I-Datar Cancer Genetics namhlanje ibhengeze ukuba i-US Food and Drug Administration (FDA) inike i-'Breakthrough Device Designation' yovavanyo lwegazi lokubona umhlaza we-prostate kwasekuqaleni. Olu luvavanyo lwesibini oluvela kwiNkampani efumene ukutyunjwa kwesiXhobo sokuQala kwi-US FDA. Kunyaka ophelileyo, iNkampani yovavanyo lokufumana umhlaza webele kwangoko yaba lolokuqala uvavanyo lokufumana ukuchongwa kwesiXhobo seBreakthrough.
EYurophu, umhlaza wedlala lobudoda lolona hlobo lwesibini luxhaphakileyo lomhlaza phakathi kwamadoda ngokuchongwa kweemeko eziqikelelwa kwi-500,000 kunye ne-100,000 yokusweleka ngo-2022. Isidingo sokwenza i-biopsy ukwenzela ukuxilongwa okuqinisekisiweyo.
Uphononongo lubonise ukuba uvavanyo lunokufumanisa umhlaza we-prostate wesigaba sokuqala ngokuchaneka okuphezulu (> 99%) ngaphandle kobuxoki. Uvavanyo ludinga igazi le-5 ml kwaye luboniswa kumadoda aneminyaka engama-55-69 iminyaka kunye ne-serum ye-PSA ye-3 ng / mL okanye ngaphezulu. Uvavanyo lusekelwe ekubhaqweni kwe-prostate adenocarcinoma ecacileyo ye-Circulating Tumor Cells (CTCs) egazini.
"Ukwenziwa kwesixhobo esiyimpumelelo kukuqondwa kweenzuzo ezinokubakho zovavanyo kwimeko yeklinikhi njengoko kunokunceda ukunciphisa inani le-biopsies phakathi kwabantu abaneemeko ezintle ze-prostate kwaye kunokuphucula amazinga okubona kwabo banomhlaza wesinyi. Ngobunini bethu be-CTC-yokutyebisa kunye neteknoloji yokufumanisa, akukho mngcipheko wezinto ezingeyonyani phakathi kwabantu abangenawo umhlaza wedlala lesinyi,” utshilo uGqr Vineet Datta, uMlawuli oyiNtloko weNkampani. Uvavanyo sele lufumene isatifikethi se-CE ngaphambili kwaye sele lufumaneka eYurophu njenge-'Trublood-Prostate'. I-UK-NICE kunyaka ophelileyo ikhuphe i-MedTech Innovation Briefing echaza uVavanyo njenge 'Game Changer'.
Ukutyunjwa kweSixhobo sokuPhuma kunikwe yi-FDA kwizixhobo ezibonisa amandla okuxilongwa ngokufanelekileyo kwezifo ezisongela ubomi ezifana nomhlaza. Inkqubo yeZixhobo zokuPhucula ijolise ekuboneleleni izigulane kunye nababoneleli bezempilo ngokufikelela kwangethuba kwizixhobo zonyango ezinikwe ukutyunjwa okunje ngophononongo oluphambili, uphuhliso olukhawulezileyo kunye novavanyo.
