Diagnostics for Personalized Medicine
Creation of Genetic Testing Registry is underway
The National Institutes of Health (NIH) announced in March that it is creating a public database of genetic tests. Researchers, consumers, healthcare providers, and others will have access to the Genetic Testing Registry (GTR) to search for information submitted voluntarily by genetic test providers.   NIH director Francis Collins’s chief of staff, Kathy Hudson, said the agency will soon publish a notice in the Federal Register posing a series of questions about the project to...
Creation of Genetic Testing Registry Is Underway
The National Institutes of Health (NIH) announced in March that it is creating a public database of genetic tests. Researchers, consumers, healthcare providers, and others will have access to the Genetic Testing Registry (GTR) to search for information submitted voluntarily by genetic test providers. NIH director Francis Collins’s chief of staff, Kathy Hudson, said the agency will soon publish a notice in the Federal Register posing a series of questions about the project to...
Growth and challenges for personalized medicine
 The U.S. personalized medicine market is estimated at about $232 billion, currently, and is projected to grow 11% annually, according to a recent PriceWaterhouseCoopers (PWC) report titled “The New Science of Personalized Medicine: Translating the Promise into Practice.” The personalized medicine market is expected to nearly double in size by 2015 to more than $450 billion, and the personalized medical care segment of the market—which includes IVD products—is...
Personalized medicine: the time is right
                With more focus on the increasing cost of healthcare, the potential of companion diagnostics continues to grow in importance. Diagnostic tests that determine an individual's therapeutic responsiveness save scarce healthcare dollars and give patients better choices.   The year 1999 could be heralded as the official start of the personalized medicine movement, with several articles published on the topic in the popular...
Companion diagnostics working group formed
          The Association of Medical Diagnostics Manufacturers (AMDM) has created a working group specifically for issues related to the regulation of companion diagnostics. The group's chairman is Eric Lawson, project director for medical devices at Voisin Consulting Inc. (Cambridge, MA) and a member of AMDM. Lawson proposed the formation of the group in April of this year, in response to a request by industry colleagues who had been experiencing difficulty with...
Diagnostics get personal
          Personalized medicine is a hot topic in diagnostics today and has attracted major buzz in the popular media. But what, exactly, makes medicine personalized? What role do in vitro diagnostics play? Who are the scientists working right now to make personalized medicine a reality, and what are they up to?   To learn more about the details and potential of personalized medicine, IVD Technology editor Richard Park spoke with Leroy Hood, MD, PhD,...
Personalized medicine stakeholders reach out to HHS
            Javitt Terry A letter to HHS Secretary Kathleen Sebelius from both the Genetics and Public Policy Center of Johns Hopkins University (Washington, DC) and the Coalition for 21st Century Medicine (Arlington, VA) urges the secretary to make oversight of advanced diagnostic tests a priority during her tenure. The letter, dated April 30, 2009, and remarkable for its 108 signatories, implores Secretary Sebelius and HHS to “create...
Still an unknown future
    EDITOR'S PAGE     Overall, there are currently two applications for companion diagnostic testing. The first is to narrow the field of applications for drugs in development. Second, companion diagnostics are used to select those therapeutics with the greatest efficacy and the least probability of harmful side effects for particular patients.   According to Kalorama Information (New York City), the trends and factors that are expected to influence the...
EGAPP findings add fuel to debate over genetic tests
    TRENDS & PERSPECTIVES       Photo by iStockPhoto New reports by an independent working group supported by CDC add fuel to the debate over the benefits of and need for further scrutiny of the hundreds of genetic tests that have been developed in recent years for use in treating cancer patients.   The debate comes at a time when hope is on the rise for more personalized medicine, including determining which patients will benefit from which therapies...
Deloitte report examines ROI of personalized medicine
    TRENDS & PERSPECTIVES       At a conference held in January by the Personalized Medicine Coalition (Washington, DC), the Deloitte Center for Health Solutions (Washington, DC) released a study that examined personalized medicine's economic value proposition. The study looked at the importance of return on investment (ROI) for multiple stakeholders in advancing the adoption of personalized medicine. This report, “The ROI for Targeted Therapies: A Strategic...