Antimicrobial resistance (AMR) remains a major global healthcare challenge, undermining the effectiveness of treatments for common infections and threatening modern medical advances. Improved antimicrobial stewardship (AMS) is essential to ensure antimicrobials are used appropriately.
Molecular diagnostics (MDx) can play a key role in stewardship by providing clinicians with rapid, actionable results that can support targeted therapy, reduce unnecessary antimicrobial use and improve patient outcomes.
Technology Networks recently spoke with Dr. Denise Heaney, chief medical partner for molecular solutions and infectious disease at Roche Diagnostics, to explore how MDx are reshaping AMS and redefining the standard of care for infectious diseases.
Anna MacDonald (AM):
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
Why is AMS critical in today’s healthcare environment beyond just addressing AMR?
Denise Heaney, PhD (DH):
Chief Medical Partner, Molecular Solutions and Infectious Disease
Roche
Dr. Denise Heaney is senior scientific affairs manager in medical and scientific affairs at Roche Diagnostics, supporting the Diagnostics Information Solutions (DIS) division. In this role, she leads and supports investigator-initiated and Roche-sponsored studies, scientific communications and the execution of medical plans for DIS applications.
AMS is fundamentally critical in today’s healthcare environment, extending its value far beyond the necessary goal of combating AMR to function as a core driver of operational efficiency and system performance. Stewardship efforts, underpinned by diagnostic precision, can address the substantial economic burdens associated with unnecessary care.
We now have advances in technology that enable clinicians to obtain more information than they previously had. Because some respiratory symptoms are so similar, relying on empirical observations alone makes it difficult to make the right treatment choices, and this frequently leads to the overuse of broad-spectrum antibiotics, which can result in unnecessary costs and inefficient resource utilization across the health system.
Implementing effective AMS, particularly enhanced by rapid molecular point-of-care (POC) testing, has been shown to generate measurable institutional cost savings by decreasing auxiliary testing, reducing hospital admissions and decreasing hospital length of stay. Ultimately, achieving appropriate antibiotic use is essential for realizing cost and resource efficiency, streamlining clinical workflows and enhancing the overall efficiency of healthcare systems.
From a quality-of-care perspective, antibiotic stewardship is vital for patient safety and preventing avoidable negative health outcomes. The widespread issue of unnecessary antibiotic prescribing – estimated to occur in nearly one-third of outpatient prescriptions – exposes individuals to avoidable side effects associated with these drugs.
Research has demonstrated connections between early childhood antibiotic exposure (especially repeat prescriptions) and an increased risk of long-term health issues, including early-onset asthma, celiac disease, metabolic conditions and attention deficit hyperactivity disorder.
By enabling rapid and precise differentiation between viral and bacterial infections, diagnostics allow clinicians to make evidence-based decisions, ensuring that patients receive targeted treatments only when necessary and preventing exposure to broad-spectrum agents that disrupt the human microbiota. This diagnostic certainty also aids clinicians in communicating clear, evidence-based treatment plans to patients, reinforcing compliance and addressing uncertainty when antibiotics are not appropriate.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
How are MDx reshaping the way clinicians approach antibiotic stewardship?
DH:
Chief Medical Partner, Molecular Solutions and Infectious Disease
Roche
Dr. Denise Heaney is senior scientific affairs manager in medical and scientific affairs at Roche Diagnostics, supporting the Diagnostics Information Solutions (DIS) division. In this role, she leads and supports investigator-initiated and Roche-sponsored studies, scientific communications and the execution of medical plans for DIS applications.
MDx are fundamentally reshaping AMS by leveraging PCR-based precision and speed to eliminate clinical uncertainty, directly challenging the cycle of unnecessary and broad-spectrum antibiotic prescribing.
Advanced MDx, particularly POC testing, brings lab-quality results closer to the patient, such as with the cobas® liat system, often within 15–20 minutes, enabling evidence-based treatment decisions during a single patient visit.
These rapid diagnostics reliably differentiate between viral and bacterial pathogens, overcoming the low sensitivity of symptom-based diagnoses.
Innovations such as customizable multiplex panels and “digital reflex testing” optimize diagnostic stewardship by allowing clinicians to order only the necessary targets initially, thereby reducing duplicate testing, lowering reagent costs and focusing therapy on the specific pathogen detected.
This ability to ensure the right drug, dosage and duration is prescribed helps preserve the efficacy of existing narrow-spectrum antimicrobials, which is critical in combating the global threat of antimicrobial resistance.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
How can multiplex testing help clinicians quickly differentiate bacterial from viral infections, and what impact does this have on patient care?
DH:
Chief Medical Partner, Molecular Solutions and Infectious Disease
Roche
Dr. Denise Heaney is senior scientific affairs manager in medical and scientific affairs at Roche Diagnostics, supporting the Diagnostics Information Solutions (DIS) division. In this role, she leads and supports investigator-initiated and Roche-sponsored studies, scientific communications and the execution of medical plans for DIS applications.
Multiplex molecular testing fundamentally aids clinicians in the rapid differentiation of bacteria from viral infections by simultaneously detecting and differentiating multiple pathogens that present with similar or overlapping symptoms from a single patient sample, often using highly sensitive PCR technology.
This “syndromic approach” is particularly critical during peak seasons when illnesses such as influenza, respiratory syncytial virus and SARS-CoV-2 (viral pathogens) co-circulate with bacterial threats like Mycoplasma pneumoniae or Bordetella pertussis, causing symptoms like cough and fever.
These targeted MDx provide results with high specificity and sensitivity, such as the over 98% accuracy seen with rapid PCR testing for influenza, compared to clinical symptom diagnosis, which can be as low as 36% sensitive.
