{"id":1242,"date":"2020-03-06T09:13:58","date_gmt":"2020-03-06T08:13:58","guid":{"rendered":"https:\/\/invent.bio\/?page_id=1242"},"modified":"2021-02-23T15:04:19","modified_gmt":"2021-02-23T14:04:19","slug":"ivd-development","status":"publish","type":"page","link":"https:\/\/inventdiagnostica.de\/en\/products\/services\/ivd-development\/","title":{"rendered":"IVD Devel\u00adop\u00adment"},"content":{"rendered":"\t\t
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Our val\u00adue propo\u00adsi\u00adtion: Qual\u00adi\u00adty & Inno\u00adva\u00adtion<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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With our research & devel\u00adop\u00adment depart\u00adment we con\u00adtribute to the devel\u00adop\u00adment of high-qual\u00adi\u00adty in-vit\u00adro diag\u00adnos\u00adtics and sup\u00adport our part\u00adners with prod\u00aducts and qual\u00adi\u00adfied exper\u00adtise.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Cross-plat\u00adform test sys\u00adtems & con\u00adtrols<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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We devel\u00adop in-vit\u00adro diag\u00adnos\u00adtics (IVD) in form of test sys\u00adtems and con\u00adtrols with CE mark\u00ading. Our work is plat\u00adform-inde\u00adpen\u00addent, com\u00adpris\u00ading ELISA kits, rapid tests, and auto\u00admat\u00aded sys\u00adtems.<\/p>

In addi\u00adtion to our own devel\u00adop\u00adments, we coop\u00ader\u00adate with part\u00adners from sci\u00adence and phar\u00adma\u00adceu\u00adti\u00adcal & diag\u00adnos\u00adtic indus\u00adtry in both fields, human and vet\u00aderi\u00adnary.<\/p>

For us, the qual\u00adi\u00adty of a devel\u00adop\u00adment is sub\u00adstan\u00adtial\u00adly defined by the qual\u00adi\u00adty of the used sam\u00adples which is reflect\u00aded in our com\u00adpe\u00adtence in the field of pro\u00advid\u00ading human biospec\u00adi\u00admens<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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From Autoim\u00admu\u00adni\u00adty to Oncol\u00ado\u00adgy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Our coop\u00ader\u00ada\u00adtion with Diag\u00adnos\u00adtikNet BB<\/strong><\/a> enables us to han\u00addle the com\u00adplete IVD prod\u00aduct cycle<\/strong> from fea\u00adsi\u00adbil\u00adi\u00adty study to CE-marked.<\/p>

There\u00adfore, we could already real\u00adize numer\u00adous projects which are applied in rou\u00adtine diag\u00adnos\u00adtics as well as in ther\u00ada\u00adpy deci\u00adsions<\/strong>, e.g. autoim\u00admune dis\u00adeases<\/strong>, the deter\u00admi\u00adna\u00adtion of small mol\u00ade\u00adcules, and mon\u00adi\u00adtor\u00ading in the field of nov\u00adel food<\/strong> \/ nutri\u00adtion\u00adals.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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EQAS & Kit Exter\u00adnal Con\u00adtrols<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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On the one hand, we sup\u00adport many Euro\u00adpean EQAS providers with con\u00adtrols in order to ensure inter-lab\u00ado\u00adra\u00adto\u00adry<\/strong> qual\u00adi\u00adty con\u00adtrol, while on the oth\u00ader hand, we offer the devel\u00adop\u00adment and pro\u00adduc\u00adtion of kit-exter\u00adnal and man\u00adu\u00adfac\u00adtur\u00ader-inde\u00adpen\u00addent con\u00adtrols for the use in lab\u00ado\u00adra\u00adto\u00adry rou\u00adtine<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Immunoas\u00adsays \u2013 From PoC to Auto\u00admat\u00aded Sys\u00adtems<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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In the field of test sys\u00adtems we are espe\u00adcial\u00adly focused on immunoas\u00adsays. These dif\u00adfer, for exam\u00adple, from chem\u00adi\u00adcal reac\u00adtion meth\u00adods such as the Jaf\u00adf\u00e9 reac\u00adtion for the detec\u00adtion of cre\u00ada\u00adti\u00adnine or the mea\u00adsure\u00adment of the ery\u00adthro\u00adcyte sed\u00adi\u00admen\u00adta\u00adtion rate.<\/p>

