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Medical Forum / Diseases and Disorders / Prostate Cancer / April 2006

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New prognostic test following RP

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RonL - 07 Apr 2006 05:09 GMT
There was a presentation tonight at our local support group by the vp/sales
at a company called Aureon.  If you've had an RP recently, you may want to
check this link:

http://www.aureon.com/

They are just beginning to market this "Prostate Px" diagnostic in the
northeast.  It's a prognostic test done on the same slides that are created
in post-RP pathology, but claiming much greater accuracy - in predicting
biological and clinical recurrence - than can be gleaned from the standard
pathology data.

Some points that came out in the talk, but not necessarily evident from the
website:

-  They claim significantly greater sensitivity in predicting both PSA rise
and clinical failure than is available from nomograms, even the Kattan
nomogram.  This is significant (I believe), since the Kattan nomogram comes
from Sloan-Kettering (MSK) data, and MSK data are partially behind the
development of this model.

-  On speaking with the guy privately, I learned that MSK urologists are
engaged in their own independent analysis of this company's data before
they'll endorse it fully.  I'm still a little confused, because the model
was *developed* with the help of at least two MSK surgeons - in a consulting
capacity, I would guess.  One is my own surgeon, so I will ask him
explicitly whether he endorses the technology.

-  Retail price of the Px test is just under $2000.  They are gathering info
about which insurance plans will cover how much.  They say that some chunks
of the test are broken down into traditional treatment codes, and so they
would be covered by any plan that covers those codes.  The implication was
that the average copay would be much less than the $2000, but it didn't
sound like they had much real world experience yet.

-  They readily admit that, even though they think they have the best
technology by far for post RP prognostication, most urologists don't
presently know about it, and even among those that do, there will be many
disinclined to use it because they won't see how the results could alter the
choice and timing of adjuvant therapy.

-  The most astounding thing I came away with was that this technology
purports to distinguish between "aggressive" vs. "indolent" PCa *within the
same Gleason score* much more accurately than is built into the
probabilities of any nomogram.

-  They are analyzing data from biopsy cohorts now, and hope to have a
product for *biopsy* slides in the fall.

-  When I asked whether their technology is based on published information,
they said there are a couple of papers that have been submitted to peer
reviewed journals.  (There's a list of papers on the website, but I couldn't
tell from the titles which might relate to the Px test.)  When I asked
whether they are distributing *preprints* to urologists, they said "we can't
do that."   Hmm.

-  The company is privately held, and a couple of big pharma companies
bought in on the second round of financing.  One was Pfizer; I forget the
other.

Anyway, thought I'd post the link FWIW.  As mentioned, my own surgeon seems
to be involved in some way, and I will ask him about it.  Will post back if
I get any insights into the value or efficacy of this test.  Meantime, I'd
appreciate any additional info from anyone here who may be familiar with
this company.

-RonL
Alan Meyer - 07 Apr 2006 17:23 GMT
I read once that the Roman Emperor Hadrian visited Egypt.  He was
taken to see a sorceress who offered, for princely fee, to kill
one of Hadrian's young slaves and add the boy's years to
Hadrian's, thus extending the Emperor's life.  To his great
credit, Hadrian declined the offer.  A hunting falcon was
selected for sacrifice instead.

The intersection of health and business has certainly become more
scientific since then, and at least the veneer of civilization
has gotten thicker.  But I think we might detect at least a faint
whiff of the ancient business practices in modern pharmaceutical
company sales techniques.

   Alan
I.P. Freely - 08 Apr 2006 23:14 GMT
> There was a presentation tonight at our local support group by the
> vp/sales at a company called Aureon. . . .

Alarms going off already. I demand science, not salesmen, when making
important decisions.

> Meantime, I'd appreciate any additional info from anyone here who
> may be familiar with this company.

IIRC, it was dismissed quickly when discussed here a few months ago.
hmmmmmmm . . . Oh,  yeah  ... Google aureon prostate and you'll get your
answer quickly. All you see is hundreds of sites blathering about the
Aureon news release, Aureon stock, financial opportunities, the banking
industry . . . not a freaking word about MEDICINE or TRIALS.

