Diagnostics for Personalized Medicine
Companion Diagnostics: A Blossoming Field
Companion diagnostics are emerging as a key part of personalized medicine. Particularly in oncology, patients are being better served by drugs for which patients are selected via in-vitro diagnostic tests. The field is promising but nascent: so far, the potential of companion diagnostics is greater than the number of drug-and-diagnostic products that is actually commercially available. To find out why this is the case, and to learn more about the future of companion diagnostics, IVD...
Appeals court overturns ruling on gene patents
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovarian cancer. The appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. “The ruling is a blow to the idea that patent law...
FDA releases guidance on companion diagnostics
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion diagnostic that is intended to be used with a corresponding drug. Industry analysts were positive in their overall assessments of the guidance. “The draft guidance is helpful in several...
GE To Invest $1 Billion in Cancer R&D
GE announced this fall its plan to invest $1 billion during the next five years on R&D programs aimed at detecting, diagnosing, and treating cancer faster and more effectively. GE’s primary focus is on detection and treatment of breast cancer, with an eye toward cancerous tumors of all kinds. Ron Andrews, CEO of Clarient, a GE Healthcare company, believes $1 billion is the right amount at the right time. “We believe this number is something GE can digest, and it is significant...
GE Acquires Clarient: In vivo meets in vitro
GE Healthcare purchased Clarient Inc. (Aliso Viejo, CA) late last year. The acquisition was announced in October; U.S. regulators approved the transaction the following month.  GE, a well-known player in diagnostic imaging, is looking to lengthen its reach into molecular diagnostics (MDx), particularly in the oncology realm. With its acquisition of Clarient, it gains the potential for playing a large, comprehensive role in diagnosing and treating cancer. “Clarient is a clear leader...
FDA on Personalized Medicine
FDA anticipates more and more companion-diagnostics submissions in the coming months and years. Currently no formal process for these submissions exists, but that may change in the near future. To learn more about the current and future regulation of companion diagnostics at OIVD, IVD Technology editor Richard Park spoke with Liz Mansfield, OIVD’s director of personalized medicine. In this interview, Mansfield talks about the upcoming draft guidance for companion-diagnostics regulation,...
15th Anniversary Roundtable: IVD Past, Present, and Future: Three Experts Weigh In
In vitro diagnostics is, by many accounts, an underrated, undervalued industry. While pharmaceutical and therapeutic medical-device innovations tend to garner most of the mainstream media’s attention, the fact remains that 60 to 70% of medical decisions are influenced by some type of diagnostic testing, yet diagnostics accounts for only a tiny fraction of overall healthcare spending.  Some of the major developments within this very important industry during the past 15 years include...
15th Anniversary Essay: Looking Back: The Challenge of Companion Diagnostics
 Very often, looking back provides a thoughtful base for understanding how technology will enable future progress. The focus of laboratory testing as a tool for diagnosis, selection of appropriate therapy, and monitoring the progress of treatment has developed over decades. Testing continues to improve in terms of analytical validity, clinical utility, and reduced cost. There is nothing new about the concept of using diagnostic testing to guide therapy. Diabetics have measured their urine...
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...