Ukuphumelela Okusha Ekuhlolweni Kwegazi Kwe-Early-Stage Prostate Cancer

I-Datar Cancer Genetics namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) inikeze i-'Breakthrough Device Designation' ukuze kuhlolwe igazi ukuze kutholwe umdlavuza wendlala yesinye. Lokhu ukuhlola kwesibili okuvela eNkampanini ethole i-Breakthrough Device Designation evela ku-US FDA. Ngonyaka odlule, ukuhlolwa kweNkampani kokutholwa komdlavuza webele kusenesikhathi kwaba ukuhlola kokuqala okunjalo ukuthola i-Breakthrough Device Designation.      

E-Europe, umdlavuza wendlala yesinye uhlobo lwesibili oluvame kakhulu lomdlavuza phakathi kwabesilisa lapho kutholakala khona izehlakalo ezilinganiselwa ku-500,000 kanye nokufa kwabantu abayizi-100,000 ngo-2022. Ukuhlolwa kungakhomba abantu okungenzeka ukuthi babe nomdlavuza ku-prostate futhi kusize ekuthathweni kwezinqumo zomtholampilo njengokuthi isidingo sokwenza i-biopsy ukuze kutholakale ukuxilongwa okuqinisekisiwe.

Ucwaningo lubonise ukuthi ukuhlolwa kungathola umdlavuza wendlala yesinye ngokunemba okuphezulu (>99%) ngaphandle kokuthola amanga. Ukuhlolwa kudinga igazi elingu-5 ml futhi kuboniswa kwabesilisa abaneminyaka yobudala engama-55-69 nge-serum PSA engu-3 ng/mL noma ngaphezulu. Ukuhlolwa kusekelwe ekutholweni kwe-prostate adenocarcinoma ethize I-Circulating Tumor Cells (CTCs) egazini.

“Igama ledivayisi eliphumelelayo liwukuqashelwa kwezinzuzo ezingaba khona zokuhlolwa esimweni somtholampilo njengoba kungasiza ukwehlisa inani lama-biopsies phakathi kwabantu abanezimo ezingezinhle ze-prostate futhi kungathuthukisa amazinga okutholwa kulabo abanomdlavuza wendlala yesinye. Ngobuchwepheshe bethu bokuceba nokuhlonza i-CTC, cishe abukho ubungozi bokutholwa kwamanga phakathi kwabantu abangenawo umdlavuza wendlala yesinye,” kusho uDkt Vineet Datta, uMqondisi Omkhulu weNkampani. Ukuhlolwa ngaphambilini kuke kwathola isitifiketi se-CE futhi sekuvele kutholakala e-Europe njenge-'Trublood-Prostate'. I-UK-NICE ngonyaka odlule ikhiphe i-MedTech Innovation Briefing eyachaza Ukuhlolwa njengokuthi 'Ukushintsha Kwegeyimu'. 

I-Breakthrough Device Designation inikezwa i-FDA ngamadivayisi abonisa amandla okuxilongwa okuphumelelayo kwezifo ezisongela ukuphila ezifana nomdlavuza. I-Breakthrough Devices Programme ihlose ukuhlinzeka iziguli nabahlinzeki bezempilo ngokufinyelela okufika ngesikhathi emishinini yezokwelapha enikezwe ukuqokwa okunjalo ngokubuyekezwa okubalulekile, ukuthuthukiswa okusheshayo nokuhlola.