Delphine Sepsis Diagnostic Assay

A concept-stage real-time PCR assay designed to detect microbial pathogens and resistance markers directly from whole blood specimens of patients with suspected sepsis.

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Development status Concept and proof-of-concept development
Delphine molecular diagnostic assay kit concept

Move from culture-dependent delay toward molecular insight.

Delphine is currently in the Concept Phase of the Product Development Process for its Sepsis Diagnostic Assay, a real-time polymerase chain reaction (PCR) test to detect the presence of microbial pathogens and resistance markers directly from whole blood specimens of patients with suspected sepsis.

Conventional blood culture can take days to identify a pathogen and inform antimicrobial susceptibility. During that uncertainty, clinicians must make urgent treatment decisions for patients whose condition can deteriorate rapidly.

Delphine's assay concept uses real-time polymerase chain reaction to look directly for microbial DNA in whole blood. The intended design aims to support earlier pathogen identification and, as the panel expands, resistance-marker insight.

01

Direct from whole blood

Designed to detect microbial targets without waiting for a positive blood culture.

02

Results within hours

Aims for a faster turnaround than conventional workflows that may require multiple days.

03

Higher target sensitivity

Intended to detect lower quantities of selected sepsis-causing microbes, including difficult-to-culture organisms.

04

Standard lab equipment

Planned for compatibility with equipment already found in clinical laboratories to help control cost.

A structured proof of concept to demonstrate technical feasibility.

Delphine is currently designing and validating primer sets for 11 bacterial pathogens commonly implicated in human infection in the United States. The PCR assay with these targets will undergo five main phases of initial testing, estimated to be completed by December 2024.

Five assay development phases from in-silico inclusivity through mock-sample testing
Development phases described by Delphine: in-silico inclusivity and exclusivity, in-vitro inclusivity and exclusivity, limit of detection, and mock-sample testing.

Eleven bacterial proof-of-concept targets.

The initial target set represents clinically important organisms associated with bloodstream infection, invasive disease, healthcare-associated infection, or antimicrobial resistance.

01

Staphylococcus aureus

Major cause of bloodstream infection and invasive disease.

02

Escherichia coli

Common cause of urinary, gastrointestinal, and bloodstream infections.

03

Klebsiella pneumoniae

Important healthcare-associated pathogen with resistance concerns.

04

Pseudomonas aeruginosa

Opportunistic pathogen associated with severe and drug-resistant infection.

05

Enterococcus faecalis

Associated with bloodstream, urinary tract, and healthcare-related infections.

06

Streptococcus pneumoniae

Cause of pneumonia, meningitis, and invasive pneumococcal disease.

07

Staphylococcus epidermidis

Frequently associated with devices and healthcare-related bloodstream infection.

08

Streptococcus agalactiae

Cause of severe infection, particularly in newborns and vulnerable adults.

09

Streptococcus pyogenes

Associated with invasive group A streptococcal disease.

10

Acinetobacter baumannii

Healthcare-associated organism known for multidrug resistance.

11

Haemophilus influenzae

Cause of invasive respiratory and bloodstream infection.

Table 1. The Eleven Bacterial Targets Included in Delphine's Proof of Concept
Organism Justification
Staphylococcus aureus The CDC has reported that, in 2017, more than 119,000 people in the United States had bloodstream S. aureus infections and nearly 20,000 of them died [1].
Escherichia coli According to the North Carolina Department of Health and Human Services, E. coli infections cause an estimated 265,000 illnesses and about 30 deaths in the United States each year [2].
Klebsiella pneumoniae Statistics from Tufts University School of Medicine suggest that there were over 73,000 nosocomial K. pneumoniae infections and 4,800 related deaths in the United States in 2011 [3].
Pseudomonas aeruginosa In 2017, multidrug-resistant P. aeruginosa caused approximately 32,600 infections in hospitalized patients in the United States and 2,700 deaths [4].
Enterococcus faecalis Data suggests that E. faecalis is responsible for approximately 140,000 infections in the United States each year [5], and it is plausible that E. faecalis may have resulted in more than 2,000 deaths in the United States.
Streptococcus pneumoniae According to the CDC, S. pneumoniae causes over 2 million infections, 150,000 hospitalizations, and 6,000 deaths annually in the United States [8].
Staphylococcus epidermidis Data suggests that annually in the United States there are over 55,000 bloodstream infections [9], [10] and 1,500 deaths [9], [11] related to S. epidermidis.
Streptococcus agalactiae In 2016, there were about 31,000 severe S. agalactiae infections in the United States, 1,700 of which resulted in death, according to the CDC [12].
Streptococcus pyogenes The CDC has reported that S. pyogenes causes more than 12,500 invasive infections and 1,250 deaths in the United States each year [13].
Acinetobacter baumannii Data suggests that there were likely around 13,000 A. baumannii infections in the United States in 2017 and more than 700 deaths [14], [15], [16].
Haemophilus influenzae According to the CDC, there were an estimated 7,550 cases of invasive H. influenzae infection and 910 related deaths in the United States in 2017 [17].

Toward a broader, more comprehensive sepsis diagnostic.

While the proof of concept includes 11 bacterial targets, Delphine plans to subsequently expand the panel to include resistance markers as well as other pathogens, including additional bacteria, viruses, fungi, and parasites.

BacteriaAdditional clinically relevant bacterial targets
ResistanceMarkers associated with antimicrobial resistance
VirusesViral targets relevant to severe systemic infection
Fungi & parasitesBroader microbial coverage for complex cases
Host responseFuture exploration of host-based biomarkers

Help shape the assay around real user needs.

Delphine is passionate in its efforts to deliver best-in-class products to speed effective diagnosis for patients with infectious diseases. We are always interested in hearing from future customers about the attributes they are looking for in a diagnostic product, including included targets, compatible equipment, nucleic-acid extraction methods, PCR instruments, and future host-based biomarkers.

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Sources for proof-of-concept target justifications.

  1. CDC: Deadly staph infections
  2. North Carolina DHHS: E. coli infection
  3. Microbiology and Molecular Biology Reviews
  4. CDC: Pseudomonas aeruginosa in healthcare settings
  5. Enterococcal infections reference
  6. CDC: Vancomycin-resistant Enterococci
  7. Clinical Infectious Diseases reference
  8. CDC: Streptococcus pneumoniae threat report
  9. Annals of Medicine reference
  10. Nature Reviews Microbiology reference
  11. Seminars in Immunopathology reference
  12. CDC: Group B Streptococcus threat report
  13. CDC: Group A Streptococcus threat report
  14. CDC: Acinetobacter in healthcare settings
  15. CDC AR Patient Safety Portal: Carbapenem-resistant Acinetobacter
  16. PLOS ONE reference
  17. CDC ABCs bacterial facts dashboard
Development-stage product

The Delphine Sepsis Diagnostic Assay is described as a concept/proof-of-concept product and is not presented here as commercially available or cleared for clinical use.