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thank you very much thank you for the invitation and give me the
00:00:03
chance uh to speak about uh how we approach m. have
00:00:07
and how we approach uh to to to bring a diagnostic device
00:00:13
to the patient yourself in the meantime i change the title
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but but it's not that important um just a glance about human is so we
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are privately owned um small a medium and
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the price uh roughly nineteen voice
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found that forty years ago forty one years ago we are located
00:00:37
your bottle and we have affiliates in five different countries
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ah our mission is to develop the manufacturer and
00:00:45
to promote in in vitro diagnostics particularly
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um in in uh you should be brought up so technology we are using or
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most most of them are based on him the chemistry so eliza later flow essays
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uh you need to be made to guesses but we also uh or for some
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and semantic test and uh one seller s. a. in in allergy testing
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what we call reef these technologies in this essay is is the entire pie range from
00:01:15
group of a fully automated high throughput systems in in the big
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laboratories to the point of care essays even that patient homes
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so uh these are the topics i want to speak vertically about
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rational requirements challenges tool boxes for self a patient self testing
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i want uh to uh uh and to present you
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our leaving exceed it uh example which scroll ideal
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uh i want to give you some feedback by different stakeholders about this technology
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and i want to show you how we would like to transfer these our experience if i broke
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ah and that would technologies we find to talk to other applications halted the caesar yes
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so the rational but i think we should uh bring
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uh the i. d.s close to patients are ah
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there are a lot of chronic diseases and these are among the white most widespread
00:02:17
diseases oh most most light that help problems diabetes remote data to um
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a remote take these orders invest in testing about this is you could even
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uh c. uh at least parts of cardiac diseases are chronic diseases
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uh these patients usually uh need a lifelong treatment that lifelong crack care
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uh these diseases and most awfully presenting faces of remission
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relapse that's very important to money toward base
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uh if you molly tortillas usually these uh to an
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you should uh do we and on time only touring the so that you can do
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uh you can make feel protected stations very fast uh it's also important that
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you should detect the potential orderly upstairs early as possible and you react as early as possible so
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less intervention times usually lead to less hospital stays less either treatments
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pasta missions and ultimately also tool to less it costs
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and these early intervention strategies requires that patients are closely money torque of course not
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only a beef by marcus but also beep regular clinical uh i'm able asians
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and the patient can do the monitoring by her or
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himself so we should bring the test to them
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so some uh requirements we fought before we started project uh he's
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important for self monitoring to the patient's home so it will be home
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base which will be easy to use it's cleavage will be interactive
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uh and beside the two uh for the patient to do this he
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shall not require any other thing except his own smart phone
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ah of course these tests will generate that quantitative and objective results
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for in our case we need a quantitative probably quantitative result
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or let's say at least the let's say quantitative result and we should be it
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should have a high correlation b. b. for the lab results all these
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not only requirement this this was the most challenging part the side of the software development of the whole project
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to give the patient a biochemical face which works on to to to to we we for easy read out system
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so a each all allow flexible feces more need to ordering uh
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it allows a remote contact between or ritual our remote uh remote contact and close partnership
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between patients and the treating physician or or any other have kept a professional
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and b. b. think each all the if the patients more responsibility in managing
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he's for only sees so it's it's all about patient empowerment
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ah some challenges apart from the biochemical preston to
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read out system the challenges of primarily in
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in in that in that in a software development in smart on itself smart phones are
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on the one side we could to spot are very performing very different to have very different to ah
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we are in a at highly regulated area so we
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need to develop a soft than a complying to
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i so standards and many many other standards and the sometimes contradicts tool user friendliness
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so you could to ease your work flows but you are not allowed to because of
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regulations and so on so forth so another big issue is the thought the protection
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so we have all encrypted uh to the uh uh in the late to standards
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on one side on the other side you would like to have an
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immediate access to test result which is also contradicting a little bit
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so so we have solved this we have different views are labels and different uses c. different
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data on in in in uh the the web portal a big
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issue is is the storage and transfer of medical data
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uh it's very different real real regulated thinking different countries so different regions
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and um the the key at the smog form or the application uh and uh um
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i think this mopping doing this uh should be married
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illustrated automated you should uh
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it should easily look uh uh no in beach every and each country
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are these the patients staying and um so we need a a localisation forty for
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marcus so at that at the end to the the smart phone displays
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the core wrecked a illustrations the right language and so on
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and so forth so the tool boxes you need
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uh for patients self test things first of all uh you need a by a marker
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beach is uh and establish invalidated by market which is an objective theses marker
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and this is a prerequisite and these are a teaspoon replace it is is a very
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he sees full field in the case of intestinal bowel disease which is
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chronic lifelong usually starts very early um
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and uh it's it it has a relapse signalling between course the by a
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marker we uh established by marker to follow uh these uh these these
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the scalp protecting these propane of to from the s. one hundred family um
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eat on one side it is used by the use for diagnosis