A typ\u00adi\u00adcal rep\u00adre\u00adsen\u00adta\u00adtive of immunoas\u00adsays is the ELISA<\/strong> (Enzyme-linked Immunosor\u00adbent Assay) which usu\u00adal\u00adly con\u00adsists of two anti\u00adbod\u00adies that bind an anti\u00adgen in the sam\u00adple by form\u00ading a sand\u00adwich com\u00adplex and enabling its quan\u00adtifi\u00adca\u00adtion by an enzy\u00admat\u00adic colour reac\u00adtion.<\/p>

In con\u00adtrast to this, there is also the pos\u00adsi\u00adbil\u00adi\u00adty of a com\u00adpet\u00adi\u00adtive test set\u00adup. Instead of anti\u00adbod\u00adies also anti\u00adgens can be used to detect anti\u00adbod\u00adies in the sam\u00adple. For this detec\u00adtion are used, among oth\u00aders, enzy\u00admat\u00adic-col\u00adori\u00admet\u00adric<\/strong> label\u00ading with lumi\u00adnes\u00adcence<\/strong>, latex<\/strong> or gold<\/strong> par\u00adti\u00adcles.<\/p>

In gen\u00ader\u00adal prac\u00adtice of auto\u00admat\u00aded sys\u00adtems the man\u00adu\u00adal steps of a typ\u00adi\u00adcal ELISA are tak\u00aden over by an auto\u00admat\u00aded pipet\u00adting<\/strong> sys\u00adtem so that the analy\u00adsis is per\u00adformed auto\u00admat\u00adi\u00adcal\u00adly. These auto\u00admat\u00aded sys\u00adtems are main\u00adly used in med\u00adical diag\u00adnos\u00adtic rou\u00adtine lab\u00ado\u00adra\u00adto\u00adries to process a high\u00ader num\u00adber of patient sam\u00adples.<\/p>

For diag\u00adnos\u00adtic para\u00adme\u00adters, where the time between sam\u00adple col\u00adlec\u00adtion and result is cru\u00adcial for the patient, rapid tests<\/strong> are used (Point of Care<\/strong> (PoC) tests), e.g. in form of lat\u00ader\u00adal<\/strong> or ver\u00adti\u00adcal<\/strong> flow sys\u00adtems. Immunoas\u00adsay rapid tests have a sim\u00adi\u00adlar struc\u00adture to ELISA but typ\u00adi\u00adcal\u00adly use col\u00adloidal gold for label\u00ading to allow visu\u00adal eval\u00adu\u00ada\u00adtion.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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The com\u00adplete Prod\u00aduct Cycle of an IVD<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The devel\u00adop\u00adment of an IVD starts with the project idea and assess\u00adment <\/strong>includ\u00ading the require\u00adments pro\u00adfile<\/strong> fol\u00adlowed by the fea\u00adsi\u00adbil\u00adi\u00adty<\/strong> study. In this study it is exam\u00adined whether the require\u00adments can be gen\u00ader\u00adal\u00adly ful\u00adfilled, for exam\u00adple, whether the mea\u00adsur\u00ading range can be achieved with the select\u00aded raw mate\u00adri\u00adals and test sys\u00adtem. Sub\u00adse\u00adquent\u00adly, the now rough\u00adly defined basic con\u00addi\u00adtions are fine-tuned in the actu\u00adal prod\u00aduct devel\u00adop\u00adment and opti\u00admiza\u00adtion<\/strong> phase.<\/p>

