Apr 15, 2009 | Laboratory Pathology, Management & Operations
When Roche Holding AG (RO) of Basel, Switzerland, announced last month that it had an agreement to buy Genentech Inc. (DNA) of South San Francisco, California, it was big news. Roche had pursued the innovative drug maker since July with the primary goal of gaining access to the drugs in Genentech’s pipeline.
On March 11, Roche got the support of Genentech’s board to pay $95 per share to buy the 44% of the company it doesn’t already own. One intriguing reason why Genentech was so attractive to Roche is that the California company has a line of products and biomarkers that fit almost seamlessly with what Roche already offers, including Herceptin, HER2/neu assays, and biomarkers useful for both companies.
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Feb 11, 2009 | Laboratory News, Laboratory Pathology
Powerful, fast-moving trends are propelling pathology and radiology toward personalized medicine
February 11, 2009
It is no exaggeration to characterize the advances in molecular technologies as a huge “molecular asteroid” on a target path to smash Planet Pathology and Planet Radiology. That is the collective wisdom shared by experts speaking here in Philadelphia yesterday and today at the second annual Molecular Summit on In Vivo and In Vitro Integration.
This important conference, produced by The Dark Report, is the only global event which brings together innovators in the fields of molecular imaging, molecular diagnostics, and health informatics to share their progress on establishing integrated diagnostic and therapeutic services for clinicians and patients. Yesterday’s podium fireworks offered attendees impressive insights on the current level of molecular transformation underway in molecular imaging and molecular diagnostics-along with a impressive consensus on the future for these diagnostic areas.
For example, keynote speaker George Poste, DVM, Ph.D., Chief Scientist and Director of The Biodesign Institute of Arizona State University, laid out a compelling argument that personalized medicine is an unstoppable trend. Poste, a leading international expert on biomarkers, declared that multi-modality diagnostics will play an essential role in how healthcare evolves toward a pro-active healthcare system organized to serve the needs of personalized medicine.
Of particular interest to pathologists and laboratory professionals, Poste characterized the field of diagnostics as rapidly organizing around multiplex, automated, miniaturized assays, amid plenty of chaos as new science and technologies upset long-standing practices in laboratory medicine. He illustrated this chaos by noting that “there are approximately 157,000 biomarkers in the literature with some claim of validity. These biomarkers were developed mainly in academic settings and are supported mostly by anecdotal evidence.”
Throughout the day, experts at the Molecular Summit podium stressed several common themes about how molecular imaging and molecular diagnostics is transforming. These are valuable insights for the many pathologists and radiologists who work in community hospital settings and don’t often have the opportunity to participate in conferences such the Molecular Summit on In Vivo and In Vitro Integration:
* Personalized medicine is already happening. It is not an idea, but is now an active trend in the American healthcare system.
* There will be swift progress to move away from single-analyte assays (such as potassium and chloride) and single biomarker tests (such as HER2/Neu) in favor of multi-analyte assays. Microarrays with their tens of thousands of data points are just one example of how diagnostics is incorporating huge amounts of measurement points.
* Multi-modality disease assessment will become the norm. Molecular imaging, molecular diagnostics, and other relevant clinical data sets will be pulled together and assessed. Diagnosticians will then provide an integrated answer to the clinicians. This integrated answer will address diagnosis, therapeutic options, and patient monitoring.
* In anatomic pathology, technology will make it possible to extract quantitative data from specimens. The technology will reduce human variability in assessment of the specimen and will provide richer information for diagnosis, to guide therapeutic decisions, and patient monitoring.
Dark Daily will provide more insights from this Molecular Summit, which continues through the end of today. As noted above, there is strong consensus among the speakers that a transformation of diagnostic services is underway. Such a consensus among numerous experts in molecular imaging, molecular diagnostics, and health informatics is, by itself, confirmation that a major trend is unfolding.
Armed with this understanding, it explains why the metaphor of a huge molecular asteroid striking Planet Pathology and Planet Pathology is apt. Look for additional intelligence about the presentations and insights emerging from this year’s Molecular Summit!
Your Dark Daily Editor,
Robert L. Michel
Related Information:
2009 Molecular Summit on In Vivo and In Vitro Integration
Jul 24, 2008 | Laboratory News, Laboratory Pathology
Whether laboratory medicine is ready or not, Big Pharma is ready to crowd its way into the laboratory testing marketplace. The world’s largest pharmaceutical companies are recognizing that the success of their prescription drugs will increasingly depend on a clinically-useful companion diagnostic test. Since pharma companies like control over their products, Dark Daily predicts that deals between pharma companies and in vitro diagnostics (IVD) firms will soon be announced.
As this happens, laboratory medicine is likely to be influenced and transformed in ways that will be difficult for pathologists to control and influence. That’s because Big Pharma has tens of billions of dollars to invest in research, clinical trials, and development of products that support the introduction and clinical acceptance of new therapeutic drugs.
This development is directly linked to advances in genetics and molecular diagnostics. Researchers are identifying populations of patients with genetic attributes that either make them prime candidates to respond to a therapeutic drug or a lead pipe cinch to get no therapeutic benefit and even negative side affects. As this occurs for specific cancers and diseases, pharmaceutical firms are recognizing that, for their new drugs to accepted by clinicians and payers, it will need to have a companion diagnostic lab test that affirms that the patient will benefit. Of course, the most recognized example of a companion diagnostic is when the breast cancer patient is tested for the HER2neu mutation. Only if the patient is positive for HER2neu is she a candidate for the drug Herceptin.
Evidence of Big Pharma’s pending move into in vitro diagnostics comes from public statements at various scientific meetings and investor conferences. For example, last month, at the annual meeting of the Society of Clinical Oncology (SCO) in Chicago, discussion of promising new drugs in development invariably included mention of how bio-markers for companion diagnostics were part of the drug development and clinical trial process. Reporters Ron Winslow and Marilyn Chase of The Wall Street Journal covered this meeting, and wrote that research presented at SCO “highlights an important shift in cancer treatment and in attitudes of pharmaceutical and biotechnology companies toward ‘personalized medicine,’ in which treatment is tailored to an individual based on his or her genetic makeup. Companies are beginning to accept a smaller market for some medicines in return for a better chance that those who use them will have a good result.”
The key point to emphasize here is that Big Pharma has the potential to radically transform laboratory medicine as we know it today. Armed with the cash flow from $200 billion in prescription drug sales in the United States alone, Big Pharma has the clout, both financially and politically, to pursue its agenda with vigor.
Further, it should not be overlooked that imaging giants Siemens (NYSE: SI) and General Electric (NYSE:GE) are actively staking out their presence in the in vitro diagnostics sector. In the past 24 months, Siemens invested more than $14 billion to become the world’s second largest IVD manufacturer. On the pharma side, earlier this year, drug and IVD giant Roche Holdings AG (VTX:ROG.VX) invested $3 billion to acquire Ventana Medical Systems, Inc. and its $300 million in annual revenue.
Should the considerable activity of the imaging companies to enter the laboratory testing marketplace be matched by equal or greater activity from Big Pharma, then the traditional profession of laboratory medicine as we know it today is likely to undergo a far-reaching transformation. Lots of money generally implies lots of influence. If pathologists have been worried about how Siemens and GE, with their imaging revenues anchored in radiology, might change the collegial specialty of pathology, then think what can happen as Big Pharma starts pouring some of its billions into in vitro diagnostics with the goal of controlling bio-markers and pointing research into directions that serve their corporate objectives.
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