My alarm bell just went up in smoke.

I.P.
RonL - 10 Apr 2006 01:51 GMT
> IIRC, it was dismissed quickly when discussed here a few months ago.
> hmmmmmmm . . . Oh,  yeah  ... Google aureon prostate and you'll get your
> answer quickly. All you see is hundreds of sites blathering about the
> Aureon news release, Aureon stock, financial opportunities, the banking
> industry . . . not a freaking word about MEDICINE or TRIALS.

Yup, thanks I.P., there's a bunch of business type stuff on the net about
this company, and also one prior thread in this group, including
contributions from you.

In that thread, RonB said:  "Doesn't seem like they could do any more toward
predicting PCa coming back than is already being done. "  If the operative
word here is "predicting," then their current claims about this new Px
product go against this statement.  i.e.. They do claim to have a better
prognosticator than any heretofore, both for biological recurrence and
clinical failure.

However, I share you guys' skepticism, for the reasons you stated, and more.
For example, the cohorts they used for both training and testing their model
came from only two medical centers, MSK and Baylor.  For all we know,
without published data, that could mean as few as two surgeons are
represented.  (If you look here:

http://www.aureon.com/prostatepx/Pathologists.pdf

you'll see there were only 61 patients in the validation cohort for PSA
recurrence.  The largest of their four cohorts was 345 patients.  I'd have
thought the post RP (Kattan?) nomogram  [which can be accessed from here:
http://www.mskcc.org/mskcc/html/10088.cfm ]   for example, would be based on
much larger cohorts.  I have not actually checked that, btw.)

My guess is, they are testing waters with this post RP Px product.   (At one
point during the presentation, before he revealed the list price, the sales
guy polled the group on what they thought the Px product would cost.  He
also polled the group on their insurance plans.)  I'm guessing they expect
the post *biopsy* product, due in the fall, to be the big one.

Beyond being skeptical for reasons relating to lack of data, I am wondering
if there aren't ethical issues here as well.  Though it's not evident from
the website, one of the slides in the presentation indicated that the
founders of the company were, IIRC, all academic researchers at major
medical centers.  It sounds like they put their heads together and came up
with this "proprietary algorithm" upon which they could base a commercial
enterprise.  If they did this without publishing data, then one might ask
whether they were faithful to their academic contracts.  I'm not naive about
this stuff.  I worked nine years doing tech transfer for a major academic
medical center, so I know it goes on all the time.  Tech transfer from
academia to commercial ventures is a valuable activity.  I believe that, in
general, we all benefit from it.  (As an aside, there's a review in today's
NYTimes Books section on a new book by a Nobel-winning neurobiologist.  You
wouldn't know from the review, though, that he has cofounded, with two
academic colleagues, a commercial venture [called Memory Pharmaceuticals].)
But there are mechanisms - primarily the patent system - for protecting
commercial interests while making the data public, and it is reprehensible
for academicians to withhold their research from publication.

Anyway.  Bottom line: I went to my support group the other night feeling
pretty good about my post RP pathology:  G(3+3), T2b, negative margins, no
evidence of ECE, no evidence of vascular invasion.  I left feeling worried
again, because this company represented that one post RP G6 is not
necessarily like another.  One can be indolent, another aggressive.  And
they can tell the difference, but they're not telling exactly *how* they can
tell the difference.  Geez.  With support sessions like that, who needs
threats from terrorism, bird flu, and an autocratic presidency?  ;-)

-RonL
Alan Meyer - 10 Apr 2006 05:17 GMT
> ...
> Some points that came out in the talk, but not necessarily evident from the website:
> ...

Makes you wonder doesn't it?

I guess it shouldn't be surprising to discover that, when people
have to put their claims in writing in a public place from which
it's very easy to produce copies to show to regulatory authorities,
the claims become much more modest.

   Alan
 
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