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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