Izingozi Ezihlotshaniswa Nokuhlolwa Kokuhlolwa Kwangaphambi Kokubeletha Okungahlaseli

A BAMBA MahhalaRelease 3 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

Namuhla, i-US Food and Drug Administration ixwayisa umphakathi ngengozi yemiphumela engamanga, ukusetshenziswa okungalungile kanye nokutolikwa okungalungile kwemiphumela ngokuhlolwa kwe-non-invasive prenatal screening (NIPS), okubuye kubizwe ngokuthi ukuhlola kwe-DNA yamahhala noma ukuhlola okungahlanyisi ngaphambi kokubeletha. (NIPT). Lokhu kuhlola kubheka izimpawu zokungajwayelekile kofuzo kumntwana ngokuhlola isampula legazi kumuntu okhulelwe. Uma kubhekwa ukwanda kokusetshenziswa kwalezi zivivinyo nemibiko yakamuva yabezindaba, i-FDA inikeza lolu lwazi ukuze kufundiswe iziguli nabahlinzeki bezempilo kanye nokusiza ukunciphisa ukusetshenziswa okungafanele kokuhlolwa kwe-NIPS.

"Nakuba ukuhlolwa kokuhlolwa kwezakhi zofuzo okungezona okuhlaselayo kusetshenziswa kabanzi namuhla, lezi zivivinyo azikabuyekezwa yi-FDA futhi zingase zenze izimangalo mayelana nokusebenza kwazo nokusetshenziswa kwazo okungasekelwe kusayensi yomsindo," kusho uJeff Shuren, MD, JD. umqondisi we-FDA's Center for Devices and Radiological Health. “Ngaphandle kokuqonda kahle ukuthi lezi zivivinyo kufanele zisetshenziswe kanjani, abantu bangase benze izinqumo zokunakekelwa kwezempilo ezingafanele mayelana nokukhulelwa kwabo. Sinxusa kakhulu iziguli ukuthi zixoxe ngezinzuzo nezingozi zalokhu kuhlolwa nomeluleki wezakhi zofuzo noma omunye umhlinzeki wezempilo ngaphambi kokuthatha izinqumo ezisekelwe emiphumeleni yalokhu kuhlolwa.”

Ukuhlolwa kwe-NIPS kunganikeza ulwazi mayelana nokuthi kungenzeka yini ukuthi ingane izalwe inesimo esibucayi sempilo. Kodwa-ke, izivivinyo ze-NIP ziyizivivinyo zokuhlola - hhayi izivivinyo zokuxilonga. Banikeza kuphela ulwazi olumayelana nengcuphe yokuthi umbungu ungaba nenkinga yofuzo, futhi kungase kudingeke ukuhlolwa okwengeziwe ukuze kuqinisekiswe ukuthi umbungu uyathinteka yini noma cha.

Ukungajwayelekile kofuzo kungase kubangelwe i-chromosome engekho noma ikhophi eyengeziwe ye-chromosome, eyaziwa ngokuthi i-aneuploidy, ucezu oluncane olungekho ku-chromosome olubizwa ngokuthi i-microdeletion, noma ucezu olwengeziwe lwe-chromosome olubizwa ngokuthi ukuphindaphinda. Lokhu kungahambi kahle kwezakhi zofuzo kungabangela izimo zempilo ezimbi kakhulu. Izimo ezibangelwa i-chromosome engekho noma ikhophi eyengeziwe ye-chromosome zivame kakhulu futhi kungase kube lula ukutholakala, njenge-Down syndrome, engabangela izinselele ezingokomzimba nezingokwengqondo. Ingxenye yechromosome engekho noma eyengeziwe ingase ibangele izimo ezingavamile, njenge-DiGeorge syndrome, engabangela ukukhubazeka kwenhliziyo, ubunzima bokudla, izinkinga zamasosha omzimba kanye nobunzima bokufunda.

