AutoCyte (SurePath, AutoCyte PREPTM System)
better than ThinPrep 2000® System
This is controversial! Since this is our pathology
group website, the following is obviously the opinion of our decision
makers and not the same as an official publication in an official
medical or scientific journal. It is our "why so?" to
our clients who may be aware that there is controversy in things
medical. But, I have decided to replace this "blog-like" page
with one that is more retrospective...so this page is being retired
to our off-line files as of 5 January 2005.
Since the vast majority of Anatomic Pathology is
practiced without FDA attention to details of methods, we are focused
on the totality of a process and not to focal FDA approvals or
non-approvals (although such FDA positions are noteworthy). To
give context, the FDA makes no comment or review of the way a physician
takes a medical history or performs a physical exam. Yet, Sir William
Osler would still tell the FDA and all others that...except for
the patient deciding to present for diagnosis and treatment...there
are no more important activities in behalf of patients in all of
the field of medicine than a "well performed" H&P!
Because our group/lab was immediately "under
attack" by ThinPrep sales reps & a few clinical physicians
in 2000 for not immediately switching to (though we were already
committed...had already had the instrument...to the AutoCyte methodology
for non-Pap specimens) ThinPrep when they came marketing to
Columbia, S. C., we decided to have a web page to keep our rationale
available within our lab & 8-pathologists of our pathology
group (and to our clinical physicians and their patients using
our services at Lexington Medical Center). We decided to keep,
and continue to update, this file as the criticism continues. Continuing
examples: Though our decision was made final some 4 years ago,
Cytyc (ThinPrep) won't leave our little niche alone & made
contact with some of our clients by passing out "standing
order" cards to physician offices for them to mail to labs
asking to only be provided with ThinPrep Pap test vials (2/25/04).
Chillingly, on 12/27/04, I was FedExed a threatening letter from "Deputy
General Counsel" for Cytyc demanding that this webpage be
removed from public (our clients are part of "public")
view by 4 January 2005 or risk legal remedies in favor of Cytyc.
This letter came without any contact ever from Cytyc, itself, expressing concern
or making any request to link to a similar but alternative and
opposing expression of opinion. So, as of 12/27, I am not totally
sure that this letter expresses the true position on the part of
Cytyc. It is hard to believe that (in a world of professional societies,
published expert literature, and experts ready and willing to give
expert advice for decision making) that the opinion of our small,
very locally focused practice would be seen as so threatening that
they would threaten us with the possibility of unlimited legal
action if we did not remove our opinion from view.
Though we continued to show that our data on a greatly decreased
volume of conventional Pap smear cervical cytology is equal to
or better than "thin layer" (not really monolayer), liquid-based
technology (because, regardless of whether Paps were a money maker,
we have always treated them with a full-court press mentality),
we have acquiesced to market demand & certainly admit that
liquid-based preps have screening advantages. We have offered liquid-based
Paps in our lab as of the summer of 2001 (having referred the samples
elsewhere beginning in 2000)...we got an "SUV" (liquid
based methodology) to supplement our "family vehicle" (conventionals).
Our internal QA data had shown our conventional work to be excellent,
and we were content. ThinPrep marketing came into our area (Spring
of 2000) and expertly converted the clinical physician market from
contented...to "wanting"...to "needing" liquid-based
cervical cytology Paps. Of the two competing brands, we picked
the SUV "with 4-wheel drive"...we did not want the "2-wheel
drive" brand, regardless of what was or was not published "in
the literature" as of early 2000.
Looking back, we admit that the thin-layer cellular presentation
is "cleaner", thereby reducing the "fret factor" in
the cytotechnologist's slide screening process.
Four years ago (1997) [check history],
and to this date, our due diligence evaluation indicates what we
believe to be distinct advantages of SurePath (AutoCyte) (TriPath
Imaging...TPTH) over ThinPrep (Cytyc
Corp....CYTC). There is no financial advantage, either
way, to our pathologists (and we are not in any way
beholding to any vendor, by personal ties, provision of "loaner" instruments
or equipment, "professional speaker" relationship, or
any other factor which would keep us from being strictly objective
in our decision in favor of the "4-wheel drive brand").
