Posts Tagged antibiotic resistance

Speedy identification of pathogens: saves lives, reduces cost & lowers antibiotic resistance problem


At a recent Bio2DeviceGroup (www.bio2devicegroup.org) event, Kevin Hacker, CEO of BioAffinity Sciences talked about their new technology that when fully developed will identify pathogens more than 100 times faster than the traditional blood culture and related technologies currently in use.

Sepsis Problem

Sepsis, bacteria in blood. 3D illustration showing rod-shaped bacteria with red blood cells and leukocytes

Every year, in the US, 500 thousand people die due to sepsis related complications. Sepsis is a final common pathway for many infections, particularly when an individual’s immunity is low. Body normally releases chemicals into the bloodstream to fight an infection. When the body’s response to these chemicals is out of balance, it results in Sepsis. That is when body’s immune system launches a massive counter attack that harms body’s own tissues and organs. The triggering changes begin to damage body’s vital organ systems that results in dramatic drop in the blood pressure, ultimately leading to death.

Sepsis and septic shock are more common if the individual is very young or very old, have a compromised immune system, have diabetes or cirrhosis, is already sick and frequently in a hospital intensive care unit, have wounds or injuries or severe burns, have invasive devices inserted into the body, and have previously received antibiotics or corticosteroids. Often people can recover from mild sepsis. However, if the body goes into septic shock, the average mortality rate for septic shock is about 40%. Additionally, an episode of severe sepsis may place a person at higher risk of future infections.

Given that widespread infections can progress to Sepsis and Sepsis shock in a matter of few hours, it is imperative that such infections be treated immediately with antibiotics. When given the right antibiotics, there is often a dramatic improvement and speed of cure.

Problem with speedy identification of pathogens

Petri dish with Escherichia Colli bacteria under the light of the laboratory microscope. Medical laboratory concept

Close up the media plate on hand medical technicians working on bacteria culture and drug resistance of pathogens in laboratory; bacterial identification.

Given that early treatment of sepsis is associated with vastly improved outcomes, rapid diagnosis is essential. However blood culture work is slow and often takes 1-3 days. The diagnosis of sepsis in critically ill patients, housed in hospitals is also challenging because it can be complicated by the presence of inflammation resulting from other underlying diseases and from prior use of antibiotics, making cultures negative. Most testing is done through mass spectrometry that gives mass to charge ratio of ions. Since culture-dependent diagnosis of infection is slow, sometimes patients are given antibiotics, before the results of the culture are available. Patients are given broad spectrum antibiotics and 40% are not effective. In such instances, antibiotics are withdrawn after one cycle of treatment, when the cause of the illness is found to be something else and this can lead to antibiotic resistance.

Bioaffinity Sciences solution will be able to identify pathogens within 10 minutes, 430 fold faster than blood culture. This is cell affinity based, low cost technology. Pathogens are run through microchannels comprising of a surface- grafted scaffold of reactive polymer onto which affinity molecules (sugars, aptamers, vancomycin, and methicillin) have been bio-conjugated. High capacity of the channels allows low numbers of microbes to be quickly identified. The unknown pathogen’s pattern of binding to the channels is recorded, and this pattern is compared to a library of known pathogens. When a match is made, the identity of the pathogen is reported. In addition to speed, this is also more sensitive in terms of the number of different pathogens detected than blood culture.

Disease burden to the healthcare system in the US due to Sepsis

Sepsis management is a major challenge and results in disproportionately high burden in terms of hospital utilization. The average length of stay for sepsis patients in the US is approximately 75% greater than for other conditions. The cost of sepsis management ranks highest among hospital admissions for all disease states. The cost is estimated to be between $25 billion and $27 billion, and represents 13% of total US hospital costs.

Considering that poor sepsis outcomes are directly tied to the delay in diagnosis and treatment, such a dramatic improvement in speed and accuracy of diagnosis leading to speedy and accurate treatment can not only dramatically improve outcome and quality of patient care but also significantly reduce cost of care for hospitals.

The talk was followed by Q&A.

