In the mid 1990's, we started investigating liquid-based technology. Cytyc's Thin-Prep method was the only FDA-approved liquid-based technology for Pap smear testing at that time. We, like many others, were not convinced that this new, more expensive type of processing offered a significant improvement in disease detection over the conventional pap smear. But being forward-thinking, we felt we owed it to our patients and clinicians to give the concept of liquid-based, thin-layer processing a thorough review.

We were one of the first groups in South Carolina to bring in a thin-layer instrument on a trial basis. In 1997, we arranged to have the AutoCyte Prep system brought in for the purpose of processing non-gynecologic specimens. (At that time the system was FDA-approved for non-gyns only, but was under consideration for approval for Pap smear processing.)

We used the AutoCyte for non-gyns but soon found that, while the preparations were spectacular in quality, our policy of meeting the rapid turnaround demand for non-gyn results was difficult to accomplish. Because we did not want to delay non-gyn specimens to be batch processed, it was not realistic for us to continue using the AutoCyte. We were, nevertheless, extremely impressed with the vendor support, ease of processing, and the beautiful preparations. Cytotechnologists microscopically scan Pap preparations by the "random meander" technique of visually "scribbling" around the cell spread in an non-repeatable pattern until the entire surface area of the spread is seen. The smaller & "cleaner" liquid based preparations promised to cut the screening surface area into half or a third of the conventionals...but at a significant cost increase. Because of the intuitive logic of the techniques involved, we envisioned that the AutoCyte could be an acceptable alternative to the standard Pap at some time. Conventional Pap processing, however, remained our method of choice for the time being.

Then the Cytyc reps came calling in 2000! They had launched a major marketing effort in central and coastal South Carolina. Their hard-ball approach to sales is legendary, many such experiences having recently been related via the ASC list-serve. Despite their aggressive marketing, we were very skeptical that the ThinPrep method would be significantly superior to the conventional smear method. We had a pretty good batting average with the old method and could not justify using a more costly test that we quickly thought had some inherent processing problems. We remained uncommitted to either thin-layer methodology.

Because we did not immediately jump on the ThinPrep bandwagon, Cytyc's next rapid approach was to go directly to our clinicians with declarations as to how we (the lab) and they (the OB-GYNs) were placing their patients in jeopardy by not switching to ThinPrep. We frankly resented this outright denigration of our ability to make reasoned decisions as to the appropriate use of any (new or standard) technology for our particular situation.

Eventually, some of our clinicians were convinced that perhaps the ThinPrep should be given a try. In an effort to accommodate their wishes, in the fall of 2000, we sought the services of one of the most prominent ThinPrep-using laboratories in our state, Coastal Pathology Laboratories in Charleston, South Carolina. Dr. Marshall Austin, who was a well-known cytopathologist, a current president of the American Society of Cytopathology, and out-spoken proponent of Cytyc products was the laboratory director. We felt that there could be no better choice of reference labs for those of our clients who wanted to use the ThinPrep method. We continued to process conventional paps at our lab.

As the pap results came back from Charleston to be forwarded to the clinicians, we were able to archive the findings and compare them to the follow-up biopsies, which were still being sent to our lab for evaluation. We could not verify through our internal data comparisons that the ThinPrep showed any improvement in disease detection over the conventional pap. And, indeed, data showed an increase in the rate of "less than optimal" specimens. Therefore, we said that we would wait on AutoCyte FDA approval.

Our "little study" was, of course, ridiculed verbally by the Cytyc rep as not being of substantial volume. Cytyc's mantra at the time was that there were no "head to head" or published comparisons of the ThinPrep and AutoCyte methods. Well, of course not! How could there be when the FDA had only the year before approved the AutoCyte for Pap smear testing! One would not expect to find much published literature about AutoCyte until the methodology had become widely used. To our way of thinking, ThinPrep was just the first, not necessarily the best. (Since that time, Dr. David Bolick [formerly of Reference Pathology Services Laboratory and Ameripath Labs in Sandy, Utah and then with Grant Life Sciences] has done a rather large ThinPrep/AutoCyte comparison. The Reference Pathology Services web site on which he posted it is no longer accessible but we do have copies of his study.)

