Laboratory-developed test

Teskuyaaji peewnaaɗi e laboratuwaaruuji (LDT) ko denndaangal ƴeewndorɗe (IVDs) peewnaaɗe, peewnaaɗe, kuutorteeɗe e nder laboratuwaar gooto. Ɓe kuutortee ko e ƴeewndorɗe safaara ceertuɗe e kuutorɗe wiɗtooji, ina ndokka nafooje e nder ɓuuɓri e ƴellitde kesam-hesaagu e fannu ƴeewndorɗe.

 "Test ƴellitaaɗo e laboratuwaar" ko helmere huutorteende ngam siftinde won e fannuuji ƴeewndo in vitro (IVDs) ɗi, e nder U.S., ko adii fof ina njuɓɓinee e les porogaraam waylude laboratuwaaruuji safaara. 

 Leyɗeele dentuɗe Amerik 
To leyɗeele dentuɗe Amerik, fedde toppitiinde ko fayti e nguura e leɗɗe (FDA) hollitii wonde, so tawii ɗeeɗoo jarribooje ina mbaawi wonde kaɓirɗe safaara, ɗeeɗoo geɗe ina mbaawi naatde e luumo hee tawa ko e dow yamiroore fedde nde. E hitaande 2014, FDA hollitii wonde maa fuɗɗo reende won e LDT. Kono, e ko ɓuri teeŋtude, nde waɗaani noon, haa e lewru abriil 2019.

Nde tawnoo LDTs ​​ɗaɓɓaani laaɓal FDA 510(k) ɗaɓɓaangal jarribooji goɗɗi ngam anndude ñawu nguu, ko ɗum waɗi luulndiiɓe ɓee njiyri ɗum ko no loowdi kuule.Darnde-to-jaagorgal

Testuuji direct-to-consumer ina njuɓɓinee no kuutorɗe safaara nii, hay so tawii noon FDA ƴeewtaaki ɗi..

Teskuyaaji taariindi 23andMe direct-to-consumer ina ndokkee e fuɗɗoode ko LDTs, kono FDA luulndii ɗum, dooli sosiyetee oo yoɓde teskuyaaji ɗii ngam jaɓeede wonde kaɓirgal safaara class II..

 Sosiyeteeji 
Sosiyeteeji keewɗi ina ndokka jarribooji baɗaaɗi e laboratuwaar.

Sosiyeteeji keewɗi ina ngondi e ƴellitgol kuutorɗe jarribooje peewnaaɗe e laboratuwaaruuji, ina jeyaa heen Sosiyeteeji Adaptive Bioteknoloji, Quest Diagnostics, Roche, e Illumina.

 Yiyngo luumo 
Lugge winndereeje ngam jarribooji baɗaaɗi e laboratuwaaruuji (LDT) ina ɓeydoo mawnude, sibu ina ɗaminaa maa ɗum won 4582,6 miliyoŋ dolaar Amerik e hitaande 2030, tawi ko 3518,7 miliyoŋ dolaar Amerik e hitaande 2023 (CAGR ko 3,8%). Ngaal ɓeydagol ina addana ɗum yahrude yeeso e ƴeewndorɗe taariindi, ɓeydagol ɗaɓɓaande safaara keeriiɗo, e yaajde jokkondire e fannuuji cellal e ƴeewndorɗe.

 Tuugnorgal