TriPath is so named because it consists of (1) the SurePath (AutoCyte) cytology
prep system, (2) the acquisition of the old, proven NeoPath computerized
screener system, and (3) the acquisition of the old PapNet computerized
screener system. The choice of SurePath set us also in position
to equip our "vehicle" with "airbags": the
FocalPoint supplemental computer screening of all cases (we began
this in 9/01).
Caution: sales reps, clinical doctors, and many
technologists & pathologists fail to keep their eyes on the
precise characteristics of: the (1) clinical strategy for choosing
the test method in question (Pap smear...and, for example, never
miss an invasive cancer vs. the greatest sensitivity for LGSIL);
(2) therefore, the particular "gold standard" for looking
at sensitivity, specificity, and predictive values (biopsy vs.
PCR, etc.); (3) and therefore, the prevalence of the particular
disease of most importance (ca/HGSIL vs. ASCUS/LGSIL). So, choices
could vary, depending on the game plan of the cytopathology lab.
- As to the clinical physician's
- the neutral ACOG position: ACOG, in a 27 July
2001 e-mail to us, confirms that Committee Opinion #206
was withdrawn Dec., 2000, and that not enough data
existed/exists for an opinion on conventional vs. thin
layer, much less ThinPrep vs. SurePath (AutoCyte). The
ACOG update of Dec. 2002 & Opinion of August 2003 remains
neutral as to vendor8.
- the Liquid-based advantage of better sensitivity
for dysplasia: at least in other labs, many reports
indicate (as of early 2001) that liquid-based thin-layer
techniques increase the yield of LGSIL and HGSIL
by significant margins over conventional techniques (could
this be more a recent result of a combination of [a]
the intense marketing discussions and educational focus
on the fundamental need for the clinicians to take care
to obtain adequate samples; and,
[b] the reduction...in the production-quota labs...of
the cytotechnologist "fret factor" as they
now screen "cleaner" smears?)7.
- Adequacy & reduced "call
backs": SurePath (AutoCyte) and our conventional
Paps reduce call backs for reasons of "inadequate" or "less
than optimal" specimens2-5...especially
as to S-C junction sampling...SurePath having 5 times2 less
call backs than ThinPrep.
- Bleeding at office visit: No problem...SurePath
(AutoCyte) works the best of the two methods with bloody
and/or mucoid specimens...the CytoRich media lyses RBCs
and does not "clot" mucous (greatly reduced "call
backs" due to obscuring blood due to inadvertent
menses at time of Pap); ThinPrep has to go around their
FDA-approved process and ask labs to pre-process the specimen
to lyse blood. RBC lysis removes the obscuring by the dense
red color. But, the mucous and RBC membranes tend to clog
the ThinPrep filter; whereas this is not a problem with
the SurePath gradient enrichment
- SurePath (AutoCyte) smear taking is quick: their "Rover
Cervex-Broom" single-pass collection device is better and "thumbs
off" into the liquid container (ThinPrep, by FDA,
must obtain two samples,
1 by brush & 1 by spatula); (but our clinicians
correctly point out that the Cervex-Broom cannot be flexed
into an anteverted uterine cervix...so, they can use a
supplemental endocervix brush & detach the brush end
into the fluid); and,
- Better SurePath sample integrity: this means 100% of
a statistically better cell sample actually goes to the
lab (ThinPrep sends less than 100% unless you go outside
of their FDA-approved process with time consuming supplemental
- Superior invasive cancer, cell-clusters, and small-cell
detection: SurePath (AutoCyte) better than ThinPrep
at detecting cell clusters (postmenopausal endometrials,
small cell carcinoma & AGUS) & concern for suboptimal
detection of invasive cancer1 and ThinPrep
no better than conventional at detecting invasive cancer7...reduced danger
to patient and clinician of "failure to diagnose".
false-negative rate (missing important
diagnoses) is twice that of SurePath (AutoCyte)
and much higher than our own conventional Paps...SurePath
has reduced danger
to patient of "failure to diagnose" [a
50,000+ case study published late 2001].
