dr. desalvo: i can get back to you on that. >> i am almost out of time. dr. desalvo: thank you. >> thank you senator cassidy senator bennett. senator bennett: thank you to the panel. dr. shurman there is a movement of molecular diagnostics on the way. thank you to the human genome project, there are a number of colorado companies which are developing remarkable new diagnostic scenarios, like ebola, cardiovascular disease, lung cancer and the fda recently released a chaff on how to regulate lab tests. as i wrote in a letter a couple of weeks ago, as always we need to balance innovation and safety to make sure that we create a workable process. there is some concern that the draft work could require the fda to it prove -- to approve thousands of labs and test. can you speak to this given the spoke -- scope of the problem are you open to congressional action, without be useful and how to we get a handle on this and create predictability for the people doing this work? dr. shuren: lab tests plate an important role, we do not want to shut down lab tests but make su

dr. desalvo. dr. shuren. >> chairman alexander, ranking members murray and distinguished members of this committee. thank you for the opportunity to testify regarding fda's role in the precision medicine initiative. the success of precision medicine depends on having accurate, reliable and clinically meaningful tests. it's the results of the tests that determine which patients get which drugs or treatments and whether or not they get them. inprecise medicine results from bad tests, misdiagnosis, you get the wrong treatment or you get no treatment at all when you should. and as a result patients get harmed and health care costs go up. fda's role in the initiative is in a technology called next generation sequences. ngs can sequence long segments of a person's dna or the entire genome. we're moving away from the model of one test one disease. but a test that can identify one of many different diseases or the risk of developing that disease. but today there are significant barriers in place for advancing

dr. desalvo. dr. shuren. >> chairman alexander, ranking members murray and distinguished members of this committee. thank you for the opportunity to testify regarding fda's role in the precision medicine initiative. the success of precision medicine depends on having accurate, reliable and clinically meaningful tests. it's the results of the tests that determine which patients get which drugs or treatments and whether or not they get them. inprecise medicine results from bad tests misdiagnosis you get the wrong treatment or you get no treatment at all when you should. and as a result patients get harmed and health care costs go up. fda's role in the initiative is in a technology called next generation sequences. ngs can sequence long segments of a person's dna or the entire genome. we're moving away from the model of one test one disease. but a test that can identify one of many different diseases or the risk of developing that disease. but today there are significant barriers in place for advancing t