IVD Responds to Sepsis with Rapid Testing Solutions

IVD Responds to Sepsis with Rapid Testing Solutions

Sepsis is a serious condition, but one where the development of testing technologies has assisted outcomes.   Sepsis is a potentially lethal condition in which the immune system mounts an overactive, toxic response to an infection, and ends up turning instead on the host body. It is a potential complication of infection, as chemicals released in the body from the immune response can lead to tissue damage and organ failure, and ultimately, to death. The condition progresses in three stages:

  • Early stage sepsis, in which, during the course of a confirmed or suspected infection, the patient experiences two symptoms of systemic inflammatory response syndrome (SIRS), which includes temperature above 101°F or below 96.8°F, tachycardia (over 90bpm), a respiratory rate of over 20 breaths per minute, abnormal leukocyte count, and/or abnormal blood gas (PaCO2 under 32mmHg)
  • Severe sepsis, which adds at least one of the following symptoms – decreased urinary output, change in mental status, decrease in platelet count, difficulty breathing, abnormal heart pumping action, or abdominal pain
  • Septic shock is severe sepsis with extreme hypotension that does not respond to treatment with intravenous fluids

 Sepsis can be caused by any infection, but it results primarily from pneumonia or from abdominal, kidney, or bloodstream infection. Staphylococcus aureus, Escherichia coli, and some Streptococcus bacteria species, among others, are commonly associated with sepsis. Age, drug resistance, and weakened immune systems increase risk. People most susceptible are, as usual, very young or very old, living with chronic illness, or have compromised immune systems. Sepsis often occurs in hospitals, especially with patients who are injured (e.g. burns) and/or have devices inserted in them like catheters or breathing tubes. Complications arise with the severity of the condition, as blood flow becomes impaired, and clots can form in the organs and extremities, and risk for gangrene and organ failure increases.

 Mild sepsis is treatable with antibiotics and methods to maintain oxygen and circulation, but with severity comes greater risk, and septic shock carries with it a 50% mortality rate, and severe sepsis leaves patients open for future infections. And then, 50% of patients experience post-sepsis syndrome, which not affects survivors physically (fatigue, muscle and joint pains), but it also carries a host of psychological issues, including insomnia, nightmares and hallucinations, panic, cognitive deficits, and decreased self esteem. Many of the physical symptoms can be attributed to the gangrene and organ damage that comes with severe sepsis, but the psychological symptoms are a mystery.

 A major problem with sepsis is that many of its features – fever, respiratory and circulatory issues – are commonly associated with other conditions, so diagnosing it can be difficult in early stages, when it can be most easily treated. However, a number of biotech companies – profiled in our upcoming Molecular Point-of-Care Diagnostics report – have placed some of their focus on solutions for sepsis diagnosis:

  • A number of cartridges in development for the io system by Atlas Genetics are dedicated to hospital-associated infections, including MRSA/SA, C. difficile, and norovirus, and Atlas is also working on a multiplex sepsis identification cartridge
  • Biocartis has been in a collaborative partnership with Microbiome since 2015 to develop and license a multiplex qPCR assay for the rapid detection of bloodstream infections; the assay itself would be developed by the latter for use on the former’s Idylla platform, which has been tested as part of the largest sepsis study in Europe
  • One of the FDA-approved multiplex assays for bioMérieux’s BioFire FilmArray system is the blood culture identification (BCID) panel, with a host of sepsis-related targets including aureus, Candida, Enterococcus, and Pseudomonas aeruginosa, along with methicillin, vancomycin, and carbapenem resistance genes
  • Available for Curetis’ Unyvero platform is the BCU Infection cartridge, which detects up to 103 analytes, covering pathogens associated with bloodstream infections and sepsis, as well as for resistance biomarkers; the German company is also in collaboration with Acumen Research Laboratories of Singapore on the development of a Sepsis Host Response cartridge for the Unyvero, which will detect changes in patients’ immune systems indicative of bloodstream infection and SIRS
  • Among the first DNA Electronics assays for the LiDiA system, anticipated to launch in 2018, is a test panel designed to detect critical bacterial and fungal pathogens associated with the bloodstream infections that often lead to sepsis, without the need for blood culture, in an actionable three hours
  • GeneFluidics was awarded a $3.5 million grant from the National Institute of Allergy and Infectious Diseases to develop and validate tests detecting bloodstream infection or sepsis, identifying pathogens, and recognizing antimicrobial susceptibility
  • The primary project by Seattle-based Immunexpress is SeptiCyte, an advanced sepsis diagnostic system that uses hundreds of nucleic acids and protein biomarkers in patient blood, reported to differentiate sepsis from non-septic systemic inflammation
  • Nanodetection Technology’s assay portfolio for the cassette-based NDT system includes solutions for nosocomial infections, including MRSA and sepsis itself
  • Nanōmix is working on eLab, their CNT-based system, with the company’s focus directed on a sepsis panel that produces actionable results from a blood, serum, or plasma sample, within 10 minutes; the panel detects three major biomarkers associated with sepsis: lactate enzymes, c-reactive protein, and procalcitonin
  • In development by Rheonix is a CARD-based sepsis assay for the EncompassMDx platform, detecting in three hours 150 pathogens from whole blood samples
  • Seegene offers a Magicplex sepsis qPCR panel, which detects over 90 pathogens from whole blood in three hours; the assay targets Gram-positive bacteria like Streptococcus, Enterococcus, and Staphylococcus species, Gram-negative bacteria like aeruginosa and Escherichia species, Candida fungal species, and vanA, vanB, and mecC drug resistance markers
  • The CLIA-moderate T2Candida and CE-marked T2Bacterial panels from T2 Biosystems detect sepsis-causative bacterial and fungal agents with the firms magnetic resonance-based diagnostic platform