In trans\u00adfer-to-pro\u00adduc\u00adtion<\/strong>, the man\u00adu\u00adfac\u00adtur\u00ading process is scaled up<\/strong>. Fur\u00adther\u00admore, the repeata\u00adbil\u00adi\u00adty is ver\u00adi\u00adfied so that the final prod\u00aduct is ready for series pro\u00adduc\u00adtion<\/strong> and the process is reg\u00adu\u00adlat\u00aded, con\u00adtrolled, and auditable.<\/p>

In the final per\u00adfor\u00admance eval\u00adu\u00ada\u00adtion<\/strong> test con\u00adfor\u00admi\u00adty with the ini\u00adtial\u00adly defined require\u00adments is assessed, e.g. in terms of pre\u00adci\u00adsion, homo\u00adgene\u00adity, sen\u00adsi\u00adtiv\u00adi\u00adty, recov\u00adery, and clin\u00adi\u00adcal per\u00adfor\u00admance. These data includ\u00aded in the tech\u00adni\u00adcal doc\u00adu\u00admen\u00adta\u00adtion<\/strong>, which is the basic require\u00adment for approval to obtain the CE label and launch <\/strong>an IVD on the mar\u00adket. In order to eval\u00adu\u00adate the qual\u00adi\u00adty of the prod\u00aduct, after mar\u00adket place\u00adment, post-mar\u00adket sur\u00adveil\u00adlance <\/strong>is fol\u00adlow\u00ading after\u00adwards. The find\u00adings may result in adjust\u00adments of the prod\u00aduct so that the prod\u00aduct cycle starts all over again.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Human & Vet\u00aderi\u00adnary Diag\u00adnos\u00adtics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The prin\u00adci\u00adple of a pre\u00adcise and ear\u00adly diag\u00adno\u00adsis,<\/strong> as the best pre\u00adreq\u00adui\u00adsite for a suc\u00adcess\u00adful ther\u00ada\u00adpy,<\/strong> exists for a long time and has not lost its rel\u00ade\u00advance in view of demo\u00adgraph\u00adic change, the increas\u00ading num\u00adber of chron\u00adic dis\u00adeases, and can\u00adcer diag\u00adnoses.<\/p>

Thy\u00adroid dis\u00adeases <\/strong>like Hashimo\u00adto and Graves\u2019 dis\u00adease are autoim\u00admune dis\u00adeases in which the body pro\u00adduces anti\u00adbod\u00adies against the body\u2019s own pro\u00adteins. These detect\u00aded autoan\u00adti\u00adbod\u00adies can be used for diag\u00adno\u00adsis.<\/p>

Anoth\u00ader autoim\u00admune dis\u00adease is rheuma\u00adtoid arthri\u00adtis<\/strong>. For the diag\u00adno\u00adsis well-known bio\u00admark\u00aders are used such as rheuma\u00adtoid fac\u00adtors and anti\u00adbod\u00adies against cyclic cit\u00adrul\u00adli\u00adnat\u00aded pep\u00adtides. Since there is no cure for this chron\u00adic dis\u00adease, sci\u00aden\u00adtists are still search\u00ading for new bio\u00admark\u00aders that allow ear\u00adly diag\u00adno\u00adsis.<\/p>

Many research approach\u00ades in the field of immuno-oncol\u00ado\u00adgy<\/strong> are also con\u00adcerned with the find\u00ading of new pos\u00adsi\u00adbil\u00adi\u00adties for diag\u00adno\u00adsis and prog\u00adno\u00adsis as well as ther\u00ada\u00adpy mon\u00adi\u00adtor\u00ading of the dis\u00adease.<\/p>

