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XMFHelical (< 20)

Cepheid making the Move



September 27, 2007 – Comments (0)


Cepheid is my best performing CAPS selection and the company that has me firmly in the lead in a picking contest on the biotechnology board.

I like this company because they are at the forefront of capitalizing on the genomic data revolution.  I also like the controlled approach they have taken.  Cepheid didn't jump in whole hog with every assay under the sun and sky high promises - they took a steady approach to making clinical genetic analysis via PCR practical. 

They started with the instrumentation that was real-world battle tested in post offices around the country scanning for Anthrax.  I feared when they rolled this out that it could be a disaster - specifically that after the hoopla died down there was the likelihood that there would be NO additional instances of Anthrax in the post office.  This has been the case. What I worried about was that the occasional false positives that could shut certain POs down for a day or two would just feed a media frenzy and reflect poorly on Cepheid.  This has not played out (and I'm very very impressed).

Being battle tested, they then sought to put their PCR instrumentation into clinical practice, and importantly they went for certification in lower (moderate) complexity laboratories - a step that allows the analysis to be performed closer to the patient, and more rapidly.  Samples can be evaluated in many cases on site rather than shipped to a outside specialty vendor and waiting a few days.  Cepheid got moderate complexity approval not with a slew of assays - but a single one - analysis of Group B strep.  It is easy to identify strep infection, but very important to identify the type of strep in certain instances.  So they started with infectious disease - not full blown personalized medicine.  Smart IMO.

The follow on was an MSRA test.  Again here with infectious disease - where you don't need Cepheid to identify the infection, but do need them once it has been identified to see if it's particularly lethal and how it should be treated.  It is important that this second step be done rapidly - hence having the analysis close to the patient (in moderate complexity labs) is key.

Now it should start to snowball.  The hard steps were to get the instrument approval and the first few tests validated and established in hospital laboratories.  This is still underway.  But now, adding additional tests onto an established platform is much simpler.  So recently we have this press release.

 Cepheid said today that it plans to use a family of human papillomavirus patents it has exclusively licensed from the Swedish company Quantovir to develop a PCR-based diagnostic test for HPV that will predict a woman’s risk for developing cervical cancer.

Likely requires registration so try this as well.

This is a wonderful transitional test.  It is still infectious disease that will be assayed - the HPV virus.  Once testing positive for HPV, it is important to know whether it is a particularly aggressive version or not and this requires genetic analysis.  It also fits with PCR - you don't need an array to determine the strain, it's overkill since there aren't that many versions.  The need for this result to be returned rapidly isn't as great as for type B strep or MRSA, but if the site is already established with Cepheid's instrumentation, why wait (especially if it isn't cheaper to send samples out). 

And importantly, this signals to me that Cepheid is transitioning from infectious disease to personalized medicine.  HPV is a key infectious agent that will get oncology departments involved with rapid PCR genetic analysis.  It will not be long before more oncology related tests will be requested (and made available), including those based on the patients genomic info instead of infectious agents.  Cepheid has their foot in the door ahead of most other diagnostic companies.

My only regret is I never bought the company in real life.  Oh well.

That was a bit rambling, but no time to proof-read.


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