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− | <li> • | + | <li> • <b>Eosinophilic esophagitis</b> is a chronic, allergic inflammatory disease of the esophagus. |
+ | |||
+ | </li> | ||
<li> • The prevalence of EoE is around 0.1% cases worldwide <a href="#EoEper" aria-describedby="footnote-label" id="EoEper-ref"> </a>.</li> | <li> • The prevalence of EoE is around 0.1% cases worldwide <a href="#EoEper" aria-describedby="footnote-label" id="EoEper-ref"> </a>.</li> | ||
− | <li> • | + | <li> • Patients can take corticosteroids but most patients focus on managing and/or modifying their diet <a href="#diet" aria-describedby="footnote-label" id="diet-ref"> . </li> |
</ul> | </ul> | ||
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<li id="Dahl">Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. <a href="#Dahl-ref" aria-label="Back to content">↩</a></li> | <li id="Dahl">Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. <a href="#Dahl-ref" aria-label="Back to content">↩</a></li> | ||
− | <li id="RA">https://www.who.int/chp/topics/rheumatic/en/<a href="#RA-ref" aria-label="Back to content">↩</a></li> | + | <li id="RA">World Health Organization. https://www.who.int/chp/topics/rheumatic/en/<a href="#RA-ref" aria-label="Back to content">↩</a></li> |
<li id="EoEper">Dellon E. S. (2014). Epidemiology of eosinophilic esophagitis. Gastroenterology clinics of North America, 43(2), 201–218. https://doi.org/10.1016/j.gtc.2014.02.002<a href="#EoEper-ref" aria-label="Back to content">↩</a></li> | <li id="EoEper">Dellon E. S. (2014). Epidemiology of eosinophilic esophagitis. Gastroenterology clinics of North America, 43(2), 201–218. https://doi.org/10.1016/j.gtc.2014.02.002<a href="#EoEper-ref" aria-label="Back to content">↩</a></li> | ||
+ | |||
+ | <li id="EoEper">American Academy of Allergy, Asthma and Immunology. https://www.aaaai.org/conditions-and-treatments/related-conditions/eosinophilic-esophagitis <a href="#EoEper-ref" aria-label="Back to content">↩</a></li> | ||
Revision as of 16:42, 24 October 2020
The design of the patch
- Porous nanofilm → A porous nanofilm will allow interleukins to diffuse into the patch and prevent the yeast cells from escaping.
- Genetically modified yeast sensor → Our idea is, that in manufacturing the yeast will be dehydrated and placed in the patch in dry yeast format. This allows for easy storage and transportation of the patches at room temperature, which significantly reduces both cost and carbon emission related to the distribution of the patch.
- Adhesive patch → Common transparent plastic or woven fabric (such as nylon) used by bandage manufacturers.
Safety
- Life switch: Make the yeast dependent on a compound and coating the patch with this source of survival that is not easily found outside the patch.
- Kill switch: In the patch a constitutive anti-toxin would be present to neutralize the toxins in yeast for as long as it is in the controlled environment. But if it leaves that environment, the anti-toxin would be inactivated, toxin would be activated, and the yeast would be killed.
Who will use it?
- • Crohn’s and Colitis are inflammatory bowel diseases giving inflammation in the digestive tract .
- • It is estimated that ca. 3 million adults have Crohn’s disease or Ulcerative Colitis in the US .
- • Around 80% of patients switch medication type within the first year (Doctor Johan Burisch)
- • Rheumatoid arthritis is a chronic disease that causes inflammation mostly in the joints.
- • It is estimated that 1% of the world population has RA (nearly 80 million people!)
- • Patients sometimes try as much as 20 different treatments (Expert Anna Fryxelius )
- • Eosinophilic esophagitis is a chronic, allergic inflammatory disease of the esophagus.
- • The prevalence of EoE is around 0.1% cases worldwide .
- • Patients can take corticosteroids but most patients focus on managing and/or modifying their diet .
Why focus on these diseases?