When deployed using in-patient testing or POC testing platforms, these assays can deliver definitive results in as little as 90 minutes for inpatient and 15–20 minutes for POC, eliminating the clinical uncertainty that typically leads to inappropriate or broad-spectrum antibiotic prescribing.
The impact of this rapid and accurate differentiation on patient care is substantial, primarily through enhanced AMS and optimized treatment protocols. By definitively confirming a viral cause, multiplex testing prevents the unnecessary administration of antibiotics, a major contributor to AMR.
Conversely, if a bacterial infection is identified quickly, clinicians can initiate appropriate, narrow-spectrum antibiotic therapy earlier, reducing the risk of complications and minimizing exposure to broad-spectrum agents that disrupt the human microbiota.
Furthermore, rapid results facilitate timely antiviral treatment, which has narrow windows of effectiveness for viruses like SARS-CoV-2 and influenza. Studies confirm that rapid molecular POC testing for respiratory viruses contributes to appropriate changes in antimicrobial treatment plans for a significant percentage of patients, while also supporting public health efforts by enabling faster infection control and isolation strategies.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
What are the key barriers that limit the adoption of MDx, and how can health systems work to overcome them?
DH:
Chief Medical Partner, Molecular Solutions and Infectious Disease
Roche
Dr. Denise Heaney is senior scientific affairs manager in medical and scientific affairs at Roche Diagnostics, supporting the Diagnostics Information Solutions (DIS) division. In this role, she leads and supports investigator-initiated and Roche-sponsored studies, scientific communications and the execution of medical plans for DIS applications.
The adoption of MDx, particularly in POC testing, is often hampered by significant logistical and human capital barriers, despite the technological maturity of PCR-based platforms. A primary limitation is the persistent shortage of adequately trained personnel to operate and maintain these systems efficiently.
Advanced molecular technologies are now reaching Clinical Laboratory Improvement Amendments (CLIA) waived status. We now need to reconsider how and where we use them. User-friendly, CLIA-waived benchtop solutions designed to overcome infrastructure constraints can be successfully implemented in decentralized settings without needing an operator with lab training. However, the false perception is that they still need to be operated by laboratory-trained professionals.
Health systems must also manage the intrinsic complexity of diverse diagnostic options, contending with issues related to workflow integration, inventory management, quality assurance and aligning testing algorithms with institutional goals.
Furthermore, reimbursement policies often fail to fully reflect the documented value of POC testing in improving patient outcomes and streamlining workflows, presenting a financial obstacle that necessitates generating strong real-world evidence to justify adoption.
Health systems can mitigate these adoption barriers through strategic investment and the implementation of sophisticated diagnostic stewardship programs. Overcoming infrastructure challenges requires investing in resilient, flexible molecular solutions that can be easily integrated into existing workflows in decentralized settings.
Modern MDx platforms offer customizable multiplex panels, which enable providers to design tests that detect only medically necessary targets based on patient demographics and regional pathogen prevalence, and maximizing diagnostic yield.
Crucially, adopting features like “digital reflex testing” helps streamline diagnostic processes; if initial, targeted results (e.g., respiratory 4-plex) are negative, the instrument can automatically provide results for additional pathogens from the same run, which supports stewardship by reducing duplicate testing and decreasing reagent costs.
Finally, gaining organizational buy-in requires tracking key performance indicators, such as cost avoidance per patient, treatment accuracy rate and test utilization rate, to demonstrate the clear operational and economic impact of MDx to administrators and payers.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
Which emerging technologies have the greatest potential to transform AMS over the next decade?
DH:
Chief Medical Partner, Molecular Solutions and Infectious Disease
Roche
Dr. Denise Heaney is senior scientific affairs manager in medical and scientific affairs at Roche Diagnostics, supporting the Diagnostics Information Solutions (DIS) division. In this role, she leads and supports investigator-initiated and Roche-sponsored studies, scientific communications and the execution of medical plans for DIS applications.
The next decade of AMS transformation will be defined by the convergence of advanced MDx with sophisticated data systems and extreme miniaturization. A primary driver will be the widespread adoption of flexible, customizable molecular solutions on both high-throughput laboratory and POC platforms.
Innovations like Roche’s Temperature-Activated Generation of Signal technology are enabling expanded multiplex PCR testing by allowing the detection and differentiation of multiple targets within a single optical channel. This technological foundation supports features crucial for AMS, such as “digital reflex testing”. Companies will also be focused on rolling out ultra-fast PCR platforms capable of delivering definitive results in as little as 5–10 minutes.
The diagnostics market is rapidly shifting toward syndromic infectious disease panels that directly incorporate the detection of AMR markers, providing clinicians with immediate, actionable data on drug susceptibility. This will profoundly reshape treatment strategies and preserve existing narrow-spectrum antibiotics. Beyond hardware and assay innovation, advanced computing and engineering technologies have immense potential to transform the field of AMS.
Over the next 5–10 years, artificial intelligence and machine learning are poised to revolutionize diagnostics by enabling more effective analysis of complex data, enhancing diagnostic accuracy, predicting outbreaks and optimizing antimicrobial treatment strategies through data-driven insights and clinical decision support.
Additionally, the expansion of testing into highly decentralized settings will be powered by miniaturized technologies, such as wearable diagnostics, microfluidics, lab-on-a-chip platforms and cutting-edge biosensors.
Molecular POC technologies are expected to expand their utility beyond respiratory diseases to address a broader range of infectious diseases, including sexually transmitted infections, enabling rapid test-to-treat models and enhancing care coordination through seamless data sharing with electronic health records.
The introduction to this interview includes text that has been created with the assistance of generative AI and has undergone editorial review before publishing. Technology Networks' AI policy can be found here.