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XMFHelical (< 20)

Issues with Diagnostics



August 03, 2008 – Comments (0)

Well the blog has suffered as the Community Analyst Team responsibilities and self-imposed homework came to the forefront.  Oh well.  I will stay on program with updating the monthly moves in the port a bit later.  The CAPs port has been good to me, and I've broken into the top 500.  Didn't really expect to do that with a mostly bullish sector specific port.


But on to diagnostics, a biotechnology segment I've been overall bullish on.  I also pointed out that diagnostics have some very real risks, mostly centered around utility (why get the test) and reimbursement (who will pay for it).  NOT so much whether the test works.  I bring this up again due to a very good article from GenEngNews on diagnostics.


Excerpt: Many of the genetic tests offered today have little or no evidence of clinically proven value. Moreover, the regulatory infrastructure to apply due diligence on the utility and validity of these tests is largely nonfunctional or nonexistent.

The article though is more regulation than market biased toward diagnostic tests, calling for more FDA oversight.  This is Ok, but honestly it is the health care providers that will make or break a particular test.  Demonstrate utility and clinical relevance i.e. a result that dictates a treatment path forward, and you should be in good shape.  More and more, particularly in oncology, diagnostic biomarker and genetic information is being collected in phase II trials (which increases their cost) to better determine later trial success.  This is a good sign for both the test makers and pharma industry.



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