By the beginning of 2001, the "market place had spoken"; and the demand for on-site thin-layer processing increased. It became evident that we needed to offer the option of one or the other of the new technologies. Our challenge was to find out all we could about both thin-layer methods. There ensued a lengthy and comprehensive evaluation of both companies and products. We searched the internet and professional journals. We talked to ThinPrep users and to folks that were in the process of evaluating the AutoCyte. We communicated with the American College of Obstetricians and Gynecologists (ACOG) about their position on thin-layer technology. We took into consideration our experience with both vendors and their marketing and support methods.

Relying on this information and our gut feeling that AutoCyte (SurePath) offered the best all around advantage to our clinicians, patients and laboratory, we decided to implement that system in July of 2001. We had also heard that TriPath was working on an automated screener that could handle both AutoCyte and conventional slides. Having recently moved into a larger work area and having increased both our caseload and personnel, we were then in a better position to undertake this change.

We have used the SurePath method continuously since that time and are still very satisfied with the results and the vendor. We have not received any special incentives from TriPath nor do we have a vendetta against Cytyc as some have claimed. We simply did not follow Cytyc's agenda or cave in to their marketing practices.

Our refusal to "comply" has had some negative consequences. Cytyc continued for quite a while to try to sway our clinicians by verbally casting doubt about our judgment. This is, of course, their right to do in a free society.

Yet, when we seek to tell our side of the story, Cytyc's attorney demands in writing that we, a small South Carolina pathology group, "cease and desist" from publishing our opinions on a web site which was created to keep our group and our clients informed. Cytyc then no longer contacted us except through their deputy general counsel with letters threatening litigation.  This is in keeping with their reputation of a heavy-handed approach to obliterate any opposing viewpoints. We wonder how many other laboratories or pathology practices have received such threats. A more acceptable approach would have been to have someone in their marketing department call and ask us to provide links to alternative, more Cytyc-friendly viewpoints and experiences.

We, like other followers of the ASC List-serve, were appalled in 2004 at Cytyc's issuance of the notorious "standing order" cards to physicians' offices. These cards were to be sent by the physicians to our labs asking that labs provide only ThinPrep vials for pap collection. That tactic moved even Cytyc proponents to question the company's ethics. All of our clients who had been having their cases sent out for ThinPrep testing have since returned to us.

Let's back up a moment and look at some facts. From 1989 to 1994, James Linder, M. D., was chairman of the FDA Hematology and Pathology Devices Panel. This panel reviews Pre-Market Approval (PMA) applications for medical devices. The FDA received Cytyc's PMA application in November, 1995; and the ThinPrep 2000 was approved six months later in May of 1996. Interestingly, Dr. Linder joined Cytyc in 1995 as a consultant and became the Medical Director in 1996. AutoCyte submitted its PMA application in May, 1997. The AutoCyte Prep system received approval two years later in June of 1999.

After the FDA approved the ThinPrep 2000 for commercial use in 1996, a citizens petition was filed with the FDA in 1997 raising many questions and concerns, including the labeling that was allowed for ThinPrep. After review of the petition, the FDA stood by its initial approval and initial labeling of the Cytyc product.

Shortly before the citizen's petition for a request of FDA review of the ThinPrep labeling, AutoCyte had submitted it's PMA for the AutoCyte Prep system. During the final labeling discussions for the PREP product, the FDA stated that PREP, or any other similar product, would not be allowed to have a summary statement in it's final Product Insert even though Cytyc did and still does (as of 2005). (See product inserts for both ThinPrep and SurePath.)

Such great controversy arose over the labeling issue, that Dr. Steven I. Gutman, (Director of the FDA's Division of Clinical Laboratory Devices Office of Device Evaluation) felt he should clarify the FDA's position in a letter to the Editor of Acta Cytologica (2000;44:1120). We also have a copy of a letter Dr. Gutman wrote in response to a clinical laboratory's inquiry regarding marketing claims by manufacturers of cervical cytology devices. In it he states: "As a part of their approval, both companies [Cytyc and TriPath] had to conduct clinical studies at multiple sites and present the results of these studies in their labeling for the benefit of the device users. This is intended to give users an overview of the performance that can be expected under the conditions of a defined clinical study for a particular device. In one such study, the device was shown to provide a statistically significant difference at three of the six test sites. While the difference was allowed to be noted in the labeling, FDA never intended that thus (sic) would constitute superior performance." He ends the letter by stating "The Agency has not done any comparative testing of the devices to assess performance and does not provide an endorsement of one device over another."