Zonke izivivinyo ze-NIP ezimakethe namuhla zinikezwa njengezivivinyo ezithuthukisiwe zaselabhorethri (LDTs). Ama-LDT amaningi, okuhlanganisa nokuhlolwa kwe-NIPS, anikezwa ngaphandle kokubuyekezwa yi-FDA. Nakuba ama-LDT kungamathuluzi ezokwelapha ngaphansi koMthetho Wezokudla, Izidakamizwa, Nezimonyo, i-FDA ibe nenqubomgomo evamile yomthetho womthetho kuma-LDT amaningi kusukela kwashaywa Izichibiyelo Zedivayisi Yezokwelapha ngo-1976. Lokho kusho ukuthi i-FDA ngokuvamile ayisebenzisi izimfuneko zokulawula ezisebenzayo. kuma-LDT amaningi. I-FDA iyaqhubeka nokusebenza neCongress mayelana nomthetho ukuze kusungulwe uhlaka lwesimanje lokulawula kukho konke ukuhlola, okuhlanganisa nama-LDT.

Amalabhorethri amaningi anikeza lezi zivivinyo akhangisa ukuhlola kwawo ngokuthi “okwethenjelwa” futhi “okunembe kakhulu,” okunikeza “ukuthula kwengqondo” ezigulini. I-FDA ikhathazekile ngokuthi lezi zimangalo zingase zingasekelwa ubufakazi obuzwakalayo besayensi. Yize lezi zilabhorethri zithi ukuhlolwa kwazo kunembe kakhulu, kunemikhawulo ngenxa yokungatholakali kweminye yemibandela efakwe ekuhlolweni. Isibonelo, lapho uhlolelwa isimo esingavamile kakhulu, umphumela wokuhlolwa oqondile ungase ube maningi amathuba okuba ube ne-positive okungelona iqiniso, futhi umbungu ungase ungathinteki ngempela. Kwezinye izimo, umphumela wokuhlolwa oqondile ungathola ngokunembile ukungavamile kwe-chromosomal, kodwa lokho kungavamile kukhona ku-placenta hhayi ku-fetus, okungenzeka kube nempilo.

Iziguli nabahlinzeki bokunakekelwa kwezempilo kufanele baqaphele ubungozi nemikhawulo yokusebenzisa lezi zivivinyo zokuhlolwa kofuzo ngaphambi kokubeletha nokuthi akufanele zisetshenziswe zodwa ukuze kuhlonzwe ukungajwayelekile kwe-chromosomal (ufuzo). Kodwa-ke, i-FDA iyayazi imibiko yokuthi iziguli nabahlinzeki bezempilo benze izinqumo zokunakekelwa kwezempilo ezibucayi ngokusekelwe emiphumeleni yalezi zivivinyo zokuhlola ngaphandle kokuhlolwa okwengeziwe kokuqinisekisa. Abantu abakhulelwe baye baqeda ukukhulelwa ngokusekelwe emiphumeleni yokuhlolwa kofuzo kwangaphambi kokubeletha iyodwa, ngaphandle kokuqonda imikhawulo yokuhlolwa kokuhlolwa nokuthi umbungu ungase ungabi nakho okungavamile kofuzo okuhlonzwe ukuhlolwa kokuhlolwa. 

I-FDA incoma ukuthi iziguli nabahlinzeki bezempilo baxoxe ngezinzuzo nezingozi zakho konke ukuhlolwa kofuzo kwangaphambi kokubeletha, okuhlanganisa nokuhlolwa kwe-NIPS, nomeluleki wezakhi zofuzo noma omunye umhlinzeki wezempilo ngaphambi kokucabangela lokho kuhlola noma ukwenza noma yiziphi izinqumo mayelana nokukhulelwa kwabo. Sicela ubheke ukuxhumana kwezokuphepha okuxhunywe ngezansi ukuze uthole uhlu olugcwele lwezincomo zeziguli nabahlinzeki bezempilo.

I-FDA izoqhubeka nokuqapha ngokucophelela izindaba zokuphepha mayelana nokusetshenziswa kokuhlolwa kwe-NIP futhi izibophezele ekuvikeleni impilo yomphakathi.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

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