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and differentiation between i. b. d. and all the diseases
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and numerous studies have shown that it can also be used protect the season therapy monitoring
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usually the results can be grouped in free categories like
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normal below one other michael graham programs too
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he'll be speak from remission normal coastal healing as it's been kinda caught
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there is a moderate level in between eight and forty disease grace own and
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apple for about three hundred uh this is our high battles usually
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you find values that these values up to several
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thousand inactive inflammation or in a relapse
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so the second part in the this a biochemical tests here uh we have decided for uh
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nope or for an old but maybe not so uh how to fashioned technology letter flow essay
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so you can easily uh detect better by marker is present or not
00:09:31
so it the bear market is present it binds the test line and be for a second uh
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uh antibody labelled beef cold in our case you can detect is also at best line
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if uh uh no and uh by mark or or no um a couple cookies present uh
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the gold label is scattered all only by the antibody in the c. line so here
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the c. line shows you that the test has worked correctly so very easy principle
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very easy to understand and the first part
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you need a he's he's he set a convenient read it read out
00:10:13
system we have decided for smart phone is a readout system uh
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we have developed a an application called colour and these collect uses the
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smart from camera to acquire the image of the test cassette
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so uh as as soon as the test had the salon so
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you take your smart phone put on the camera approach
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approach uh the uh and the test cassette them while approaching the
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press cassettes as years of picturing he's he's he's make
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and as soon as as as the the act finds and a sharp
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a sharp uh i'm picture are sharp enough it freezes and
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this is a kind of a freeze for picture so then
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it calculates a test light control line ratio and
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and be flawed specific a standard curve parameters um
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it calculates the result and displays it on smart phone
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ah the fourth part you need is a web portal equally the backend
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you need to do something which manages all the data so patient paper oh
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product specific data and so on so it's encrypted this two way communication beefy collette
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has already explained there are different user labels available so
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each user sees different amount and settings of data
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ah there is also the entire result history here of
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a patient is just maybe one patient uh
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he's he's he's on this web portal this web portal organise is also the exchange of of data between
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the the um patients marked for them be fun emails system
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of b. c. or small form of of the doctor
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so our living example is the i. b. though so
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we have integrated these four parts into one system
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so this is the tool kit i. b. talk a piece short for id doc i. b. d. doctor
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uh it's a tool for self monitoring of people about the status of the packed and
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the qualification of for patients to use this is not
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an over over the counter and the bias
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he he he called he qualified only few years under treatment
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and on the control of the treating physician so
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only then he gets a possible work uh to to enter into the i. b. top and he
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gets a such a task it's uh by description the only thing he has to provide his
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he's her own smart phone
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ah and patent that this is working like this it's even a little bit more complex
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than having a prick testing as you put two we've looked low cost money touring
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patient has to extract his own stool because the sample is is ordered by markers is measured things too
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so we have developed the signal and an easy device which
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allows the collection and quantitative collection quantitative extraction so
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a patient uh collects to uh makes us eat waits for certain time to to the soul
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for a a or to extract the the culprit taking out of this to uh
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a tax that effects the test to say it uh loads to
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discuss it um by using the small this both allows
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a quantitative to to uh that that wanted that they've uh drops drop one quantitative
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drop comes out of these device onto the loading port of this cassette
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after this the patient uh starts 'cause mark form
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hand off twelve minutes the smart phone rings
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and the patients take takes a picture s. eyes going before uh the result he's he's
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he's calculated automatically as soon as the results calculated takes about two seconds or so
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the patient got these uh uh gets these um uh i'm
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layout the result either be for quantitative number or not this can be decided by the treating physician
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by the setting on the web portal and we can add some
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notes today mice to was barely cracked or something like that
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and as soon as he saves this the result is sent to the portal to portal not be fights the doctor
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patient x. y. has done the test dot no result because we decide for security reasons no result are
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sent around so that the doctor has to go to the portal and look after these results
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uh_huh
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ah some some performance data so we have to wally
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date all these things um so first boss
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the performance of the smart phones per se it's a very busy slide only want to to concentrate on two two things ah
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it's very as i said at the very beginning difference mark phones give
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different road data because of their i q.'s because of their cameras
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of of the resolution of the cameras and if you would not correct the commerce
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and you would use this a generic standard curve parameter as i've explained
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you will uh get a very uh the diversity
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salts over the concentration range uh the uh
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these the um grey line feces that is the right chord concentrations determined by
00:16:17
by the references them and without correction uh you see
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the red lines after you have corrected these ah
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sold that that blinds are very close to do that to
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the real concentration so this correction is done automatically
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uh and that's why each smart phone has to be qualified
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to be used and how only off the correction
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it's qualified to do we have also measured playstation that reproduce
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ability and that they thought and also q. v. c.
