Dr. Steven I. Gutman

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  triad.bizjournals.com/triad/stories/2008/10/06/daily37. - [Cached Version]
  Published on: 10/8/2008    Last Visited: 10/9/2008  

  In a letter dated Sept. 29, Steven I. Gutman, director in the office of In Vitro Diagnostic Device Evaluation and Safety with the FDA, wrote to LabCorp president and CEO David P. King that the company's OvaSure has not received proper approval.

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  www.amdm.org/AMDM/Presentations.html - [Cached Version]
  Published on: 11/1/2004    Last Visited: 3/13/2007  

  Steve Gutman, M.D., FDA
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  Dr. Steve Gutman

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  www.hemonctoday.com/article.aspx?rID=26863 - [Cached Version]
  Published on: 3/10/2008    Last Visited: 6/11/2008  

  Steven Gutman, MD, MBA
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  Steven Gutman
  
  Molecular diagnostics and genetic/genomic testing "is a very hard science to tame," according to Steven Gutman, MD, MBA, director, Office of In Vitro Diagnostics at the FDA."Clinicians underestimate the difficulty with the assay; it can be analytically challenging.They underestimate how biologically complex humans â€" and cancers â€" are."
  
  According to Gutman, eventually predictive diagnostic testing may determine drug selection, whereby the safety and effectiveness of a particular therapy may be in danger of becoming hostage to the test.
  
  "Proper sampling is really important.For some of the more complex tests, like Mammaprint or some of the multivariate assays or multiple single assays, there are very complex issues of properly interpreting the data," Gutman said.
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  "In all fields, researchers are looking for new biomarkers and trying to link them at the very least to treatment and at the most to either diagnosis or early detection or prevention," Gutman said.

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  www.wsbt.com/news/health/28425464.html - [Cached Version]
  Published on: 9/15/2008    Last Visited: 9/15/2008  

  "It's not a question of if, it's a question of when the right test will come along with the right credentialing to help improve health care in this important area," says Dr. Steven Gutman, FDA's diagnostic testing chief.

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  www.forwoman.net/news/english/602856.htm - [Cached Version]
  Published on: 3/16/2007    Last Visited: 3/31/2007  

  Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, agreed the test should not be used as a stand-alone for diagnosing viral meningitis."The test is designed to be used along with other tests," he said.
  
  Having to wait for other tests does mean that the quick turnaround of the Xpert EV test becomes a less important factor, he said.
  
  More information
  
  For more information on meningitis, visit the U.S. Centers for Disease Control and Prevention.
  
  SOURCES: Steven Gutman, M.D., director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Lise E. Nigrovic, M.D., attending physician, pediatric emergency medicine, Children's Hospital Boston, and instructor in pediatrics, Harvard Medical School, Boston; Nathan Litman, M.D., director, pediatrics and pediatric infectious diseases, Children's Hospital at Montefiore Medical Center, New York City; March 16, 2007, FDA press statement

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  www.iamishisname.com/did_you_know.html - [Cached Version]
  Published on: 10/12/2008    Last Visited: 5/16/2007  

  I hope we spent a lot of time creating a rule we never have to invoke," said Dr. Steve Gutman, director of the FDA's in-vitro diagnostics office.

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  www.columbustelegram.com/articles/2008/09/15/ap/washing - [Cached Version]
  Published on: 9/1/2008    Last Visited: 9/15/2008  

  "It's not a question of if, it's a question of when the right test will come along with the right credentialing to help improve health care in this important area," says Dr. Steven Gutman, FDA's diagnostic testing chief.

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  www.prevention.com/article/0,5778,s1-1-93-0-7842-1,00.h - [Cached Version]
  Published on: 3/1/2007    Last Visited: 3/30/2007  

  But the test, called MammaPrint, has shortcomings, says Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices.It requires careful use and diagnosis by doctors who know their patients.
  
  Women determined to be at high risk of cancer recurrence at 5 years have a 23 percent chance that the disease will reappear.Conversely, for women at low-risk, the test is 95 percent accurate that cancer will not return, Gutman said.And at 10 years, women gauged at high risk for recurrence have a 29 percent chance their cancer will recur, while low-risk patients have a 90 percent chance the cancer will not return, he said.
  