By 2002, reports can be interpreted with concern
that ThinPrep filter clogs with tumor diathesis debris
to the point that may fail to produce diagnosable
slide preps of frank cancer1,7!!!
- HPV: SurePath (AutoCyte) HPV yield better
than ThinPrep yield of HPV positivity on referral testing
(ThinPrep brush not FDA approved for HPV sampling) and
is just as good as a second patient encounter specifically
just to get an HPV sample.
- adding "airbags": our lab (contract
signed 11 Oct. 2001) also added SurePath (AutoCyte) companion
computer screener, AutoPap (FocalPoint) , so that all Pap
smears [as of August 2002] are afforded (1) expert
cytotechnologist manual screening plus (2) computer-aided
screening (as our radiologists are also doing with mammograms
via the R2). AutoPap/FocalPoint (prior NeoPath) is the
only FDA-approved device for conventional Paps and SurePath
(AutoCyte) Paps (not ThinPrep). In a study
(Acta Cytol. 45:704-708, 2001) of 14,777 conventional Paps,
AutoPap (FocalPoint) sorted 100% of abnormal Paps
into the quintiles that definitely needed focused
human review (giving a screening "heads up" to
the screening cytotechnologist). Cytyc got FDA approval
for a competitor computer screener, the ThinPrep Imager
System, July 2003.
- For the lab and hospital:
- general cost per case payment to "the company" is
significantly less with SurePath (AutoCyte).
- SurePath (AutoCyte) allows walk-away staining of slides;
ThinPrep requires more prep-tech time per case.
- SurePath (AutoCyte) reagent-rental structure ensures
an easy, open-door addition of upgrades (no future "capital
- CytoRich® ethanol-based liquid is non-flammable except
at high temperatures & lyses
obscuring blood (ThinPrep's PreservCyt carries
a flammable label & does not lyse blood).
- ethanol-based cell fixation by SurePath (AutoCyte) is
the same fixation as in our conventional technique (makes
cells/nuclear structure "look" similar to what
we have always been used to in cytopathology).
- ThinPrep users must go outside of ThinPrep's FDA approved
methodology to try to clear obscuring red cells and to
present 100% of sample to lab.
- SurePath (AutoCyte) ethanol-based liquid DOES
NOT clot or precipitate mucus and red cell membranes (which,
due to their methanol-based liquid, clogs the ThinPrep
filters & impairs relative efficacy).
- SurePath (AutoCyte) robotic aspiration-expression, back & forth
syringe manipulation of the collected specimen to disaggregate & homogenize
the sample, allows a representative aliquot of sample to
be deposited into the centrifuge tube over the density
gradient material/jell. The homogenized cell solution
is then pulled through a density gradient using centrifugation
to remove obscuring artifacts. A robotic processor then
places the jell-filtered cell solution onto a lyseine-coated
slide for gravity sedimentation enrichment as the suspended
cells settle and attach to the slide surface by way of
the "charged" slide surface; this enriched smear
prep is better than cloggable suction-filter touch prep
method of ThinPrep.
- much better residual specimen for HPV/STD tests out of
the single patient encounter (all of which tests will be
managed and offered "in house, on campus" at
our hospital as of March 2003).
- Additional Crucially Important
the THREE vastly more
important factors (rather than which technology or brand
name) in the effort in behalf of women against uterine
cancer are being regularly overlooked in the heat of
- a higher percentage of women must be recruited
to regular Pap screening.
- clinical doctors must do their best to get the
best sample from the cervix
- labs must employ, compensate, and lead competent
cytotechnologists who can screen and find the abnormalities
- SurePath (AutoCyte) came second (6/1999 for Pap
smears) to market (ThinPrep thereby gaining the lead in
name-brand recognition) after ThinPrep (5/1996), because:
- Cytyc sued TriPath (delaying market entry) for
patent infringement.....and lost; and,
- the FDA required added studies that they had not
required of Cytyc...delaying TriPath until 6/99.
- ThinPrep 2000-2001 Cytyc sales rep marketing ploy: "Trident
Hospital lost all of its Pap business because they got
SurePath (AutoCyte)!" A lie...they lost a large account
because of hospital administrative conflict
with that clinical practice.
