FDA Pom zoo ua ntej-rau-ib-Qoos Test rau Cancer Gene Profiling

Nyob rau hauv no Aug. 15, 2017 ua daim duab, tus neeg mob Alison Cairnes, foreground, ntsia cov dluab nrog nws tus kws kho mob Shumei Kato ntawm University of California San Diego hauv San Diego. Tumor profiling uas tau tshwm sim los ntawm cov kab mob cancer hauv Cairns tau pab txhim kho txoj kev kho mob uas ua rau nws mob khees xaws mis nyuj. Txog hnub Thursday, Kaum Ib Hlis 30 lub US Food and Drug Administration tau pom zoo ib qho kev xeem los ntawm Foundation Medicine. (AP Photo / Gregory Bull, Cov Ntaub Ntawv)

US regulators tau pom zoo thawj zaug ntawm kev sib tw uas zoo rau kev hloov mus rau ntau pua ntawm cov keeb kwm mob qog nqaij nyug, muab ib daim duab ntau dua ntawm kev tsav tsheb tus neeg mob lub hlwb thiab pab txhawb kev kho kom haum rau cov kev tu siab.

US Food and Drug Administration tau pom zoo los ntawm Foundation Medicine qhov kev kuaj mob rau cov neeg mob uas muaj mob qog siab los yog ntau tshaj, thiab Cov Chaw rau Medicare thiab Medicaid Cov Lus Cog Tseg.

Cov kev txiav txim ob tog, tshaj tawm hnub Thursday, yuav ua rau cov neeg mob qog nqaij hlav ntau dua li cov neeg tau txais kev pab tam sim no, thiab txhim kho cov neeg tuav pov hwm ntau dua.

"Nws yog ib tus neeg tshwj xeeb, muaj tshuaj zoo," said Dr. Kate Goodrich, kws kho mob thawj coj rau lub koom haum saib xyuas Medicare.

Tam sim no, cov neeg mob yuav kuaj tau rau cov noob caj noob ceg yog tias muaj yeeb tshuaj rau cov hom kev hloov. Nws yog ib txoj kab-thiab-txoj kev mus uas tej zaum txhais tau hais tias ntau lub biopsies thiab khib sij hawm. Hauv cov qog nqaij hlav ntsws nkaus xwb, piv txwv li, txog ib nrab ntawm cov noob yuav kuaj xyuas nrog cov kev ntsuam xyuas ntawm tus kheej kom pom tau tias ib qho tshuaj twg yog qhov zoo sib tw.

Qhov tshiab FoundationOne CDx kuaj siv tau rau txhua yam khoom muaj xws li prostate, mis los yog nyuv kheesxaws, thiab kev ntsuam xyuas 324 noob thiab ntxiv rau lwm yam uas yuav pab tau kwv yees zoo nrog cov kev kho mob uas ua npe rau kev tiv thaiv kab mob.

"Siv ib lossis ob, koj muaj ntau yam" kev ntsuam xyuas ib zaug los ntawm ib qho kev kuaj nqaij xwb, hais tias FDA's Dr. Jeffrey Shuren. Cov kev ntsuam xyuas muab cov lus qhia zoo dua thiab ntxiv rau kev taw qhia txog kev kho mob thiab pab tau ntau tus neeg mob nrhiav thiab nkag mus rau cov kev tshawb fawb txog cov kev kho tshiab, nws hais.

"Qhov no yuav yog lub hiav txwv hloov" rau cov neeg mob, said Richard Schilsky, thawj kws kho mob ntawm American Society of Clinical Oncology, koom nrog cov kws kho mob uas kho tus kab mob.

"Ntawm qhov seem kuv xav tias qhov no yog qhov zoo," tab sis nws muaj qhov kev pheej hmoo tias qhov kev hloov pauv yuav ua rau cov kws kho mob thiab cov neeg mob sim ua cov kev kho mob uas tsis tau muaj pov thawj ua hauj lwm hauv qhov xwm txheej no thiab txhawb kev siv cov tshuaj qis tshaj said.