Here are the conclusions and opinions we have drawn based on:

1. Our situationally biased interpretation of journal articles, published abstracts, posters presented at the American Society of Cytopathology (ASC) annual meetings, topic discussions (e-mails) posted on the ASC List-serve, and various internet postings.
2. Our own internal studies and those shared with us by other select laboratories.
3. Direct in-person and telephone communication with ThinPrep and SurePath users.
4. Our own experience with Cytyc and TriPath.

• The neutral ACOG position: ACOG, in a July 2001 e-mail to us, confirms that Committee Opinion #206 was withdrawn December, 2000 and that not enough data existed/exists for an opinion on conventional vs. thin-layer, much less ThinPrep vs. SurePath (AutoCyte). The ACOG updates of December 2002, July 2003, and Practice Bulletin Number 45 of August 2003 remain neutral as to vendor.

Note: Cytyc alleges in their December 20, 2004 letter to Dr. Shaw that he has made a "false and misleading claim [that ACOG is neutral as to the ThinPrep Pap Test]. The Cytyc attorney goes on to say. "yet the article clearly points out that the FDA has reviewed both the ThinPrep and SurePath liquid-based systems and has allowed the ThinPrep Pap Test to be marketed as better able to detect both low-grade and high grade squamous intraepithelial lesions.while only allowing the SurePath system to be marketed as equivalent to the conventional Pap test. "

In our opinion, the Cytyc attorney misconstrues a simple statement on page 6 of the Practice Bulletin (No. 45) as an endorsement of ThinPrep. The actual wording of the statement is as follows: "According to FDA-required labeling, the ThinPrep technique may be marketed as better able to detect LSIL and HSIL than the conventional Pap test, and the SurePath technique may be marketed as equivalent to the conventional Pap test (17)." This is merely a statement of the exact labeling, not intended to impart any favoritism. In fact, if one proceeds to page 8 of the same bulletin, under "Summary of Recommendations" you will see the following statement: "Evidence-based data indicate both liquid-based and conventional methods of cervical cytology are acceptable for screening." How much more neutral can they be?

• the Liquid-based advantage of better sensitivity for dysplasia: In our lab and in other labs, studies indicated that liquid-based thin-layer techniques increase the yield of LGSIL and HGSIL by significant margins^1-16 over conventional techniques. Could this, rather, be a more recent result of a combination of:
  1. the intense marketing discussions and educational focus on the fundamental need for the clinicians to obtain adequate samples; and,
  2. the reduction in the production-quota labs of the cytotechnologists' "fret factor" as they now screen "cleaner" smears?

Recently, the FDA allowed SurePath to include labeling that reports a 64.4% increase in HSIL+ disease detection. ThinPrep's HSIL+ detection rate is 59.7%. (See Product inserts.)

• Adequacy: SurePath has been shown by our lab and others to provide increased adequacy ^17-19,27 and a more cellular sample ^18-20 with fewer limiting factors than ThinPrep. In our lab, very few SurePath preps have to be reprocessed to yield an acceptable result.
• Bleeding/menses at office visit: SurePath works well with bloody and/or mucoid specimens.the CytoRich media lyses RBC's and does not "clot" mucous. This translates to fewer patient call-backs due to menses. Bloody specimens are known to clog the ThinPrep filters²⁶, sometimes keeping significant diagnostic cells from being transferred to the slide.^21-27 A non-FDA approved method of treating bloody ThinPrep samples with glacial acetic acid is often used in order to lyse the red cells. Mucous clots add a disadvantage of "taking up space" to exclude some degree of cellularity.
• SurePath (AutoCyte) sample taking is quick: The "Rovers Cervex-Broom" easily "thumbs off" into the vial. Brush/spatula devices are now approved for use with SurePath.²⁷ Those tips are also manufactured to separate easily for deposit into the collection container (we carry about 6 different acceptable devices).
• Better sample integrity: It should be noted that both ThinPrep and SurePath now have approval to use the broom and/or brush/spatula devices.  Because the whole SurePath collection tip goes into the vial³⁰ ,100% of a statistically better cell sample actually goes to the lab. ThinPrep collection devices are only swished into the preservative and then discarded.
• Superior invasive cancer, cell clusters, and small-cell detection: SurePath better than ThinPrep at detecting cell clusters (postmenopausal endometrials, small cell carcinoma and AGUS). ^{3,5,9-16,21,22} There is concern for suboptimal detection of invasive cancer with ThinPrep.^21,22 ThinPrep is no better than conventional at detection of invasive cancer.¹⁵ ThinPrep's false negative rate (missing important diagnoses) is twice that of SurePath in a study conducted by Dr. David Bolick in 2001.⁵
• HPV: SurePath HPV yield is slightly better than ThinPrep yield of oncogenic HPV positivity on referral testing.³¹ Contrary to what many people believe, it does not matter that ThinPrep is the only liquid-based pap test that has been FDA-approved for HPV testing. As long as a laboratory conducts its own ASR-type validation test, SurePath can safely be used for HPV testing by either the Digene HC method or by the in situ hybridization method. Many laboratories, including our own, have done this and perform HPV testing on SurePath samples on a regular basis.
• Computerized Screening: In August, 2002, our lab began using the FocalPoint automated slide screener so that ALL Pap smears are afforded computer-aided screening as well as expert cytotechnologist screening. The Focal point is the only automated screening device that is approved for both conventional and liquid-based (SurePath only) paps. In a study published in Acta Cytologica, Vol 45:704-708 in 2001, of 14,777 conventional paps, the FocalPoint sorted 100% of the abnormal paps into quintiles that definitely needed focused human review. This instrument is one additional safe-guard for our patients. Cytyc received approval for their imaging system in July, 2003.the Cytyc Imager only screens ThinPreps.

