegelen, Jochem Buil and Ferry Hagen for sharing their expertise, and to everyone who joined the discussion. We also thank the Basecamp Utrecht team for helping make the day run smoothly.
We hope this first symposium will become a regular opportunity to share knowledge, discuss practical challenges and explore how fungal diagnostics can make a difference.
Published on:
November 5, 2026