Ib qho ua tau zoo dua nyob rau hauv cov xwm txheej yog los coj cov neeg mus rau kev tshawb fawb kuaj cov tshuaj uas npaj hom noob, Schilsky said.

Foundation Medicine, raws li hauv Cambridge, Massachusetts, thiab lwm tus tau muag qog cov ntawv kuaj qis qis rau ob peb lub xyoos tom qab ntau tshaj xo txoj cai tswj kav kev tshuaj (lab). Tab sis cov muaj ntawv pov thawj tau txais kev pabcuam los ntawm cov kev xeem, uas raug nqi ib ncig ntawm $ 6,000.

Tam sim no, FDA qhov kev pom zoo muab kev ruaj ntseg zoo, Shuren tau hais, thiab tsoomfwv qhov kev npaj khomob rau Medicare thiab lwm cov kev pabcuam kev tuav pov hwm pejxeem txhais tau hais tias cov kev pabcuam ntiag tug yuav muaj feem ntau ntxiv.

Pej xeem cov lus hais txog qhov kev pab them nqi kho mob yuav siv sij hawm ntev txog 30 hnub. Kev txiav txim siab zaum kawg yuav tsum tuaj ntxov rau xyoo tom ntej no raws li kev tsim nqi rau kev them nyiaj rov qab.

Kev pab them nqi kho mob tau npaj rau cov neeg mob rov qab los yog cov mob qog nqaij hlav loj, hauv cov neeg uas tau txiav txim siab nrog lawv cov kws kho mob kom nrhiav kev kho mob ntxiv thiab cov uas tsis tau muaj qhov kev ntsuas qis dua yav tas los.

"Ntau yam ntawm cov neeg no tau khiav tawm ntawm cov kev kho mob," tab sis cov kev xeem yuav taw tes rau tej yam tshiab uas yuav pab tau, Goodrich said.

Cov kev xav tau yuav zoo tshaj plaws rau kev mob ntsws cancer, vim tias muaj ntau ntawm cov hlav no muaj nyob rau ntawm qib siab thiab ntau cov noob-hom phiaj tshuaj muaj nyob rau qhov ntawd.

Cov ntaub ntawv pov thawj tsis muaj zog txaus los siv kev siv cov kev kuaj cov noob no rau cov kab mob qaum ua ntej. Cov neeg mob tau txais kev saib xyuas, cov txheej txheem raws li cov txheej txheem.

Hauv Mid-Kaum Ib Hlis, FDA kuj tau pom zoo tias kev soj ntsuam cov qoob loo uas tau tsim los ntawm Memorial Sloan Kettering Cancer Center, tab sis nws siv ntau tus neeg mob ntawm qhov chaw kuaj mob thiab tsis pom muaj kev ntsuam xyuas kev lag luam.

Tsoom fwv teb chaws cov kev txiav txim siab yuav ua rau cov kab mob qog muaj ntau dua ntawm kev mob khees xaws, "zoo ib yam li peb pheej pom ib lub tshuab ua rau me me" los qhia txog tus kab mob ntawm tus neeg mob, "said Dr David Klimstra, thawj tswj ntawm qhov chaw cancer ntawm chaw kho mob.

Lwm tus thawj coj nyob rau hauv daim teb no, Caris Life Sciences, nws hais tias nws tseem npaj siab yuav ua raws FDA qhov kev pom zoo rau nws txoj kev siv cov qog siv tus kheej, ua tam sim no los ntawm kev sim (lab). Nws tseem ua hauj lwm rau lub cuab tam tshiab rau kev phais tawm ntawm noob caj noob ces los ntawm kev kuaj ntshav. Ntau lub tuam txhab tau muag cov kev kuaj dej qis no, tab sis tsis muaj FDA tso cai rau.

https://www.biosciencetechnology.com/news/2017/12/fda-approves-first-kind-test-cancer-gene-profiling