  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.
• SurePath (AutoCyte) reagent-rental structure ensures an easy, open-door addition of upgrades (no future "capital budget" hurdles).
• 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 seen in all of cytopathology).
• ThinPrep users must go outside of ThinPrep's FDA approved methodology to try to clear obscuring red cells and mucous which clog the ThinPrep filter pores. This adds to laboratory time cost, especially.⁵⁰
• 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 liquid. The homogenized cell solution is then pulled through the density gradient using centrifugation to remove or lessen obscuring artifacts. A robotic processor then places the gradient-filtered cell solution onto a lysine-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 the cloggable suction-filter touch prep method of ThinPrep.²⁶
• ThinPreps have been noted to cause an artifact mimicking HPV changes.^34,35,37
• Ample 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).
• Possibility of cross-contamination with ThinPrep specimens.²⁸

  Additional Crucially Important Summary Information:

• Unfortunately, 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 marketing battles:
  1. a higher percentage of women must be recruited to regular Pap screening; and,
  2. clinical doctors must do their best to get the best sample from the cervix; and,
  3. 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 after ThinPrep (5/1996). ThinPrep gained the lead in name-brand recognition. For years, many physicians and laboratorians confused the brand name "ThinPrep" with the methodology term "thin-layer." That actually was quite clever marketing. Some issues that may have contributed to SurePath's late start are:
  1. Patent infringement lawsuits [societal adverse impact of such lawsuits] launched by Cytyc against TriPath. These were settled in January, 2001 without admission of liability by either party.
  2. The FDA required additional studies for the AutoCyte review...delaying TriPath approval until 6/99.
• In 2001, a Cytyc rumor circulated that "XXX Hospital in North Charleston [South Carolina] last year made a decision to go to AutoCyte over ThinPrep, and they have now lost enough OB-GYN business that they are losing cytotechnologists." The truth is...they lost a large account because of hospital administrative conflict with that clinical practice.
• We are aware of numerous ThinPrep labs who have converted or are going to convert, to SurePath (AutoCyte).
• We continue to be astounded at the "sore loser" attitude of Cytyc marketing as they take up the valuable time of our busy clinicians, even though our hospital has contracted for, and taken delivery of, the SurePath (AutoCyte)!!! Beyond that, a rumor from a Cytyc rep had it that the decision was in favor of SurePath (AutoCyte) because of our hospital Lab's alleged vendetta (Oct. 18th, 2001 rumor) against ThinPrep. While we do not agree with Cytyc's marketing practices, we certainly do not have the time or inclination to pursue a "vendetta."
• Dr. Stephen Black-Schaffer at Massachusetts General Hospital reported similar Cytyc "account recovery" maneuvers in his article in Clinics in Laboratory Medicine (2003) pages 681-694. In it he speaks about receiving concerned communications from members of the medical staff upon their decision to switch to Method 2 [a.k.a. SurePath] from Method 1 [a.k.a. ThinPrep]. The medical staff members had been told by representatives of Method 1 that the decision to switch to Method 2 was based on "financial considerations without regard for quality of care⁴¹".

