MEDICAL DIAGNOSTICS

In recent years, biotechnology including medical screening has been rapidly developing. More new test products were born in the past twenty years than all test products previously available twenty years earlier. From time consuming laboratory analysis to convenient and quick results immunochromatographic assay, or rapid test, is one of the most important developments in screening during this period.

Swiss Mediscan In Vitro Rapid Test PRODUCTS

All Swiss Mediscan Rapid Test Products are manufactured in a GMP, ISO 13485-2003 Certified Factory which are pioneers in manufacturing rapid test kits. We are committed to manufacturing quality screening products with ongoing research and development, guided by the highest standards and acquiring scientific knowledge through our own research and collaboration with scientists from the United States, Canada, China and Malaysia. We also focus on delivering high quality rapid test products for the point of care/ collection (POC) test market with innovative designs.

THE MAIN ADVANTAGE

What gives the advantage to SWISSmediscan is the fact that the products already have FDA in Asia and with a proven track record in rual areas which will be generated in the beginning of 2018, the expense in distrubution foreign countries and registering products for distribution will be minimal as independent evaluation of the products won’t be required in most cases, not to mention that the products distributed by SWISSmediscan are ISO approved, FDA approved, Moody’s regulated and CE certified. So all the hard work and initial setup including R&D is now complete we can virtually open the doors and go straight into the marketing some regions. The value of this is priceless to a new company entering in the medical field as most companies are destroyed by the cost of R&D research and development before they even open to sell.

LOGISTICAL CHALLENGES

Variation in the biology and pathogenesis of infectious diseases necessitates multiple approaches to their detection. For pathogens such as malaria or HIV that circulate in bodily fluids, or those that elicit a characteristic immune response the selection of samples to test is straight forward. For diseases such as TB or leishmaniasis sampling is more problematic as direct detection of the organisms is often difficult, particularly during early stages of the disease when treatment interventions that could prevent further transmission are most effective . Unfortunately tests for immune response to these diseases often lack specificity and cannot differentiate past or latent infection from active disease . One of the challenges shared by all test developers is access to well characterized samples with which to validate their tests. SWISSmediscan has already past this stage .

To address this issue the WHO and some not for profit organizations have established specimen banks where clinical samples are curated and made available to test developers designing tests for developing countries. An example is the tuberculosis specimen bank that is currently managed by the Foundation for Innovative New Diagnostics (FIND) which may be accessed via the website

www.finddiagnostics.org/programs/tb/find_activities/tb_specimen_bank. Characterization of samples from TB patients is particularly problematic. Extra-pulmonary disease and pediatric cases are often difficult to detect and evidence from autopsy studies from settings with a high prevalence of TB suggests undiagnosed extra pulmonary disease may be present in a proportion of the population .

Unlike sputum based tests, those that use blood or urine may detect all forms of the disease and misclassification of samples used in validation studies due to a failure to detect extra-pulmonary disease may lead to inaccurate estimates of test specificity.

There are additional challenges when working with infectious diseases, particularly deadly airborne pathogens such as M. tuberculosis which require microbiological

safety level III . The need for specialist handling and infection control facilities increases costs and is a disincentive to working with hazardous pathogens. Once validated in laboratory studies the performance of the device must be determined at sites of intended use. For devices intended for use at the point-of-care studies should take place in the clinic as studies undertaken in a referral or research laboratory may give a false impression of the robustness of the device.

Quality assurance and maintenance of equipment is often difficult to achieve in developing countries, particularly for devices used outside of the laboratory network and at the point-of-care. This may easier for devices that incorporate wireless or mobile phone technology, where information on usage and performance of the device can be collected remotely. However, connectivity (the state of being connected), is in its infancy for in vitro diagnostics and international standards or guidelines have not been implemented.

Where our advantages as opposed to other competitors is our grass roots approach to marketing and distribution. Due to the fact that our products of already passed most of the hurdles mentioned above we can immediately start distribution. Included in the purchase price and consultancy fee for McInnis co-Ltd of Marshall islands the first 12 months of the operations of the company are included in this amount and by utilizing this we will be targeting rural areas in Thailand where we are currently FDA approved . Our plan is to distribute free of charge to areas that cannot afford health care or do not have the facilities to test contagious diseases on site and we will obtain sponsorship from companies in those regions to support the locals by purchasing the IVD tests. This will produce positive feedback by local authorities and support of government departments and possibly NGOs. We will target repetitious for three main contagious diseases being that off Dengue fever and malaria and tuberculosis.

Currently the dilemma is when a doctor goes to test a patient in a rural area for Dengue fever. First you must take the blood then have it sent to a lab and some places the local Laboratory or the closest Laboratory is over 100 km away this process alone can take up to 1 to 2 days to get the results. Once the results are confirmed the doctor then must go back to the rual area ,find the patient and in some cases these patients have no records for identification . The then either place the patient into quarantine or begin treatment. In the case of malaria or then we feel that this time can mean the death of a young child. Dengue fever if diagnosed with in the first two days can be treated and basically treatment for this is pure water however past 2 to 3 days dengue fever to come to life-threatening.

Our goal is to have a team visiting rural areas throughout the rainy season which starts in the third month of 2018 and set up appointments and advertise free rapid testing for the above diseases. Our advantages that our IVD testing system gives result in 30 seconds ,if the result is read as positive , then secondary testing can be done with the laboratory ,however treatment can start immediately in order to possibly save a life. It is McInnes co Ltd belief that this kind of advertising will rocket SWISSmediscan to be a known name throughout the country of Thailand in a very short and rapid timeframe . With the above recognition we gain the support of all local business communities NGOs and government departments which gives us a project that we can possibly utilise in other countries based on the data gathered from the Thailand project .

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