Datar Cancer Genetics lero yalengeza kuti US Food and Drug Administration (FDA) yapereka 'Breakthrough Device Designation' kuti ayese magazi ake kuti azindikire khansa ya prostate yoyambirira. Awa ndi mayeso achiwiri kuchokera ku Kampani yomwe yalandira Kusankhidwa kwa Chipangizo Chochokera ku US FDA. Chaka chatha, kuyezetsa koyambilira kwa kampani ya khansa ya m'mawere kunakhala kuyesa koyamba kotereku kulandira Kusankhidwa Kwachida cha Breakthrough.
Ku Europe, khansa ya prostate ndi mtundu wachiwiri wa khansa yamtundu wachiwiri pakati pa amuna omwe apezeka kuti ali ndi milandu 500,000 ndi kufa 100,000 mu 2022. kufunikira kochitidwa ndi biopsy kuti mudziwe zotsimikizika.
Kafukufuku wasonyeza kuti kuyezetsa kumatha kuzindikira khansa ya prostate yoyambilira molondola kwambiri (> 99%) popanda zonena zabodza. Kuyezetsa kumafuna magazi a 5 ml ndipo kumasonyezedwa kwa amuna azaka zapakati pa 55-69 ndi seramu PSA ya 3 ng/mL kapena kupitirira apo. Kuyezetsako kumatengera kuzindikira kwa prostate adenocarcinoma yeniyeni yotchedwa Circulating Tumor Cells (CTCs) m'magazi.
"Kudziwika kwa chipangizochi ndikuzindikira ubwino woyezetsa kuchipatala chifukwa kungathandize kuchepetsa chiwerengero cha ma biopsies pakati pa anthu omwe ali ndi vuto la prostate komanso kungathandize kuti anthu omwe ali ndi khansa ya prostate adziwike. Ndi ukadaulo wathu wa CTC wolemeretsa ndi kuzindikira, palibe chiwopsezo chabodza pakati pa anthu omwe alibe khansa ya prostate,” atero Dr Vineet Datta, Executive Director wa Company. Mayesowa adalandirapo chiphaso cha CE ndipo akupezeka kale ku Europe ngati 'Trublood-Prostate'. UK-NICE chaka chatha idapereka MedTech Innovation Briefing yomwe idafotokoza Mayeso ngati 'Game Changer'.
The Breakthrough Device Designation imaperekedwa ndi FDA pazida zomwe zimawonetsa kuthekera kozindikiritsa bwino matenda owopsa monga khansa. Pulogalamu ya Breakthrough Devices ikufuna kupatsa odwala ndi opereka chithandizo chamankhwala mwayi wopeza zida zamankhwala zomwe zimaperekedwa munthawi yake ndikuwunika koyambirira, chitukuko chofulumira komanso kuwunika.
