I have written a number of previous notes about IVDMIAs. More recently, I have discussed the Coalition for 21st Century Medicine, which is a lobbying organization that has been organized to oppose the regulation of IVDMIAs. I recently came across a business article that makes reference to the various companies comprising and underwriting the Coalition (See: Valley biotech interests give FDA an earful over regulations) Below is an excerpt from it:
...Target Discovery CEO Jeff Peterson says his company that utilizes protein isoforms to diagnose ovarian and prostate cancers may not be exempt from new FDA regulations imposing major new controls on genetic testing laboratories. When the FDA ...issued a draft guidance imposing major new controls on genetic testing laboratories, small biotech labs across the country were caught off guard. No one in personalized medicine -- a field dominated by small companies in Northern California and Boston -- had imagined that the agency was prepared to extend its reach into their still-arcane world. Within a couple months, biotech companies joined forces with venture capitalists, academic researchers and patient advocacy groups to create the 21st Century Medicine Coalition....Now, the deadline for discussion is over and the FDA is finalizing new regulations that, while vague, promise to provide an independent assessment of the data and labeling claims..."But when I slept on it," [said an industry representative], "I realized that the [FDA's] driving rationale is that they want to be involved in personalized medicine decisions.
When I first read this article, I was somewhat surprised that the companies that have created the Coalition for 21st Century Medicine were referred to as biotech labs and their market sector as personalized medicine. There was nary a mention in the piece about the in-vitro diagnostic industry which is where I personally would place them. My understanding of healthcare delivery presupposes a distinct diagnostic phase of care for patients followed by a treatment or therapeutic phase. With personalized medicine, however, it may sometimes be hard to distinguish where diagnosis ends and therapy begins. In other words, the two phases may be merging under personalized medicine. For example, biomarkers can potentially be used not only to diagnose a tumor but also to monitor how a tumor is responding to chemotherapy. Similarly, medical imaging, and molecular imaging in the future, can be used not only to identify the location of a tumor but also to measure whether a treated tumor is shrinking. In-situ biomarkers can be used to deliver toxic agents directly to malignant cells.
I have previously discussed the telescoping of diagnosis into treatment. One example is the cardiologist morphing into a cardiovascular medicine specialist with control over hospital-based "cath labs" for both diagnostic angiography and therapeutic stent placement. Another example is the use of portable ultrasound devices by emergency medicine specialists and even medical students in clinical settings. These examples notwithstanding, I continue to believe that there will the very high value of diagnostic specialists in medicine will continue. However, I also see the value of a merger of pathology, lab medicine, and radiology into a Department of Diagnostic Medicine.
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