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.[1]
"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.[2]
[taƴto | taƴto ɗaɗi wiki]Leyɗeele dentuɗe Amerik
[taƴto | taƴto ɗaɗi wiki]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.[3][4]
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..[5]
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.[6][7].[8]
Sosiyeteeji
[taƴto | taƴto ɗaɗi wiki]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
[taƴto | taƴto ɗaɗi wiki]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
[taƴto | taƴto ɗaɗi wiki]- ↑ "Laboratory Developed Testing Market to Reach $4582.6 Million" (in Engeleere). 2024-05-23. Retrieved 2024-05-23.
- ↑ "CLIA Overview" (in Engeleere). CMS. 11 April 2018.
- ↑ Yarbrough, Knobbe Martens-Daniel K.; Fuller, Michael (19 April 2017). "FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics | Lexology" (in Engeleere). Retrieved 2018-12-02.
- ↑ "23andMe Warning Letter Climaxes 7-Year Dilemma Over Lab-Developed Tests". MDDI Online (in Engeleere). 2014-01-14. Retrieved 2018-12-02.
- ↑ Health, Center for Devices and Radiological. "In Vitro Diagnostics - Direct-to-Consumer Tests". www.fda.gov (in Engeleere). Archived from the original on December 6, 2018. Retrieved 2018-12-02.
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs named:0 - ↑ "Laboratory Developed Tests". FDA (in Engeleere). 26 March 2018. Archived from the original on January 14, 2017.
- ↑ "Oversight Of Laboratory-Developed Tests" (PDF). CAP FAQs, Topic: Laboratory-Developed Tests. College of American Pathologists. 2 April 2019. Archived from the original (PDF) on 21 May 2019. Retrieved 15 December 2022.