Sepsis is a lethal and widespread complication of infections. The increasing incidence of sepsis, along with the need for rapid and accurate diagnostic methods, presents a significant market opportunity for DNA aptamer biosensors in lactate detection. Moreover, rural Canada endures the highest incidence of sepsis-related complications and is a promising indication of where this technology can be piloted. Lactbio’s DNA Aptamer-driven lactate technology is a fast-acting test that optimizes the ability to identify the onset of sepsis and increases the efficacy of treating sepsis patients in rural Canada.
1: Market[edit | edit source]
1.1 Problem/Customer[edit | edit source]
Sepsis is a serious and lethal complication of infection. One in three hospitalized people who pass away experienced sepsis1, and the disease affects 30 million people worldwide yearly.2 In Canada, 1 in 18 deaths involve sepsis, with it contributing to or underlying over half of the infection-related deaths. Further, remote communities are at an increased risk of sepsis because of socioeconomic factors that affect their health, including inadequate housing, poor nutrition, unsafe drinking water, and comorbidities (such as diabetes), with consequently higher rates of injuries, respiratory infections, and skin and soft tissue infections.
Sepsis is the product of a contracted infection catalyzing an extreme reaction throughout the body—usually starting in the lungs. Not only can it be the product of any type of infection (bacterial, fungal, or viral) but anybody can contract this illness.
Unfortunately, the symptoms of sepsis are broad and common with other illnesses, so further medical assessment is needed to confirm sepsis. This is usually done via taking a wound culture, respiratory secretion testing (or a septum culture), testing blood pressure, or imaging studies (such as a CT scan).3 These current methods for assessing sepsis may take too long to deliver results and may not be accessible to patients in dire situations and remote areas. Currently, lactate levels are used to assess the onset of sepsis. These levels are measured using laboratory-based methods, which can be time-consuming and require specialized equipment and trained personnel. This rings true, especially in rural communities, where resources, cost, and spacing issues prevent the implementation of traditional sepsis assessing techniques, thereby preventing a time-sensitive diagnosis.4 When comparing rural and urban areas, rural patients afflicted with sepsis have a consistently higher mortality rate than those from urban populations. Studies indicate that approximately 30% of patients diagnosed with severe sepsis do not survive and that the risk of death increases by 8% for every hour of delayed treatment.5 These obstacles decrease the ability to treat sepsis and can result in a death that may have been preventable.
By providing a lightweight and rapid way to screen for lactate levels in the diagnosis of sepsis, our goal is to decrease the time spent identifying sepsis to positively increase patient outcomes in rural Canada.
1.2 Problem Scope[edit | edit source]
Though mild sepsis can easily be overcome, it can quickly form into septic shock. Septic shock causes numerous life-threatening changes, such as a severe drop in blood pressure, respiratory failure, and multiple organ failures. The appearance of sepsis is also increasingly relevant, with an 8.7% increase in sepsis cases annually.6 Sepsis is also a major cause of morbidity and mortality in Canada and is associated with a significant economic burden on the healthcare system. These problems demonstrate how assessing and treating sepsis in a time-sensitive manner can be potentially life-saving.
According to the Canadian Sepsis Foundation, sepsis is estimated to cost the Canadian healthcare system over CAD 1 billion annually.7 Moreover, Canada’s Drug and Health Technology Agency indicates these trends are amplified for the 6 million individuals living in rural communities (Exhibit 1). These populations typically experience higher rates of medical emergencies, especially infectious diseases.
The market potential for DNA aptamer biosensors for lactate detection in the diagnosis of sepsis is significant. According to a report by Grand View Research, the global biosensors market was valued at CAD 36.3 billion in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 8.0% from 2023 to 2030.8 Our potential market capture of $36.3 million is illustrated in Exhibit 2.
The increasing incidence of sepsis, along with the need for rapid and accurate diagnostic methods, presents a significant market opportunity for biosensors, including DNA aptamer biosensors for lactate detection. Moreover, rural Canada exhibits the highest alignment with this problem and therefore is a promising indication of where this technology can be piloted.
2: Technology[edit | edit source]
2.1 Solving the Problem[edit | edit source]
Lactbio’s DNA Aptamer-driven lactate technology is a fast-acting test that optimizes the ability to identify the onset of sepsis and increases the efficacy of treating sepsis patients. Specifically, Lactbio’s DNA Aptamer-driven technology closes the treatment gap that medical facilities in rural areas face as a result of resources, cost, and spacing barriers. Equipped with our technology, medical clinicians in rural Canada can provide the best opportunity for reducing the sepsis mortality rate, the amount of time spent on a patient, and how long sepsis patients may be hospitalized. Lactbio technology shows promise of reducing the overall costs associated with sepsis diagnosis and treatment.
