FDA对Hiv基因型分析的指南可有利于 Visible Ge
&nbps;&nbps;&nbps;&nbps;NEW YORK (Reuters Health) - The US Food and Drug Administration (FDA) issued draft guidance last week regarding In Vitro HIV Drug Resistance Genotype Assays that outlined two methods for obtaining market clearance for HIV resistance assays.
&nbps;&nbps;&nbps;&nbps;The guidance appears to be an effort by the agency to regulate many "home brew" assays that have emerged in the diagnostics market in response to new mutations of HIV, and it could ultimately benefit Visible Genetics Inc., which is awaiting FDA approval for its genotype assay.
, http://www.100md.com
&nbps;&nbps;&nbps;&nbps;In the draft guidance, the FDA suggests that companies may obtain clearance of HIV mutation assays as a Class II device by rigorously demonstrating analytical sensitivity to listed mutations. A second, less rigorous method of obtaining approval would be to submit clinical data that demonstrates some form of medical benefit.
&nbps;&nbps;&nbps;&nbps;In a research report to investors, Robertson Stephens analyst Edward Tenthoff advised clients that most companies probably would pursue approval by demonstrating analytical sensitivity to listed mutations. Though the new guidance appears to be more rigorous than previous standards in the market, Tenthoff noted that conducting "clinical trials is an expensive and timely endeavor, and thus...requiring only performance data is the path" that most market participants will follow.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Toronto-based Visible Genetics, which has an application pending for its TruGene HIV-1 assay, should be able to meet the new standards of analytical sensitivity, according to Robertson Stephens. If the FDA approves TruGene next month, as anticipated, Robertson Stephens expects the TruGene HIV-1 assay to become the standard for the new guidance. Therefore, future assays entering the market would have to meet the same analytical sensitivity requirements of TruGene.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Celera Diagnostics, a joint venture of Applied Biosystems and Celera Genomics, filed a 510(k) application with the FDA seeking market clearance of its ViroSeq HIV-1 Genotyping System as an in vitro diagnostic kit in early August. ViroSeq is being tested in a large study in Brazil to identify drug resistance patterns early in the detection of HIV. The ViroSeq study is partially funded by the World Bank.
&nbps;&nbps;&nbps;&nbps;The FDA defined HIV resistance tests to include two main components: the genotypic assay itself and the interpretation algorithm. To obtain approval, the draft guidance recommended that companies submit scientific performance data regarding the assay, specify the protocols for in-house and external testing, and submit test results with analyses and conclusions.
&nbps;&nbps;&nbps;&nbps;The agency proposed that in vitro studies validate the phenotypes predicted by the genotypic test in order to demonstrate the performance of the interpretation algorithm. Companies also must include information about instruments used to generate the submission data., 百拇医药
&nbps;&nbps;&nbps;&nbps;The guidance appears to be an effort by the agency to regulate many "home brew" assays that have emerged in the diagnostics market in response to new mutations of HIV, and it could ultimately benefit Visible Genetics Inc., which is awaiting FDA approval for its genotype assay.
, http://www.100md.com
&nbps;&nbps;&nbps;&nbps;In the draft guidance, the FDA suggests that companies may obtain clearance of HIV mutation assays as a Class II device by rigorously demonstrating analytical sensitivity to listed mutations. A second, less rigorous method of obtaining approval would be to submit clinical data that demonstrates some form of medical benefit.
&nbps;&nbps;&nbps;&nbps;In a research report to investors, Robertson Stephens analyst Edward Tenthoff advised clients that most companies probably would pursue approval by demonstrating analytical sensitivity to listed mutations. Though the new guidance appears to be more rigorous than previous standards in the market, Tenthoff noted that conducting "clinical trials is an expensive and timely endeavor, and thus...requiring only performance data is the path" that most market participants will follow.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Toronto-based Visible Genetics, which has an application pending for its TruGene HIV-1 assay, should be able to meet the new standards of analytical sensitivity, according to Robertson Stephens. If the FDA approves TruGene next month, as anticipated, Robertson Stephens expects the TruGene HIV-1 assay to become the standard for the new guidance. Therefore, future assays entering the market would have to meet the same analytical sensitivity requirements of TruGene.
, 百拇医药
&nbps;&nbps;&nbps;&nbps;Celera Diagnostics, a joint venture of Applied Biosystems and Celera Genomics, filed a 510(k) application with the FDA seeking market clearance of its ViroSeq HIV-1 Genotyping System as an in vitro diagnostic kit in early August. ViroSeq is being tested in a large study in Brazil to identify drug resistance patterns early in the detection of HIV. The ViroSeq study is partially funded by the World Bank.
&nbps;&nbps;&nbps;&nbps;The FDA defined HIV resistance tests to include two main components: the genotypic assay itself and the interpretation algorithm. To obtain approval, the draft guidance recommended that companies submit scientific performance data regarding the assay, specify the protocols for in-house and external testing, and submit test results with analyses and conclusions.
&nbps;&nbps;&nbps;&nbps;The agency proposed that in vitro studies validate the phenotypes predicted by the genotypic test in order to demonstrate the performance of the interpretation algorithm. Companies also must include information about instruments used to generate the submission data., 百拇医药