Delphine Sepsis Diagnostic Test Kit - Delphine Diagnostics Inc.

Delphine Sepsis Diagnostic Assay

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.

Where are we now?

As an initial 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 (Table 1). Our PCR assay with these 11 bacterial targets will undergo five main phases of initial testing, which are estimated to be completed by December 2024.

Where are we going?

While Delphine’s Sepsis Diagnostic Assay’s Proof of Concept includes 11 bacterial targets, we plan to subsequently expand our panel to include resistance markers as well as other pathogens (e.g., additional bacteria, viruses, fungi, and parasites) to constitute a comprehensive sepsis diagnostic.

Relative to the gold standard of blood culture, Delphine’s Sepsis Diagnostic Assay aims to:

Have a faster turnaround time (results within hours as opposed to days)
Have a higher sensitivity for specific pathogens (able to detect lower amounts of common sepsis-causing microbes, including those that are difficult to culture

Unlike our competitors, Delphine’s Sepsis Diagnostic Assay aims to:

Be usable with standard equipment already present in a clinical lab, thus reducing the cost

We need you!

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 our future customers as to what attributes they are looking for in a diagnostic product! Specifically for Delphine’s Sepsis Diagnostic Assay, we would like to verify the User Needs with respect to our included targets (e.g., Staphylococcus aureus) and compatible equipment (i.e., specific nucleic acid extraction methods and PCR instruments) as well as to explore the future addition of host-based biomarkers. If you are interested in partnering with us in any of these endeavors, please contact us!

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 100 deaths annually in the United States [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, according to the CDC [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 in 2017 [6],[7].
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].