Lactbio's handheld design highlights the versatility, and robustness of this lactate test. In the application of this product, a sample of the patient’s saliva must be taken with a swab. The sample can then be mixed into the Lactbio tube, which hosts a solution that hosts the mixture of salivary biomarkers with our DNA aptamer technology. Once the aptamers and the lactate are combined, they will link and emit light. This tube will be inserted into our fluorescence detector, which will then read the indicator and output a lactate analysis within minutes; indicating whether the patient has sepsis (Exhibit 3). Medical institutions will only require two fluorescence devices, which are used with Lactbio’s low-cost DNA Aptamer and test tube kit.
The use of DNA aptamer biosensors for lactate detection offers several advantages over traditional laboratory-based methods, including faster turnaround times, lower cost, and the potential for point-of-care testing. Reinforcing the impact of Lactbio technology is information gathered from a conversation with an emergency room physician (Exhibit 4). Lactbio’s Aptamer technology addresses the core problem that rural communities face of promptly identifying sepsis and further administering an appropriate course of treatment.
2.2 Competitive Advantages[edit | edit source]
DNA Aptamer technology holds many advantages over current technology in the lactate testing market. This is best illustrated through the following key advantages:
Low maintenance: Unlike enzymes or proteins that require prosthetic groups, DNA aptamers require no additions to function. They can be packaged and sent fully modified and ready to use.
Non-invasive: DNA aptamers function non-invasively; the use of a saliva sample is particularly advantageous in emergency room situations where other treatments can be given simultaneously, as opposed to invasive sepsis testing that disrupts the administration of other treatments.
Accessible: Our technology is light and portable. In kit form, it can travel throughout the hospital to the patient, rather than the inverse where the patient must be transported to the technology. This has benefits in rural areas with no space for imaging technology.
Rapid: DNA aptamers operate instantaneously. Unlike other sepsis testing where a culture needs to be formed, a short time span is necessary in urgent settings.
Implementation: This technology is easily implemented within the current clinical workflow, meaning that it is easily adopted into the medical emergency infrastructure.
Cost: DNA Aptamers are low-cost and significantly cheaper than blood tests used for lactate analysis.
2.3 Technological Readiness[edit | edit source]
Lactbio’s Aptamer-driven lactate test is approaching the mid-phase of commercialization such that foundational research has been finalized. The DNA Aptamer biochemical reaction and fluorescence detectors are reliable and researched concepts, which indicate a promising stage of technological readiness. Specifically, we fall within the development stage, as highlighted in grey in Exhibit 5. This technology is set to be incorporated in an early-stage prototype and further piloted with emergency medical facilities and physicians.
3: Technology to Market[edit | edit source]
3.1 Beneficiaries[edit | edit source]
Lactbio’s technology is designed for use by patients at risk of contracting sepsis. The nature of the disease necessitates Lactbio technology’s use in hospitals and emergency clinics, where it can be fully utilized to reach the patients who need it. Specifically, Lactbio will be used across rural and remote Canadian hospitals—mortality from preventable causes accounted for approximately 1% of the rural Canadian population, as opposed to 0.1% in urban communities.9 Rural populations, when asked what diagnostic tool their facility has available on-site for sepsis detection, indicated the most common tool is urinalysis, followed by laboratory services for blood/wound cultures and imaging (such as CT scans).10 When asked specifically about lactate testing, no respondents indicated its availability in remote health care settings, indicating a need for Lactbio’s technology.11 Such resources are not as widespread in rural communities as urbanized ones and do not provide the fastest response times for a diagnosis, as such Lactbio will target itself to the rural hospital departments and clinics that require it.
3.2 Customers [edit | edit source]
Lactbio’s technology will be bought by rural hospital boards; due to bioethical and health concerns, the process of purchasing medical technology requires an initial assessment of the technology, then following the acquisition, there are maintenance, upgrades, and replacements at the end of the product lifecycle. The initial review process entails qualitative and quantitative evaluations dependent on the cost of the technology, involving many hospital departments; Lactbio’s primary reviewers will be the intensive care unit (ICU), emergency rooms (ER) and laboratory departments. Hospitals consider a cost-benefit analysis when deciding on new technology, and with Lactbio’s low operating cost, rapid-acting, low maintenance, and high accessibility properties, hospitals will be encouraged to purchase Lactbio over other lactate-detecting technology. Lactbio’s detection device can be used multiple times with a new swab for each patient; we presume each hospital department (ICU, ER, and lab) will purchase two detection devices, with the management of each department directly paying for the technology.