  "This information has to be used very carefully by physicians in the context of what they know about the history of the patient, the diagnostic options and the treatment options," Gutman says.

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  www.cancerfacts.com/Home_News.asp?NewsId=2128&CB=14&Can - [Cached Version]
  Published on: 2/8/2007    Last Visited: 3/1/2007  

  "There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex tests," says Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation.

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  www.devicelink.com/ivdt/archive/08/09/008.html - [Cached Version]
  Published on: 9/16/2008    Last Visited: 9/16/2008  

  Steven I. Gutman, MD, director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
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  Steve Gutman
  
  As director of OIVD, Steven I. Gutman is as enthusiastic about the future of the IVD industry as Neff and Nordhoff.
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  Like many in the field, Gutman sees molecular diagnostics growing because it will enable clinicians to deliver personalized healthcare, which promises not only earlier diagnosis and more-effective treatments but also can be very cost-effective, especially in the long run.
  
  Gutman believes that FDA plays a very important role in all that is happening in the field as it moves forward with new diagnostic tests and new applications."It is my view," he says, "that the FDA regulatory process is an important step in the translation of new products from the research bench to the clinical bedside.We contribute substantially to assuring the quality of analytical and clinical performance of the new tests with our independent review of the data, and we provide transparency in the credentialing process in terms of new development of new technology."
  
  From his perspective, Gutman says, he sees OIVD as neither the monster nor an obstacle in the room."FDA clearance or approval is simply one part of the journey to the moon," he says, "and I truly believe in the importance of grounding new tests in evidence-based information, utility information, medical need information, and economic information."Obtaining all that information is necessary, he says, "to convince third-party payers to reimburse for the new tests and to convince often- overwhelmed clinicians to use new technologies well and, frankly, to use old tests properly."
  
  There is no question, Gutman says, that personalized medicine and genomics are the future of IVDs, and FDA is trying to be flexible and help companies that are hoping to bring new products and tests in this arena to market while protecting the public safety.
  
  "Our group has been particularly aggressive in using the de novo regulatory process to allow products to come in," he says."We have also been very effective in using the protocol review process to allow for early interactions with companies to discuss new products, and we have used, when appropriate, expedited reviews.We also have used real-time reviews to bring products to market in a timely manner.So I think we have shown remarkable flexibility and facility in bringing in cutting-edge new products."
  
  Gutman says FDA's role in approving in vitro diagnostic multivariate index assays (IVDMIA), tests that use mathematical formulas to interpret gene and protein data to guide medical decision making, is still under review.FDA has taken the position that such tests, ordinarily overseen by CLIA regulations, must instead be cleared or approved by the agency due to their complexity.While a draft rule is still pending, FDA has enforcement discretion, Gutman says."Enforcement discretion suggests we believe that laboratory-developed tests are medical tests, and that the labs creating them are manufacturers and meet the definition.However, as a matter of history and deployment of resources, we're currently not choosing to actually apply FDA regulatory processes to those particular types of tests."Gutman refused to predict how this issue will be resolved."I just don't make predictions," he says.
  
  What new innovations does Gutman expect to see from IVD companies?"I am not prescient," he says, "but everywhere I look, I see new detection systems, new and more- complicated software systems with interpretative algorithms.I see imaging systems and biosensors.I see the ability to make technology more compact, expansion in applications of multiplex technology, expression assays, new applications of genomics, proteomics, and metabalomics, and new applications where people will see immune response to pathological changes."
  
  While all of it is very exciting, Gutman says, he can't say which areas and devices will gain the most attention and have the biggest impact as technology moves forward.All he knows, Gutman says, is that it is a "very challenging time" for FDA to "keep track of this rapidly evolving field."As the technology becomes much more complicated, he says, "the agency has been much more involved not only in premarket review but also in development of tools for risk assessment and policy development, and it will continue to do so to protect the public health."
  
  Gutman recognizes that as a regulatory agency, "FDA is not everyone's favorite."But he believes that IVD companies and FDA recognize that they have mutual interests in improved yet safe patient care, and can and will continue to work together to promote them.

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