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uh as compared to our that to our system uh which is uh
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use a a little uh letter flow read it uh for uh for the laboratory
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and uh the data are very close to a or north for
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for some data even better than than the quantum leap
00:17:14
we then we have done a method comparison in the lack so is do we
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get the same results not only for the readout but for the whole yes
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so we have done a about fifty extraction fifties collects miles we have low
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that that the that the i. b. dock and have done the photos
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and got the results we took this this uh colour twelve exactly devices broke them away and
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measured the same extract he he in in they have called will
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buy say beaches uh because the guy behind throughput essay
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and that the and uh we have so um we have not the perfect
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correlation but we have a a slope close to one and we have
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roughly null bias between the two systems so we
00:18:03
really get the same result in the i. b. dock us
00:18:07
with beef uh be fun establish hyphen put laboratory method
00:18:12
so this is also a little bit basic but uh just want to show you we
00:18:15
have done about ten a clinical performance thought they'd be free patience in real life
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uh two of time in the meantime r. p. review would prefer published in peer review review journal
00:18:29
so usually the setting is that and i didn't talk to start at home
00:18:35
and uh the patient takes a sample from the same school with
00:18:42
which he he was he had has been and he
00:18:45
was doing at the i. b. dock and send it to the lack intellects to was extract that once again
00:18:54
uh huh and nash should either on you i saw or on
00:18:57
the comparably data or on the on the um have culpable
00:19:02
and and some some of the data we got is that the prediction of
00:19:09
of a menu below one hundred micrograms program so so well i and
00:19:16
the cool in the study was how long beal my
00:19:22
patients be stable for the next time moments
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ah how long there will be no node a baby no relapse and
00:19:33
this is presented here so so these these negative predictive value or more or less the
00:19:38
same for the i. p. doc at home versus the laboratory method so about
00:19:44
eighty five to ninety percent uh of of of of the make negative results really turned
00:19:50
out that that it was no remission at their oscillation between the next four months
00:19:56
ah
00:19:58
uh the opus it was done ah how ballad last night to talk value pretty
00:20:04
can f. call value above three hundred micrograms program meaning there is active inflammation
00:20:11
uh there is a relapse and also the specificity and the positive predictive really almost quite high
00:20:19
i'm not just talking about data may may um most probably
00:20:22
the most complex studies the seer and we uh the
00:20:26
conclusion is that we have a self sufficient agreement to use this new test put the seas money touring
00:20:32
uh because you have a lot of concord and samples you have some samples which are all
00:20:38
over estimated by the i. b. doc the reason here is the rose to sample
00:20:45
cult protecting his not stable intros to samples some of the samples are
00:20:49
only display for more than five days at room temperature so we would argue and we have all to start this
00:20:56
ah a look that that that uh the ideal values
00:21:00
most probably more correct it's not over overestimate about
00:21:04
but just to sample just to try to to to relate to tear radiated well come on next uh
00:21:11
spell this word uh during the transport to the to the lad and that's most probably not
