F.D.A. Seeks to Regulate New Types of Diagnostic Tests
The Food and Drug Administration took a step yesterday toward regulating a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.
食品與藥物管理局昨天邁出一步於規範一新類別的複雜診斷測試, 複雜診斷測試預期將制訂具體病人治療並發揮越來越大的作用,.
Requiring approval before such tests can be marketed, the F.D.A. said, could better ensure that the tests are valid. But some experts said the requirement could also discourage the development of diagnostics by raising the costs of introducing them.
需要通過檢驗才能上市,FDA表示這樣才更能確保測試是有效的。 但也有專家表示如此一來這樣的要求需要更多的開發成本將降低發展診斷方法的興趣
“We don’t want to see innovation and access inhibited,” said, director of the Genetics and Public Policy Center at Johns Hopkins University. “On the other hand it’s really important to make sure that patients and providers have accurate and reliable tests. It’s a fine balance.”
我們也不希望抑制創新與接受的途徑」約翰霍普金斯大學遺傳和公共政策中心Kathy Hudson主任表示,"而一方面很重要的是可以確保病人及提供者有準確、可靠的測試,這是很好的平衡.
The new policy, published yesterday as draft guidelines open for public comment, would also be a step toward expanding the F.D.A.’s oversight to clinical laboratories.
昨天公佈的準則草案公開尋求公眾意見。這項新政策也進一步增加了F.D.A. 對臨床實驗室的監督。
The F.D.A. already requires approval of diagnostic test kits that are sold widely to labs, hospitals and doctors, considering them to be medical devices. But tests developed and performed by a single laboratory, known in the trade as home-brew tests, have been generally considered lab services and outside F.D.A. purview.
<F.D.A. 要求已經有廣泛銷售實驗室、醫院和醫生等自我認定為診斷測試的套件組通過核可。但是由單一試驗室開發及呈現,以自行測試做為銷售方式,外界普遍認為是實驗室服務而不在F.D.A. 權限.
Now the F.D.A. is saying it will regulate at least one category of such tests: those that measure multiple genes, proteins or other pieces of clinical information taken from a patient and then use an algorithm or software program to analyze the data. The F.D.A. is calling these tests “multivariate index assays.”
現在F.D.A. 說這樣將至少規範這一類考驗--這些會測試多重基因、蛋白質和其他一些取自病人臨床資料然後用軟體程序和算法數據分析。
Perhaps the most well known of the tests is Oncotype DX, offered by Genomic Health of Redwood City, Calif. Costing about 3,500, it analyzes the activities of 21 genes in a sample of breast tumor and then computes a score that is said to be predictive of whether a patient’s cancer will recur and whether she would benefit from chemotherapy.
這一類的試驗中最知名的是由加洲紅木市的基因健康提供的Oncotype DX。花費約3,500,分析21乳房腫瘤基因樣本的活性,然後計算分數可以預測病人的癌症的再現性及可否會用化;療得到治療.
While there are only a few such complex tests on the market now, their number is expected to grow. Scientists are finding in many cases that a combination of genes or proteins is a better indicator of disease or disease risk than a single gene or protein.
雖然市面上面試僅有少數的複雜測試,未來數目預計增長,
科學家發現在許多情況下, 相較於單一個疾病基因或蛋白質,結合基因、蛋白質是診斷疾病的較佳指標.
F.D.A. officials said such tests needed regulation because the algorithms used are usually proprietary, making it hard for doctors to interpret the test results.
F.D.A. 官員說,由於這些測試需要標準規定,因為這必須使用專屬算法, 讓醫生不容易解釋檢驗結果.
“It’s important for the agency to look at the data on which these tests are developed,” the director of the F.D.A. Center for Devices and Radiological Health, said in an interview.
"主管單位需要觀看正在發展的診斷方式的測試數據,很重要的F.D.A. 健康設備及輻射中心主任, Dr. Daniel Schultz在接受採訪時表示。
The F.D.A. said it would decide case by case what to do about the tests already on the market. Some might have to come off the market until the developer can provide enough data for approval. However, officials said they would work toward the “least burdensome” approach.
F.D.A. 表示已上市的試驗將依個案不同來決定應如何處理
其中一些可能會離開市場,直到開發者可以提供足夠的資料一直到核可通過. 但官員說,他們將用"最簡單的’方法來處理
Some experts have been calling for either the F.D.A. or the Center for Medicare and Medicaid Services, which regulates clinical labs, to bolster regulation of genetic tests.
部分專家呼籲無論是F.D.A. 醫院和醫療中心、服務規範等規範臨床實驗室之單位應加強基因診斷的管理.
“There’s been a gaping hole in the oversight of genetic tests,” Dr. Hudson of Johns Hopkins said. “We have seen a tenfold increase in the number of genetic tests available over the last decade and an even greater increase in the complexity of those tests.”
約翰霍普金斯的博士Dr. Hudson表示"過去在基因診斷測試的監督是個大漏洞,. 我們看到過去十年提供的基因測試增加十倍增加, ,並更加許多試驗的複雜性.
At a Congressional hearing in July, Senator Gordon Smith, Republican of chastised both agencies for not doing more to clamp down on what he called questionable genetic tests that are being sold directly to consumers.
Oregon,州共和黨史密斯先生在國會公聽會7月參議員, 譴責兩個主管機關都未做到限制這些他所謂的有待質疑之基因測試,這些基因測試直接出售給消費者.
But some test developers and testing laboratories have said that requiring clinical trials and F.D.A. approval would discourage development of tests, which do not usually command the same profits as drugs. They have also argued that the requirement would discourage gradual improvements of tests because each change in a test might require a new regulatory submission.
有的試驗開發者和試驗實驗室說, 需要臨床實驗及F.D.A. 通過會阻止試驗發展, 因為試驗並沒有達到如同藥品的效果. 他們還說, 要求會造成更多的阻礙,每個試驗測試的改變可能都需要向管理單位提出了新的申請。
“I’m not sure we could exist at all if we were required upfront to have F.D.A. approval,” Randy Scott, the chief executive of Genomic Health, said in an interview earlier this year. Mr. Scott was on a plane yesterday and could not be reached for comment.
. "我們不知道如果我們有必要事先得到F.D.A. 通過,我們是否可以生存, "基因健康CEO Randy Scott在今年初訪問中提到, Scott先生是一位昨天因在飛機上沒法做評論.
Even before yesterday, the F.D.A. had been sending letters to certain testing laboratories, including Genomic Health, questioning whether their tests should be regulated. The draft policy issued yesterday has raised speculation that the F.D.A. will eventually move to regulate additional laboratory tests beyond the complex ones.
昨天之前,F.D.A. 已發信給包括基因健康在內的一些基因試驗實驗室,質疑他們的診斷是否需要被規範, 昨天發佈的政策草案提出猜測是否F.D.A. 最後提出進一步對於複雜的基因測試要求更多的實驗室試驗.