Our research shows that patients with Crohn’s and Colitis would be ideal for our product and the survey we designed for this patient group corroborated this. Our survey indicated that patients with Crohn’s or Colitis underwent frequent medication change, and needed to test their inflammation levels often. Furthermore, In Denmark a new self-testing initiative has already been tried out on Crohn’s and Colitis patients, where they self-monitor their inflammation through stool samples at home. The results have been very promising so far according to Johan Burisch .People with Rheumatoid arthritis (RA) can experience wild spikes in inflammation without symptoms and testing is therefore a prime concern for many. Unfortunately, testing for RA patients can be expensive as ultrasound and other expensive testing methods can be necessary. This often means that testing happens too infrequently, and when testing does occur it can be too late, and the disease has already done irrevocable damage. Our product could fit into the new “treat to target” treatment paradigm, which focuses on closely monitoring inflammation levels and administering drugs accordingly.
Lastly, Eosinophilic Esophagitis (EoE) represents a group of patients who undergo many very extensive and invasive tests in the period where they -together with their doctors- try to map their reactions to certain foods. It can often be a tedious process with various diet trials and many hospitals visits, especially for patients who are asymptomatic and not aware of their bodies' internal reaction to their sustenance. Easy inflammation monitoring at home could make a huge difference for this patient group during their long diagnosis process according to our conversation with EoE patient Jessica Chrzan.
The problems in short
Why are we the solution
Real time tracking
User Guide
Mock-up instructions for the home kit guide:Step 1
Wear this patch regularly to track your inflammation and monitor your treatment. The patch can be used for tracking is 1-2 times a week, however we recommend specifying the interval with your doctor. Especially while monitoring a new treatment, frequent usage is optimal.
Step 2
Remove the thin translucent layer at the bottom, and without touching the adhesive, place the patch either on your upper arm, stomach or chest- any place with easy sweat access and minimal friction. Gently rub the patch after placement to ensure it sticks properly to your skin. Do not reuse the patch if it falls off.
Step 3
Wear the patch for approx. 6 hours. You will see the aptch changing color depending on your inflammation level. Remove the patch, place it on a flat surface with a neutral background, and take a picture using the CIDosis app on your phone. If you observe drastic color change (dark pink, red), contact your doctor
Step 4
Storage: Room temperature Caution: Keep away from children below 10 years of age. Parental supervision is mandatory if the child is under 10 years of age to use the patch. Do not tamper with the patch by trying to tear it, open it or putting it in your mouth. Do not bring flames near the patch or wetting it before use. Do not wear the patch in your shower or while swimming. Do not reuse a patch
How to get the product to the users
After doing some research we decided that our product could be marketed as a non-prescription device. A non-prescription marking would provide easier access to our device for interested CID patients. According to Sundheds- og Ældreministeriet (Ministry of health and the aged) there are four key considerations when deciding whether a medical device or drug should be prescribed.
- • Can the device or drug pose a health risk to the patient if administered without medical supervision (even when used appropriately)
- • Can the device or drug pose a health risk if used excessively and incorrectly
- • Does the device or drug contain substances that need to be monitored?
- • Does the drug need to be injected by a needle or similar
We believe that our device comfortably falls outside the aforementioned categories. Assuming that the user does not have any relevant allergies (such as yeast-allergies) the device should not pose a health risk when used without medical supervision. Similarly, excessive and incorrect use should not pose a health risk given that the device does not contain harmful substances. This also means that there is no need to monitor the materials of the device. Naturally, our device does not need to be injected, so it also falls outside the last category.
There is however some downsides to going for a non-prescription marking. Because prescription devices always needs a doctor’s approval, doctors will likely be more familiar with these options. Even today, where many patients go to the internet for medical recommendations, the doctor's opinion naturally carries some weight . Going non-description means that we can not necessarily count on doctor endorsement. As such, it is important to make a co-ordinated effort to get doctors’ endorsement.
User safety
During the Nordic Ethics Workshop, the Stockholm iGEM team enlightened us on the susceptibility of patients with celiac disease to yeast infections. We thought about incorporating that and troubleshooting on how we could ensure the safety of our patch in immunocompromised patients. Such patients could then use a specially designed, yeast-free patch. After wearing it on the skin for a certain period - long enough to collect the sweat - place the patch in a box containing yeast at the bottom. The rest of the mechanism would remain the same and the solution would produce a color change. This two-step process could benefit patients who could not use the patch due to gluten allergy, celiac disease or other diseases where one is immunocompromised. Unfortunately, patients with allergies to the patch materials and skin allergies may not be able to use the patch. However, at CIDosis, we hope to overcome this challenge with more research and design modifications.Framework for environmental analysis
The most obvious concern is the greenhouse emissions produced by a CIDosis patch. However, there is a lot of factors that one needs to consider when analyzing greenhouse emission impact . For example, one needs to consider the direct and indirect impact of our product, the potential cumulative impact and the risks associated with those potential impacts.
