Molecular Diagnostics
Novartis pursues molecular diagnostics in-house
    TRENDS & PERSPECTIVES     Nohaile Providing further evidence that the field of companion diagnostics is expanding, Novartis AG (Basel, Switzerland) has created its own Molecular Diagnostics unit. The group, formed at the end of last year and the beginning of 2009, is headed by Michael Nohaile, formerly the head of corporate strategy, with David Epstein as president and CEO of oncology and molecular diagnostics.   The new unit is expected to be fully...
Cost savings to drive genetic analysis
    FINAL THOUGHTS       James R. Prudent, PhD, is chief executive officer at Centrose (Madison, WI). He can be reached at prudent@ centrosepharma.com. When the Human Genome Project began in 1990, it was clear that genetics had the potential to dras-tically alter medical practice. Today, genetic tests can show predisposition to a variety of illnesses, including cancer, cystic fibrosis, liver diseases, disorders of hemostasis, and others. Genetic...
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...
Double-digit growth expected in molecular diagnostics
    TRENDS & PERSPECTIVES     According to a report released by Kalorama Information (New York City), “Molecular Diagnostics,” the worldwide market for molecular assays is estimated to have reached $3.7 billion in 2007. This market is expected to grow at an average annual growth rate of 11% and generate $6.2 billion in revenues by 2012. The report identified the following issues that could affect growth in this market and that molecular diagnostics...
Genetic analysis: Bringing better medicines to market
    FINAL THOUGHTS     James R. Prudent, PhD, is chief executive officer at Centrose (Madison, WI). He can be reached at prudent@ centrosepharma.com. Due to evolution, genetic changes have profoundly affected how drugs behave in different animal models. Mutations can also affect drug behavior. Such facts lead one to wonder how far personalized genetic-based medicine has come during the past decade. Personalizing medical care has typically meant...
Assessing progress (or lack thereof) in biomarkers
    FINAL THOUGHTS     Roger L. Lundblad, PhD, is an independent consultant located in Chapel Hill, NC. He can be reached at lundbladr@ bellsouth.net. A sense of frustration has emerged in the world of biomarkers. There is a perceived lack of progress in this area considering the hype that came with the start of the biomarker hunt. The term biomarker originally described organic compounds found in crude oil, which could identify the geographical...
Growing pains and learning curves
          Molecular diagnostics is becoming one of the dominant platforms in clinical laboratory medicine, representing one of the fastest growing segments in the IVD industry. It has emerged fully from research into clinical practice. According to Kalorama Information (New York City), the molecular diagnostics market totaled $3.21 billion in revenues in 2007. The market is expected to reach $5.42 billion by 2012 with an estimated annual growth rate of 11%....
Adapting life sciences technologies to IVDs
            Earlier disease detection and prediction are the preeminent goals for next-generation diagnostic technologies. For diagnostic systems based on detecting protein biomarkers, the likelihood of making earlier disease detection a reality depends on the following synergistic activities: discovering clinically relevant protein biomarkers that can differentiate between disease states, and developing and validating diagnostic systems with the...
Realizing the postgenomic promise in oncology testing
            Figure 1. Examining the raw data from the 92-gene RT-PCR CancerType ID test by AviaraDX (San Diego). A mantra that scientists have strived to uphold is “underpromise and overdeliver.” However, society is far from benefiting from a plethora of clinically relevant genomic tests that were supposed to transform individualized treatments. Instead, seven years after the landmark reporting of the Human Genome Project, there is a...
Diagnostics and therapeutics in partnership
            Walter Koch, PhD, is vice president and head of research at Roche Molecular Diagnostics (Pleasanton, CA). In 1998, Koch joined Roche Molecular's human genetics department to head up development of cytochrome P450 genotyping and p53 tumor suppressor gene resequencing assays. From May 2001 to January 2005, he served as director of Roche's pharmacogenetics department. He can be reached at...