- ThinPrep 2000-2001 marketing ploy: Orangeburg OB-Gyns
want ThinPrep so bad they are sending specimens to LabCorp
as of 7/30/01...not true.
- ThinPrep 2000-2001 marketing ploy: local area LabCorp
has both SurePath (AutoCyte) and ThinPrep instruments as
of 2001...a lie.
- Fact: S. C.'s DHEC is poised to use two SurePath (AutoCyte)
as soon as budget is approved as of 2001 (as of end of
2003, no liquid based yet).
- we've been in touch with numerous ThinPrep labs who are
going to convert to SurePath (AutoCyte) (as of 2002).
- Cytyc Corp (ThinPrep) is a publicly traded company with
Quest Diagnostics, Inc. being a huge stock owner through
an agreement to exclusively use ThinPrep brand of liquid-based
Pap technology. TriPath Imaging is a publicly traded
company with major share holders being Roche Laboratories,
Inc. and Becton-Dickinson, Inc.
- One of our excellent OB-Gyns pushing for ThinPrep told
us on 1 Aug. 2001, "I haven't had any adequacy problems
with my ThinPrep cases. Any that were inadequate or less
than optimal had reasons why" [is this "taking
a position" on the basis of a small and private study?].
So, we studied (in-house QA) a 250+ case series of his Paps...his "less
than optimal due to insufficient endocervical component" rate
was 300% higher with ThinPrep than with conventional (7
Aug. 2001)!!!!! Can clinicians remain objective about lab
- We continue to be astounded at the "sore
loser" attitude of Cytyc marketing as they hysterically
commandeer the valuable time of our busy clinicians,
even though our hospital has contracted for, and taken
delivery of , the SurePath (AutoCyte)!!! Beyond that,
rumor from Cytyc rep has it that the decision was in
favor of SurePath (AutoCyte) because of our hospital
Lab vendetta (Oct. 18th, 2001 rumor) against ThinPrep.
Re-read this page and show us the evidence against the
fact of the decision being strictly as to our assessment
of what will be the greatest help and advantage (we aren't
vendetta people) to patients.
- ASCUS rate: With any change to interpretation
of liquid-based preps, there is a break-in period during
which the lab team will have an increased ASCUS rate. By
directorate fiat (you are fired if your ASCUS rate is higher
than ___%), we could dictatorially reduce that rate (but
don't direct our lab in that manner). Though being highly
sensitive to clinician chart backlog caused by ASCUS cases,
we must keep our prime focus on avoiding any "failure
to diagnose" important lesions. We continue to press
to reduce the ASCUS rate.
SB, et. al., Invasive Squamous Cell Carcinoma in ThinPrep
Specimens: Diagnostic Clues in the Cellular Pattern, Diagnostic
Cytopathology, 26:1-4, 2002 (Cleveland Clinic...study of
13 SCC cases).
KV, SurePath vs. ThinPrep in a Low Prevalence Population,
Acta Cytologica 46:953, 2002.
KV, Conversion from ThinPrep to SurePath: How to Validate,
Acta Cytologica 46:952, 2002.
DR, Comparison of the Detection Rate of Pap Abnormalities
in Autocyte Prep and ThinPrep Pap Test Specimens, Acta Cytologica
Impact of Converting ThinPrep to SurePath on Overall Sensitivity
and Adequacy, Acta Cytologica 46:958, 2002.
KV, their lab's (Rex Health Care, Raleigh, NC) Nov. 2002
newsletter, at the American Society of Cytology annual meeting,
2002, Salt Lake City, Utah.
A, et. al., Comparative Analysis of Conventional Pap. Tests
and a Fluid-based Thin-layer Method, Archives of Path. and
Lab. Medicine, Feb. 2003. (1.4 million cases, Quest Labs,
Teteroro, N. J.)
Technology Assessment in Obstetrics and Gynecology: Cervical
Cytology Screening, #2, Dec. 2002.
DR, Comparison of the False Negative Fraction in Autocyte
Preps, ThinPrep Pap Tests, and Conventional Pap Smears,
[posted 19 July 2001; latest addition 5 January 2005]