The direct impact of our product would be the emissions produced by production, transportation and disposal of the product. The indirect impact could be the potential shift in demand away from blood tests produced by our product. This could amount to reduced emissions due to fewer hospital visits, and reduced transportation need.
The cumulative impact could be the gradual increase in emission due to increased patch disposal. This type of impact can be either additive or synergistic, meaning that the impact is either equal to the sum of the individual parts, or greater than the sum of the parts. The goal is to ensure the patch creates emission only at minimal additive levels, without causing negative synergistic environmental effects.
In order to help us navigate the complexities of making such an analysis we had a talk with Hanne Dalsgaard Nicolaisen. She walked us through how to make a life cycle assessment. Click below to see the steps.
Step 1
The first step is defining a functional unit for your product. Doing a life cycle assessment is usually comparative process and one should start with figuring out how much of your product is needed to perform the same function as an alternative product. A natural comparison for our product is blood tests. However, comparing the two is not entirely fair as we are intended to be a supplement to blood test. It is nevertheless a good aim to make our product less impactful than blood tests.
Step 2
The second step is making an inventory analysis for both the functional unit, and the unit it is compared to. The inventory analysis should map out the environmental impact of each of the individual parts that features in the functional unit or the unit it is compared to. There is usually some uncertainty about the exact amount of environmental impact Individual parts have, so estimations are usually needed. Given that we are dealing with uncertainties, we should also estimate the likelihood that an alternative environmental impact is associated with each of the parts. Each of these possibilities, along with their likelihood, should be featured in the final analysis.
Step 3
The third step is the impact assessment. First one should decide which impact category one wishes to investigate. For example, is it relevant to know more about greenhouse emissions or is it more relevant to know the impact on the local environment?
Step 4
In the fourth step we should already have an idea of the impact our product has on the relevant category. Now it is time to make a sensitivity analysis. This involves evaluating how the analysis changes if the value of one of the variables in the analysis changes. This is done to test the robustness of the analysis.
The implementation challenges
Other Inflammation: could provoke misreading, or virtually false readings of the inflammation (as the cause will be other than the caused by the disease). Could be local inflammation after a hit or systemic after doing physical exercise.
Precision: we should consider how to improve precision. We should investigate when exactly during the day the readings would be more precise, how much time should the patch be worn and how many readings would be necessary to get a proper idea of the levels.
Yeast survival or activation from dried yeast: We must study how to dry the yeast without damaging it, and how would it behave when getting in contact with the sweat. We should study how much time it would take to activate and start sensing biomarkers. Probably, we will have to optimize it for a faster reading.
Acceptance of GMO: The way we convey our message should be cautiously thought, as we have seen that a proper explanation of the modifications of the yeast would exponentially increase the acceptance rate of GMOs.
Price of the patch: We should calculate the price taking into consideration several aspects: market analysis (competitors), level of increased wellbeing (willingness for consumer to pay), and the business plan (consider the return on investment and the money needed for further steps).
How can other scientists use our project?
- Crowd source science on sweat and diseases
- Novel method of expressing IL-receptors in yeast -G-alpha modifications that other igem teams can use
- platform for further diagnostics??
- Baumgart, D. C., & Sandborn, W. J. (2012). Crohn's disease. The Lancet, 380(9853), 1590-1605. ↩
- Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. ↩
- World Health Organization. https://www.who.int/chp/topics/rheumatic/en/↩
- Dellon E. S. (2014). Epidemiology of eosinophilic esophagitis. Gastroenterology clinics of North America, 43(2), 201–218. https://doi.org/10.1016/j.gtc.2014.02.002↩
- American Academy of Allergy, Asthma and Immunology. https://www.aaaai.org/conditions-and-treatments/related-conditions/eosinophilic-esophagitis ↩
- https://www.retsinformation.dk/eli/retsinfo/2019/9003↩
- https://www.retsinformation.dk/eli/lta/2019/1297↩
- Chernew, M., Cooper, Z., Larsen-Hallock, E., & Morton, F. S. (2018). Are health care services shoppable? Evidence from the consumption of lower-limb MRI scans (No. w24869). National Bureau of Economic Research ↩
- Eccleston, C. H. (2011). Environmental impact assessment: A guide to best professional practices. Crc Press. ↩