In autoim\u00admu\u00adni\u00adty the focus is on the mea\u00adsure\u00adment of autoan\u00adti\u00adbod\u00adies, where\u00adas in oth\u00ader dis\u00adeases small mol\u00ade\u00adcules are detect\u00aded. In case of degen\u00ader\u00ada\u00adtive dis\u00adeases, for exam\u00adple osteoarthri\u00adtis<\/strong>, the degrad\u00aded frag\u00adments can be used for diag\u00adnos\u00adtics. In some cas\u00ades, the most sen\u00adsi\u00adtive bio\u00admark\u00aders are not obvi\u00adous\u00adly relat\u00aded to the dis\u00adease, a well-known exam\u00adple is pro\u00adcal\u00adci\u00adtonin in sep\u00adsis<\/strong>.<\/p>

Nov\u00adel food, nutraceu\u00adti\u00adcals<\/strong>, func\u00adtion\u00adal food, etc. are more and more impor\u00adtant in the health sec\u00adtor in addi\u00adtion to clas\u00adsi\u00adcal diag\u00adnos\u00adtics and ther\u00ada\u00adpy for known and new dis\u00adeases. These foods include pri\u00admar\u00adi\u00adly health-pro\u00admot\u00ading prop\u00ader\u00adties such as chia seeds, noni juice, and ste\u00advia.<\/p>

We devel\u00adoped tests and con\u00adtrols for sev\u00ader\u00adal of the list\u00aded top\u00adics above and we are in active coop\u00ader\u00ada\u00adtion with sci\u00adence and indus\u00adtry to con\u00adtribute to high-qual\u00adi\u00adty diag\u00adnos\u00adtic. For iden\u00adti\u00adfi\u00adca\u00adtion of new bio\u00admark\u00aders we also work with engine the bio\u00admark\u00ader com\u00adpa\u00adny<\/strong><\/a>. Com\u00adbined with their tech\u00adnol\u00ado\u00adgy over 100.000 poten\u00adtial anti\u00adgens are ana\u00adlyz\u00adable in one step.<\/p>

In the vet\u00aderi\u00adnary<\/strong> sec\u00adtor the same prin\u00adci\u00adples apply as in human diag\u00adnos\u00adtics & med\u00adi\u00adcine, and there\u00adfore we are expand\u00ading our prod\u00aduct port\u00adfo\u00adlio to biospec\u00adi\u00admens of ani\u00admal ori\u00adgin and col\u00adlab\u00ado\u00adrate with part\u00adners from the Diag\u00adnos\u00adtikNet <\/strong>BB on projects for bio\u00admark\u00ader-based osteoarthro\u00adsis diag\u00adnos\u00adtics in dogs<\/strong> & hors\u00ades<\/strong> as well as on the devel\u00adop\u00adment of vet\u00aderi\u00adnary con\u00adtrols<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"engine\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Our val\u00adue propo\u00adsi\u00adtion: Qual\u00adi\u00adty & Inno\u00adva\u00adtion With our research & devel\u00adop\u00adment depart\u00adment we con\u00adtribute to the devel\u00adop\u00adment of high-qual\u00adi\u00ad\u00adty in-vit\u00adro diag\u00adnos\u00adtics and sup\u00adport our part\u00adners with prod\u00aducts and qual\u00adi\u00adfied exper\u00adtise. Cross-plat\u00ad\u00adform test sys\u00adtems & con\u00adtrols We devel\u00adop in-vit\u00adro diag\u00adnos\u00adtics (IVD) in form of test sys\u00adtems and con\u00adtrols with CE mark\u00ading. Our work is plat\u00ad\u00adform-inde\u00adpen\u00ad\u00addent, com\u00adpris\u00ading \u2026 <\/p>\n

Con\u00adtin\u00adue read\u00ading \u201cIVD Devel\u00adop\u00adment\u201d<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":740,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"wp_typography_post_enhancements_disabled":false,"footnotes":""},"class_list":["post-1242","page","type-page","status-publish","hentry"],"yoast_head":"\nIVD Development - in.vent Diagnostica<\/title>\n<meta name=\"description\" content=\"The prerequisite for successful product development in diagnostics is the availability of defined patient samples with reliable clinical data and the ...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/inventdiagnostica.de\/en\/products\/services\/ivd-development\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IVD Development - 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