Sabuwar Cigaban Farko Kan Gwajin Jini Kan Cutar Prostate Prostate

Datar Cancer Genetics a yau ta sanar da cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta ba da ‘Breakthrough Device Designation’ don gwajin jininta don gano kansar prostate a farkon matakin. Wannan shine gwaji na biyu daga Kamfanin da ya sami Na'urar Na'urar Breakthrough daga FDA ta Amurka. A shekarar da ta gabata, gwajin gano cutar kansar nono na Kamfanin ya zama irin wannan gwaji na farko da ya karɓi Na'urar Na'urar Breakthrough.      

A Turai, ciwon daji na prostate shine nau'in ciwon daji na biyu a tsakanin maza da aka gano kimanin mutane 500,000 da mutuwar 100,000 a cikin 2022. Gwajin na iya gano mutanen da suka fi kamuwa da ciwon daji a cikin prostate kuma yana taimakawa wajen yanke shawara na asibiti kamar su. Bukatar shan biopsy don tabbatar da ganewar asali.

Nazarin ya nuna cewa gwajin na iya gano ciwon daji na prostate a farkon matakin tare da daidaito mai girma (> 99%) ba tare da wata hujja ta ƙarya ba. Gwajin yana buƙatar jini na 5 ml kuma ana nuna shi ga maza masu shekaru 55-69 tare da maganin PSA na 3 ng/mL ko mafi girma. Gwajin ya dogara ne akan gano prostate adenocarcinoma takamaiman Kwayoyin Ciwon Tumor (CTCs) a cikin jini.

“Nadin na’urar da aka yi nasara shine sanin yuwuwar fa’idar gwaji a cikin asibiti saboda yana iya taimakawa rage adadin ƙwayoyin cuta a tsakanin mutanen da ke da yanayin prostate kuma yana iya haɓaka ƙimar ganowa a tsakanin waɗanda ke da cutar sankara ta prostate. Tare da fasahar haɓakawar CTC ta mallakarmu da fasahar ganowa, kusan babu haɗarin ƙirƙira ƙarya tsakanin mutanen da ba su da cutar sankara ta prostate,” in ji Dokta Vineet Datta, Babban Darakta na Kamfanin. Gwajin a baya ya sami takardar shedar CE kuma an riga an samu shi a Turai a matsayin 'Trublood-Prostate'. UK-NICE bara ta ba da Briefing Innovation na MedTech wanda ya bayyana Gwajin a matsayin 'Canjin Wasan'. 

The Breakthrough Device Design an ba da ita ta FDA don na'urorin da ke nuna yuwuwar samun ingantaccen bincike na cututtukan da ke barazanar rayuwa kamar kansa. Shirin na'urorin Breakthrough yayi niyyar samarwa marasa lafiya da ma'aikatan kiwon lafiya damar samun na'urorin likitanci akan lokaci waɗanda aka ba da irin wannan nadi ta hanyar bita da aka ba da fifiko, haɓaka haɓakawa da ƙima.