SEPSIS

Every hour delay from effective treatment has a 9% drop in patient survival from sepsis shock

MASSIVE IMPACT ON LIFE AND HEALTHCARE

Sepsis kills more people than any other medical condition in the US and has a devastating  impact worldwide. Each year in the US sepsis causes 270,000 deaths, 1,700,000 cases, $24 B medical costs, $1.6 B litigation payments, 60% re-hospitalization within 12 months with a high incidence of permanent organ damage, cognitive impairment, and physical disability, and the possible progression to sepsis shock with a 50 – 85% mortality.

CULTURE-BASED SEPSIS PATHOGEN TESTS TAKE TOO LONG AND ARE ERROR-PRONE

Sepsis is detected from a patient sample using a 12 hour culture to reproduce bacteria and fungi, followed by subcultures taking 72 hours to identify specific pathogens and their drug resistance.

• Cultures can have up to 42% false negatives due to pathogens not replicating in the culture environment, the pathogen is injured at the time of testing and needs to rejuvenate before reproducing, or the pathogen is a virus and does not replicate in a culture. In these cases, the pathogen is not detected, treatment is delayed and patient survival drops.
• Cultures can also have a 30-50% false positive rate due to contaminants or non pathogenic materials that test positive. This results in patients unnecessarily receiving antibiotics and risking side effects such as C. difficule infections.
• Subcultures can indicate that up to 38 - 83% of sepsis pathogens are resistant to antimicrobials. If the effective treatment is delayed, then patient survival drops. Subculturing can be replaced with syndromic testing involving multiplex PCR in order to identify pathogens and resistance in 1 to 5 hours. Syndromic testing employs a 12 hour culture.

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OTHER TESTS DON'T DETERMINE DRUG RESISTANCE

Sepsis can be rapidly diagnosed by analytics and/or protein biomarkers such as Procalcitonin (PCT) and C-reactive protein (CRP). These tests have limited abilities to distinguish sepsis from other inflammatory conditions, to predict outcome, to identify the pathogen-causing the infection or to determine antibiotic resistance.

Guanine will revolutionize sepsis pathogen testing by eliminating the culture

Guanine's upcoming mobile sepsis test detects specific pathogens and drug resistance biomarkers in 45 minutes without a culture. This will greatly improve sepsis pathogen testing by:

• Reducing test time by hours or days
• Eliminating false outcomes caused by cultures
• Enabling mobile pathogen testing for ERs, ambulances, home and community care services, and the military
  

Guanine detects sepsis pathogens and drug resistance biomarkers by generating oxidation peaks from 4 different oligonucleotide tags (G,A,T.C) on 6 different electrodes. This allows difference sepsis targets to be detected from a single sample including bacteria, fungi, resistance biomakers and even viruses since a culture is not needed.

KPC RNA PERFORMANCE DATA

Klebsiella pneumoniae carbapenemases (KPCs) RNA from KPC producing Klebsiella pneumoniae and Escherichia coli bacteria are detected in 45 minutes without an overnight culture.

Rapid and accurate hybridization from 70 sequences that are not restricted by PCR’s 20 sequence limitation

Guanine’s assay produced a positive signal in 22/22 samples containing KPC-producing K.pneumoniae and a negative signal in 5/6 non KPC-producing K.pneumoniae samples

Positive signal peaks are
much higher for targets
bound by millions of electrical tags