Ua hoʻolaha ʻo Datar Cancer Genetics i kēia lā ua hāʻawi ka US Food and Drug Administration (FDA) i ka 'Breakthrough Device Designation' no kāna hoʻāʻo koko e ʻike i ka maʻi prostate mua. ʻO kēia ka lua o ka hoʻokolohua mai ka Hui i loaʻa i ka Breakthrough Device Designation mai ka US FDA. I ka makahiki i hala aku nei, ua lilo ka ho'āʻo ʻike maʻi maʻi umauma mua o ka Hui i ka hoʻāʻo mua e loaʻa ai ka Breakthrough Device Designation.
Ma ʻEulopa, ʻo ka maʻi maʻi prostate ka lua o ka maʻi maʻi maʻamau i waena o nā kāne me ka ʻike ʻana i kahi maʻi 500,000 a me 100,000 mau make i 2022. Hiki i ka hoʻāʻo ke ʻike i nā poʻe i ʻoi aku ka nui o ka loaʻa ʻana o ka maʻi maʻi i loko o ka prostate a kōkua i ka hoʻoholo ʻana e like me ka pono e hana i kahi biopsy no ka hōʻoia hōʻoia.
Ua hōʻike ʻia nā haʻawina e hiki ke ʻike i ka hoʻāʻo ʻana i ka maʻi prostate mua me ka pololei kiʻekiʻe (> 99%) me ka ʻole o nā hopena maikaʻi ʻole. Pono ka ho'āʻo i 5 ml koko a hōʻike ʻia no nā kāne o ka makahiki 55-69 mau makahiki me ka serum PSA o 3 ng/mL a i ʻole. Hoʻokumu ʻia ka hoʻāʻo ma ka ʻike ʻana o ka prostate adenocarcinoma kikoʻī Circulating Tumor Cells (CTCs) i loko o ke koko.
"ʻO ka hoʻohālikelike ʻana i ka mea hana hoʻokūkū he ʻike ia i nā pono kūpono o ka hoʻāʻo ʻana ma ke kahua lapaʻau no ka mea hiki ke kōkua i ka hōʻemi ʻana i ka nui o nā biopsies i waena o nā poʻe me nā kūlana maikaʻi o ka prostate a hiki nō hoʻi ke hoʻomaikaʻi i nā helu ʻike ma waena o ka poʻe i loaʻa i ka maʻi maʻi prostate. Me kā mākou CTC-hoʻonui a me ka ʻenehana ʻike ʻike, ʻaʻohe pilikia o nā hopena maikaʻi ʻole i waena o nā poʻe i loaʻa ʻole i ka maʻi prostate, "wahi a Dr Vineet Datta, Luna Hoʻokele o ka Hui. Ua loaʻa mua ka hōʻike hōʻoia CE a loaʻa i ʻEulopa ʻo 'Trublood-Prostate'. Ua hoʻopuka ka UK-NICE i ka makahiki i hala he MedTech Innovation Briefing e wehewehe ana i ka hōʻike he 'Game Changer'.
Hāʻawi ʻia ka Breakthrough Device Designation e ka FDA no nā polokalamu e hōʻike ana i kahi hiki ke hoʻomaʻamaʻa maikaʻi i nā maʻi weliweli e like me ke kanesa. Ke manaʻo nei ka Breakthrough Devices Program e hāʻawi i nā mea maʻi a me nā mea mālama ola i ka manawa kūpono i nā lāʻau lapaʻau i hāʻawi ʻia i kēlā koho ʻia e ka loiloi mua, ka hoʻomohala wikiwiki ʻana a me ka loiloi.