Antimicrobial resistance

Although new antibiotics are being developed, widespread, unregulated, and inappropriate use of pharmaceuticals has led to growing rates of drug resistance, impacting our ability to treat common infections.³ Antimicrobial resistance (AMR) affects countries in all regions of the world, and at all income levels, resulting in huge numbers of avoidable deaths every year. Bacterial AMR was estimated to be directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths. In addition to death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in US $1 trillion in additional healthcare costs by 2050.³

The rise of infections like methicillin-resistant Staphylococcus aureus (MRSA) and sepsis places a considerable burden on healthcare systems:

Methicillin-resistant Staphylococcus aureus (MRSA)

MRSA is a bacterial infection that causes the same infection as Staphylococcus aureus (SA), however, it is dangerous due to its resistance to many antibiotics that successfully treat normal SA.⁴ Hospitalized patients endure prolonged stays, resulting in tangible and intangible costs that add to the considerable price tags associated with the increased morbidity and mortality rates due to MRSA/SA infections. In the US alone, SA and MRSA infections burden the healthcare system with approximately $9.5 billion and $20 billion in annual care costs, respectively.^5,6

Sepsis

Sepsis is one of the most significant health complications linked to antimicrobial resistance, responsible for approximately 20% of deaths worldwide.⁷ The growing resistance of germs to antimicrobial medicines significantly increases the risk of sepsis, particularly in infections caused by drug-resistant bacteria and fungi.^3,8 Notably, fungal infections are associated with even higher mortality rates.⁹

There are also a growing number of infectious diseases developing resistance to common treatments, including tuberculosis, HIV, and malaria.³ In the absence of a comprehensive effort to combat emerging drug resistance, infections due to multi-drug-resistant organisms are predicted to be responsible for 10 million deaths worldwide per year by 2050.¹⁰

Diagnoses based on signs and symptoms alone cannot reliably differentiate bacterial agents, nor discriminate between bacteria, viruses, and fungi. The inability to accurately diagnose the exact pathogen causing an infection often leads to broad-spectrum or inappropriate antibiotic prescribing.¹¹ Eliminating inappropriate use of antibiotics is essential for preventing the emergence of drug-resistant bacteria. A key strategy to countering this issue, and enabling antibacterial stewardship, is the consistent and proper use of diagnostic tests.¹²

However, access to reliable clinical diagnostic or microbiologic testing can be a limiting factor.¹³ In addition, traditional ‘culture’ method diagnostic solutions require access to highly trained technicians to ensure quality standards. The technique also requires time for the organism to grow resulting in a long turnaround time with consequent delay in providing appropriate targeted treatment.

Recent advances in testing are accelerating the way resistant pathogens are detected compared to traditional methods, however, adoption of rapid diagnostics for routine clinical laboratory use remains a challenge due to resource limitations and the perception of costly upfront investment.¹²

Since PCR was invented in the early 1980s, Roche has been at the cutting edge of developing new detection technologies to simplify and automate molecular testing. PCR technology detects life-threatening pathogens at the earliest stages of infection by direct detection of viral RNA or DNA. Early detection allows clinicians to provide rapid intervention that can be lifesaving in critical situations, reducing complications, and improving recovery times. Our solutions include:

• The cobas® eplex system to fully automate syndromic molecular testing, including sample preparation, extraction, amplification, and detection to deliver rapid, sample-to-answer results on every shift.
• The cobas® MTB and cobas® MTB-RIF/INH tests to detect Mycobacterium tuberculosis complex (MTBC) and drug resistance (rifampicin [RIF] and isoniazid [INH]), respectively in tuberculosis.^15,16 The tests are for use on the cobas® 5800/6800/8800 systems which automatically extract DNA for real-time PCR.
• The cobas® MRSA/SA Test on the cobas® 4800 System which is an automated, real-time PCR assay for the rapid in vitro qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings.^17,18
• The cobas® eplex blood culture identification panels (BCID) can detect approximately 95% of bloodstream infections, including sepsis-causing bacteria and fungi, enabling early diagnosis and intervention.^19,20,21 This comprehensive approach improves detection of infectious diseases, such as sepsis, that are often challenging to diagnose with conventional methods.

Recent advances in testing are accelerating the way resistant pathogens are detected compared to traditional methods. However, this is not a battle that will be won in the laboratory alone. Each year, there are millions of unnecessary antibiotic prescriptions written in doctors’ offices and emergency departments. For example, of the 40 million antibiotic prescriptions for respiratory issues in the US every year, 27 million are unnecessary, highlighting the need for advanced point-of-care testing solutions.²¹

Point-of-care testing solutions using PCR technology are changing the healthcare paradigm. Medical staff can take a swab from a patient’s throat and use a compact device to get highly accurate results quickly. Clear diagnostic information enables healthcare providers to prescribe more judiciously and employ antibiotic stewardship principles so they only prescribe antimicrobials when needed.

Our cobas® liat 4-plex test received FDA emergency use authorization* in June 2024 and has proven effective in promoting responsible antibiotic use in studies across various healthcare settings.²²

• In the emergency department, Hansen et al (2018) found that using the cobas® liat for influenza testing led to a 24.5% reduction in inappropriate antibiotic use, while May et al (2023) reported a 20.2% reduction in antibiotic prescriptions for SARS-CoV-2 positive patients when using the cobas® liat assay^23,24
• In primary care, May et al (2022) showed that implementation of the cobas® liat Strep A assay reduced antibiotic prescribing by 44% for patients who tested negative²⁵
• The system can also be used in “non-traditional” patient care settings. Klepser et al. (2019) evaluated the effect of the cobas® liat assays for influenza and Group A streptococcal (GAS) pharyngitis in a community pharmacy where they found that no patients who tested positive for influenza received antibiotics.²⁶