00:21:16
over estimation about bill the result in the lab was just wrong because corporate in boston
00:21:23
down
00:21:26
ah we have also done some human factor start they some usability start this ah
00:21:33
we have done about six thought this uh either as poor you usability studies or or as
00:21:39
a part of the all the studies i have presented to you and uh usually
00:21:45
the patients feel very well instructed they got about the fifteen minutes
00:21:49
training by they have care professional before they could use it
00:21:52
and they they have the t. v. at tutorial tutorials and yet they have a um
00:21:58
an easy um instruction for use it if you feel better well instructed if this
00:22:05
ah they think
00:22:09
they think we have done the test correct they were
00:22:13
also able to perform these these test because at
00:22:16
the end the c. result on the portable or the or the study i'm a p. ice
00:22:24
and very interesting result from one study was that
00:22:29
patients are asked do you prefer to do the test yourself a tool or do
00:22:35
you prefer to send to send in the stool sample so eighty five
00:22:39
uh percent said no why prefer to do test at home by myself
00:22:45
ah all these performances big tall
00:22:50
independent of h. and educational level as far as it was a a examined
00:22:58
and ninety seven percent of these sam out of this um study
00:23:02
participants said uh i would use these also in future
00:23:10
so be backed by the stakeholders
00:23:13
so i i did a piece in use we have about seventy last active
00:23:19
clinics which have installed the id doc in twenty one different countries
00:23:25
uh about fifteen hundred patients are actively using these
00:23:31
really in real life not been stop this
00:23:34
but they did the ad and the portal is available in twenty different languages in
00:23:39
the in the meantime you have six thirty six different validated smart phones
00:23:44
uh uh uh uh but very important feedback is opposed
00:23:50
to bitch with just a baby publish next week
00:23:54
at u. g. w. which we'll state it supported from island using might be doc has lead
00:24:00
to fewer hospital visit to reduce number of and those copies and two significant cost savings
00:24:08
we have a lot of farmer companies move beach are highly
00:24:11
interested uh in using these to get with their rocks
00:24:16
and we have a lot of interest by universities also offering different kind of perhaps uh
00:24:23
i have um have money touring apps scoring apps uh and they
00:24:28
would like to combine or tube to they would like to
00:24:31
to get the ivy doc resulting their rap so we have a lot of i a. p. i. projects going on
00:24:38
another thing is that we are allowed to sell this essay as a self test so we have got
00:24:44
uh i'm a a certification uh by not divide party for self testing
00:24:51
we have a a a the allowance use it industry on since a few months also
00:24:57
it's active a certified as it possibly device uh for self testing in canada
00:25:04
for us very important the patient feedback here's just a a few
00:25:10
statements ah patients have done in their start is like uh
00:25:15
i think i bit off is very useful in determining michael protecting
00:25:19
it's incredibly easy to use i think it's it's creamy handy
00:25:24
or a lot of patience i said at the at the beginning yeah so that was
00:25:28
a little bit on tour on safe but now i'm very pro city if
00:25:32
and uh one lady uh said it's absolutely amazing
00:25:37
that such tests are coming to the market
00:25:42
oh ah you can also find some more um into use and be and
00:25:49
and and and and statements with patients and nurses on you too
00:25:53
the summary
00:25:56
they think it leads to many benefits for the patients it
00:26:00
needs also to many event benefits to the physicians
00:26:04
ah and they think at the end therapies could be optimised and that just it immediately
00:26:13
the studies have to be down regulators have to be okay with this
00:26:17
we are not at the time being steal that to talk to
00:26:20
the size to better therapy will be adapted change and so on so
00:26:25
the patients is the patient is not allowed to do with
00:26:28
to to tease by himself but just we are we are
00:26:34
running start is to get the farmer companies that the b. b. c.
