“Diagnostics are the single biggest potential game changer in the fight against AMR”

Lord Jim O’Neill

The time delay in starting appropriate antibiotic treatment and patient care is a matter of life or death for serious infections such as sepsis, pneumonia and meningitis. This has been complicated by the fact that the number of patients with multi-drug resistant bacterial infections, for whom there are only very limited therapeutic options, is constantly rising worldwide.

The microbiology laboratory therefore plays a crucial role in identifying the infectious agent, as well as any potential resistance to antibiotics, in order to help clinicians prescribe the most appropriate treatment with the shortest time delay.

These diagnostic tools help to:

  • identify patients who have a bacterial infection which would require antibiotic treatment,
  • identify the organism causing the infection in order to determine the appropriate patient management,
  • determine whether the pathogen is resistant to one or more antibiotics as a critical step to help the clinician prescribe the most appropriate antibiotics as early as possible.

Once resistant bacterial strains have emerged, diagnostics also play a key role in limiting their spread. They enable screening for the presence or absence of a resistant pathogen, so that patient isolation or other infection control measures can be taken to avoid or limit their spread.

Interaction between diagnostic and antimicrobial stewardship

Diagnostic stewardship refers to the appropriate use of laboratory testing to guide patient management, including treatment, in order to optimize clinical outcomes and limit the spread of antimicrobial resistance. This requires a seamless partnership between clinical laboratories, pharmacists, and infectious diseases clinicians, so that appropriate tests are ordered and diagnostic information is translated into appropriate management in real time.

Role of Diagnostics in Stewardship for AMR

DIAGNOSTICS AND DRUG CLINICAL TRIAL OPTIMIZATION

The bioMérieux Companion Diagnostics program offers tailored and complete partnerships with pharmaceutical companies, which includes:

  • implementing a supportive/complementary diagnostic approach during the clinical trials of a novel antibiotic by rapidly identifying the optimal patient population and pathogens, leading to an increased probability of trial success, as well as time-savings and cost-effectiveness for pharmaceutical companies,
    > Learn more about the role of Diagnostics in Clinical Trial Enrollment Optimization: Four diagnostic strategies for better-targeted antibiotic use, 2016, WellcomeAct
  • developing a “companion diagnostics” solution that could be used during antibiotic commercialization to ensure the most appropriate choice of antibiotic in a given context (i.e. “Personalized/Precision Medicine”). In this context, bioMérieux works in ever-closer cooperation with pharmaceutical companies to develop susceptibility tests to accompany the launch of new antibiotics on the market.

> Find out more about bioMérieux’s Companion Diagnostic solution for Personalized/Precision medicine

COLLABORATION WITH ENTASIS THERAPEUTICS TO OPTIMIZE PHASE 3 ENROLLMENT FOR NEW ANTIBIOTIC



New pathogen-targeted agent:
SULBACTAM DURLOBACTAM (ETX2514SUL)

Indication:
Multidrug-resistant Acinetobacter infections

As part of an agreement with Entasis Therapeutics, a US-based biopharmaceutical company, bioMérieux is providing BIOFIRE® FILMARRAY® systems and BIOFIRE® FILMARRAY® Pneumonia panels to support patient enrollment optimization in a Global Phase 3 trial of a new antibacterial agent developed by Entasis.

This new pathogen-targeted agent, Sulbactam Durlobactam (ETX2514SUL), is intended for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii.

Entasis aims to optimize clinical trial enrollment through patient cohort enrichment by using therapid molecular diagnostic platform BIOFIRE® FILMARRAY® (2.0) to identify A. baumannii in 1 hour. The diagnostic result will support more effective randomization of patients with respiratory symptoms who are infected by A. baumannii and who may benefit from the antibiotic Sulbactam Durlobactam (ETX2514SUL). Additional benefits of optimized enrollment may include a more decisive clinical data set for drug efficacy and safety profile assessments, reduced timelines for study completion, and clinical trial cost-effectiveness.

A. baumannii, a Gram-negative bacterium causing severe infections, is associated with high mortality, rapidly-increasing rates of antibiotic resistance, growing significance as a hospital-acquired infection, and limited treatment options. It is on the WHO list of antibiotic-resistant “priority pathogens” due to its multidrug resistance that poses a particular threat in hospitals, nursing homes, and among patients whose care requires devices such as ventilators and blood catheters.