 

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Antibiotic Resistance: A Mounting Threat of Epidemic Proportions


Dr. Deepti Jaggi, Co-founder, President and Chief Medical Officer of clinical stage biopharmaceutical company, Vivonyx, talked about their innovative lifesaving antibiotic therapies that can target resistant strains and prevent bacterial resistance at http://www.bio2devicegroup.org . Dr. Jaggi has spent 20 years in the Healthcare & Lifesciences industry and is a co-founder of multiple biotechnology companies including Novakos, a Lifesciences accelerator and Neurokos Inc., a clinical stage neurology company. Vivonyx has a product portfolio based on over 25 years of research, significant in-vitro & in-vivo data and multiple proof of principle clinical studies.
Dr. Jaggi began her talk with discussion on the enormity of the problem of antibiotic resistance and by giving the history of antibiotic therapies and resistance mechanism. Infections resulting from resistant microorganisms do not respond to conventional treatment and frequently result in death. Sometimes patients admitted for common elective surgery enter the hospital and catche an infection in the hospital and do not leave the hospital, alive. Further, people get ventilator associated pneumonia, catheter induced bloodstream infections, surgical site infections, in addition to health care related infections, with mounting healthcare costs. For instance, each ventilator associated pneumonia costs upwards of $50K. All infections are treated with antibiotics and many people are developing resistance frequently to first line of treatment. The problem is extremely serious in developing countries. For instance, out of the million Chinese who develop TB every year, it is believed that, 110,000 get a form that is resistant to the mainstay drugs. Patients with such multidrug-resistant or MDR tuberculosis have to be treated for up to two years with expensive second-line drugs that are toxic and less effective. Worse yet, there are recent indications that close to 10,000 Chinese are coming down with extensively resistant or XDR-TB, meaning that it is also resistant to at least two of the second-line drugs — and thus may be incurable in many cases. Due to many reasons including, inadequate national commitment to a comprehensive and coordinated response until recently, ill-defined accountability and insufficient engagement of communities and healthcare providers and pharmacies, weak or absent surveillance and monitoring systems, uncertain supply of medicines, inappropriate and irrational use of medicines, lack of education, and often poor infection prevention in the first place, lead to the problem of antibiotic resistance in enormous proportions.

So what is AMR or antimicrobial resistance? Antibiotic resistance is a type of drug resistance where a microorganism is able to survive exposure to an antibiotic. Dr. Jaggi asked “what would you do if someone tries to hit you? You would try to duck. And if you survive, and they try again then you get better at pre-empting and ducking every time there is a slightest threat”. While a spontaneous or induced genetic mutation in bacteria may confer resistance to antimicrobial drugs, bacteria are even more efficient. Genes that confer resistance can be transferred between bacteria in a horizontal fashion by conjugation, transduction, or transformation. Thus, a gene for antibiotic resistance that evolves via natural selection may be shared. Evolutionary stress such as exposure to antibiotics then selects for the antibiotic resistant trait. Active efflux is the mechanism that contributes to bacterial antibiotic resistance. Some efflux systems are drug-specific, whereas others may accommodate multiple drugs, and thus contribute to bacterial multidurg resistance or MDR. Efflux pumps are transport proteins involved in the extrusion of toxic substrates (including virtually all classes of clinically relevant antibiotics) from within cells into the external environment.

A great deal of Vivonyx work is still under wraps. But Dr. Jaggi shared broad information about the company’s focus and then made a business case for the same. Vivonyx technology is focused on suppressing antibiotic resistance, and developing antibiotics with significantly improved efficacy, expanded antibiotic spectrum and restored activity in resistant strains. Vivonyx technology works with a broad variety of already well-established and widely used antibiotics. Vivonyx is working on therapies that prevent drug resistance environment, can drop mutation prevention concentration, shorten duration of therapy, and prevent resistance in bacteria because they do not mutate. Making a strong business case, Dr. Jaggi began by saying, antibiotics is a huge problem, with growing market, and tremendous success rate with over 28.1%. This is a classic short term drug, with excellent in-vitro correlation which makes an excellent case for clinical development. The test done with the patient’s culture is the same test done in the Petri dish. There is a highly attractive exit potential, as is evident in case of all previous antibiotics. Often a deterrent to antibiotic innovation is that a new drug is kept as a second or third line of treatment for resistant cases. In this case however, it can be used as primary line of treatment since it does not lead to resistance. Finally, the GAIN act that recently passed in the house and the senate and is about to become a law, with an aim to provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process is fast tracking FDA review process. And the bill is extending the exclusivity period for new qualified infections disease products by five (5) years. The talk was followed with Q&A and discussion on issues including whether or not one should extensively use over the counter antimicrobial products and other questions that the audience had for Dr. Jaggi. For further information, please refer to http://www.vivonyx.com .

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