00:26:39
he can replace the code beef can in future how many minutes do we have
00:26:47
which one minute so i'd go very quickly
00:26:51
we have we have um ah
00:26:55
three different areas we want to develop for ah ah and t. i. b. talk to
00:27:01
for to ah applications that with two for two medical and paraplegic fields one is
00:27:08
that we want to integrate uh the the uh the
00:27:12
i. b. talk into it to order acts
00:27:15
of of of of for parties article universities i
00:27:19
folded explain this this is one project
00:27:23
so uh the puppet patient reported outcome is this is very
00:27:28
useful by such combinations and we can very strongly integrate
00:27:36
the second is
00:27:40
new diseases
00:27:43
therapy monitoring of antique enough trucks biological like h. it's very
00:27:47
it's very expensive very important to money toward we do
00:27:52
it now we have already test on that want to read it in serum people to bring these tests now
00:27:59
in capillary plop onto this platform this is called i built one
00:28:05
one and that's the last thing we are now planning
00:28:09
putting together a package we call it i could talk to it's to
00:28:12
see all the that the call is a fully integrated approach
00:28:16
so we'll we'll have smart phones at the patients be it be
00:28:19
like point of care either at doctors lactic small laboratories
00:28:23
uh we have a we have laboratory information systems and
00:28:27
we want all to integrate this one system
00:28:32
and at what what's missing here is the boom back and of course we want uh to have all the results
00:28:40
to get there and the men manage all all uh the things together in in in our back and
00:28:46
so summaries it think self monitoring patients element on gen general needs
00:28:54
for the health care professional at the quality of care for the chronic patient but
00:28:59
the quality of life for the payers improve costs improve care at lower cost
00:29:06
uh just in the current edition of the journal m. help our
00:29:11
system was discussed a little bit and blank wall these
00:29:15
it's an exciting time for the industry the rapid in your
00:29:19
game changing point in how we monitor injury patients
00:29:22
at the point of care so with these thank you
00:29:24
went hello from the human true thank you ah
00:29:34
trying to remote should not very interesting and very nice example of our
00:29:41
product be relaunched endures i the ration it's out now and ah
00:29:52
they're triangle doctor ration producer and you can't
00:29:57
afford for product or so around
00:30:02
you're almost a ready for launch launch bright but the wrong one question for eh
00:30:11
for doctor uh with rubber any questions before launch
00:30:19
oh please oh okay
00:30:23
the u. e. system that you put together is really very
00:30:26
interesting and actually we're going to question the ranch cues
00:30:31
the sample shoes did you preached on privacy and encryption that's right
00:30:37
obviously is appropriate for united states should maybe your is your it's obviously
00:30:42
not necessarily the keys for union underground or to watch retrenchment
00:30:47
how are you thinking about the distribution of those outside the educated
00:30:51
popular should remember all the problems that you mentioned into
00:30:55
watch the rock were remembered novice users problem but received krishna levels
00:31:01
or lines of the bribes you could charge was uh
00:31:04
let's say first we haven't in our clear goal was not to go into for a concrete
00:31:10
barracks in and doing a h. i. v. testing or this kind of test things
00:31:16
however we have been approached by the peel them feeling that gates foundation about a month
00:31:24
ago and they are very interested in i. b. dock and we are now
00:31:28
he's costing very openly and and and that it's very early
00:31:35
to to adapt the ideal from eighty four for their for their plans
00:31:40
uh to adopt it for for to make it much easier
00:31:45
uh be placed a date and integration maybe there will be in two three years
00:31:50
you will see a our concept bills will be applied in third world countries
00:31:59
how most probably yes well up but still still that the clinics are
00:32:05
not very well equipped so and do trooper homes were roswell quote
00:32:12
but the technology would allow that that that that that it's used
00:32:15
by e. by night quite naive people by by late uses
00:32:20
because uh it's all it's also use by and lets it by mail educated play may uses
00:32:28
i mention terrific switched rooms thank you
00:32:35
oh

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Conference program

Welcome Note
Gaëtan Cherix, Director - School of Engineering
26 Oct. 2017 · 10:08 a.m.
Welcome Note
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 10:15 a.m.
349 views
Point-of-care Diagnostics: what are the real needs of general practioners?
Nicolas Senn, PMU, UNIL
26 Oct. 2017 · 10:19 a.m.
Recent developments in microtechnologies for point-of-care testing
Philippe Renaud, EPFL
26 Oct. 2017 · 10:47 a.m.
GenePOC, a breakthrough solution in molecular point-of-care testing
Patrice Allibert, GenePOC
26 Oct. 2017 · 11:19 a.m.
Reglementary aspects ruling the reimbursement of laboratory analyses in the context of the compulsory health insurance
Michèle A. Fleury-Siegenthaler, Federal Office of Public Health
26 Oct. 2017 · 2:12 p.m.
114 views
Recent advances in non-invasive diagnostics
Samantha Paoletti, CSEM
26 Oct. 2017 · 3:53 p.m.
How nanofluidics bring diagnostics closer to the patient
Fabien Rebeaud, Abionic
26 Oct. 2017 · 4:17 p.m.
Keynote Session introduction
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 5:07 p.m.
Keynote session: Accessible Bioanalysis for the Developing World and the Point of Care
George M. Whitesides, Harvard University, Cambridge - USA
26 Oct. 2017 · 5:09 p.m.
126 views
Conclusions
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 6:25 p.m.

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