3.3 Production, Distribution, Maintenance & Sales[edit | edit source]
Lactbio is proposing a two-stage strategy (Exhibit 5) to ensure successful market integration for the new DNA Aptamer lactate testing technology. Within the first stage of scaling Lactbio will develop a working prototype. This is attainable given seed funding that will be acquired from local entrepreneurship programs (Morisette, London Small Business Centre) and technical guidance from faculty and medical experts at an educational institution. This working prototype will live under a start-up model for the first two years, in which key relationships with rural medical partnerships will be developed to enable application-specific testing. In these early stages, sales and distribution will be executed by the Lactbio team. Given only a few pilot programs will be run in these first years it is feasible for our team to test and demonstrate a promising commercialization strategy for DNA Aptamer lactate testing. The objective in the first two years will be to develop a foundation of successful trials and initial customers who can jumpstart interest in the product.
With quantifiable data and proof of concept testing from the Lactbio startup, this technology will be a desirable option for 3rd party manufacturers. Lactbio’s 2nd stage of commercialization is to license our technology to biosensing companies already established in the industry. The revenue model at this stage will be based on receiving royalties from sales. All core functions including production, distribution, maintenance & sales will be managed by the licensee. Research indicates that in 2021 over 122 Canadian biosensing companies received VC funding with top players being AbCellar (Biotechnologies), Imagia (Healthcare), and Aspect Biosystems (Biotechnologies). Each of these listed companies are potential partners to scale Lactbio technology in our 2nd stage of commercialization. Overall, we also note an added benefit of this technology is its low maintenance. It can be maintained at room temperature and has a shelf life similar to, or longer than, its antibody or enzyme counterparts. The biosensor itself relies on a fluorescence detector, which has little to no maintenance.
3.4 Opportunity Scale[edit | edit source]
The severity of sepsis remains even as technologies advance and it is clear there is a need to improve the technology currently used to detect it. The earlier sepsis is diagnosed, the lower the risk of organ failure and eventual death. Canada’s total sepsis-related expenses are estimated to amount to $325,000,000, this is largely due to the fact that once a patient has sepsis they are more likely to return to the hospital due to a weakened immune system.12 The implementation of Lactbio’s technology will reduce government healthcare spending, allowing for money to be allocated to initial healthcare needs (sepsis treatment) rather than returning patients whose sicknesses can be mitigated. By introducing a technology that detects sepsis quicker than existing devices, Lactbio will be readily accepted in the market.
Although we intend to pilot this product in rural and remote regions of Canada for early-stage development and testing, Lactbio technology shows promising scalability in urbanized areas, as it can be easily integrated with existing diagnostic procedures, and as a tool for medical professionals working in the field in developing countries (Doctors without Borders).
Endnotes[edit | edit source]
1. “What Is Sepsis?” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, August 9, 2022. https://www.cdc.gov/sepsis/what-is-sepsis.html.
2. “How to Prevent Sepsis - the Role You Can Play in Health Care and Communities.” YouTube. YouTube, May 3, 2018. https://www.youtube.com/watch?v=GKRQm0i5JdI.
3. “Sepsis: Symptoms, Causes, Treatment & Prevention.” Cleveland Clinic. Accessed February 21, 2023. https://my.clevelandclinic.org/health/diseases/12361-sepsis.
4. “Management of Life-Threatening Asthma - Chest.” Accessed February 22, 2023. https://journal.chestnet.org/article/S0012-3692(22)00395-6/fulltext.
5. “What Are the Three Stages of Sepsis?: Levin & Perconti.” Levin & Perconti, October 14, 2022. https://www.levinperconti.com/nursing-home-abuse/sepsis/stages/.
6. CDC (2021)
7. CDC (2021)
8. “Global Biosensors Market Size Analysis & Growth Report 2030.” Global Biosensors Market Size Analysis & Growth Report 2030, www.grandviewresearch.com/industry-analysis/biosensors-market.
9. Government of Canada, Statistics Canada. Preventable and treatable mortality by remoteness. Government of Canada, Statistics Canada, May 15, 2019. https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310039001.
10. “Detection and Diagnosis of Sepsis in Rural and Remote Areas of Canada: An Environmental Scan.” CADTH. Accessed February 22, 2023. https://www.cadth.ca/detection-and-diagnosis-sepsis-rural-and-remote-areas-canada-environmental-scan.
11. CADTH (2023)
12. Canadian Sepsis Foundation - Understanding sepsis, n.d. https://canadiansepsisfoundation.ca/Understanding-Sepsis.
13. Canadian Institute for Health Information, In Focus: A National Look at Sepsis (Ottawa, Ont.: CIHI, 2009).
14. Canadian Sepsis Foundation - Understanding sepsis, n.d. https://canadiansepsisfoundation.ca/Understanding-Sepsis.
15. “What Are the Three Stages of Sepsis?: Levin & Perconti.” Levin & Perconti, October 14, 2022. https://www.levinperconti.com/nursing-home-abuse/sepsis/stages/.