References:

1. SurePath 64.4% increased detection of HSIL+ (See Product Insert) (FDA approved expanded labeling May, 2004) ThinPrep 59.7% increased detection of HSIL+ (See Product Insert)
2. Cibas, ES and Ducatman, BS, Chapter on Cervical and Vaginal Cytology, Cytology: Diagnostic Principals and Clinical Correlates, 2^nd ed. Philadelphia, 2003, p. 5
3. Bolick, DR, Comparison of the Detection Rate of Pap Abnormalities in AutoCyte PREP and ThinPrep Pap Test Specimens. Poster Presentation at 49^th Annual Meeting of the American Society of Cytopathology, November, 2001.
4. Nance, KV, Conversion from ThinPrep to SurePath: How to Validate. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
5. Bolick, DR, Comparison of the False Negative Fraction in AutoCyte Preps, ThinPrep Pap Tests And Conventional Pap Smears. Poster Presentation at 49^th Annual Meeting of the American Society of Cytopathology, November, 2001.
6. Nance, KV, SurePath vs. ThinPrep in a Low Prevalence Population. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
7. Fite, SK , Do SurePath and ThinPrep Increase Sensitivity at the Expense of Specificity? An HSIL Biopsy Correlation Study. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
8. Bolick, DR, Frequency of Negative Pap Specimens Taken Prior to Biopsy Proven Cervical Intraepithelial Neoplasia. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
9. Renshaw,, AA et al, Comparison of Performance of Conventional and ThinPrep Gynecologic Preparations in the College of American Pathologists Gynecologic Cytology Program. Arch Pathol Lab Med, Vol 128, January, 2004. p. 17-22.
10. Volk, EE, Error Rates: ThinPrep vs. Conventional Paps, CAP Today, May 2004
11. Clark, SB et al, Invasive Squamous-Cell Carcinoma in ThinPrep Specimens: Diagnostic Clues in The Cellular Pattern, Diagnostic Cytopathology, Vol. 26, Issue 1, p. 1-4.
12. Auger, M et al, The ThinPrep Pap Test: Clinical Comparison in a High-Risk Population. Poster Presentation at 49^th Annual Meeting of the American Society of Cytopathology, November, 2001.
13. Marshall, CJ et al, Does the ThinPrep Pap Test Improve False Negative Rates Due to Detection Error? Poster Presentation at 49^th Annual Meeting of the American Society of Cytopathology, November, 2001.
14. Islam, S et al, Reprocessing Unsatisfactory ThinPrep Papanicolaou Test Specimens Increases Sample Adequacy and Detection of Significant Cervicovaginal Lesions. Cancer. 2004 Apr 25;102(2):67-73.
15. Cheung, A. et al, Liquid-Based Cytology and Conventional Cervical Smears, a Comparison Study in an Asian Screening Population. Cancer Cytopathology. Vol. 99, No. 6, p.331-335. December 2003.
16. Tench, W., Preliminary Assessment of the AutoCyte PREP Direct-to-Vial Performance. The Journal of Reproductive Medicine. Vol. 45. No. 11, November 2000.
17. Fremont-Smith, M. et al, Comparison of the SurePath Liquid-Based Papanicolaou Smear with the Conventional Papanicolaou Smear in a Multisite Direct-to-Vial Study. Cancer. 2004 Oct. 25; 102(5):269-279.
18. Sass, M A, Use of a Liquid-Based, Thin-Layer Pap Test in a Community Hospital Impact on Cytology Performance and Productivity. Acta Cytologica 2004 Jan-Feb;48(1):17-22.
19. Duch, J et al, Follow-Up Correlation of Abnormal SurePath Pap Results. Poster Presentation at 52^nd Annual ASC meeting, November 2004.
20. Andy, C et al, Is the ThinPrep Better than the Conventional Pap Smear at Detecting Cervical Cancer? The Journal of Family Practice. April 2004. Vol. 53, No. 4.
21. SurePath 58.4% Decrease in Unsats SurePath: Product Insert, page 6. ThinPrep Cumulative 55% reduction in "Satisfactory but limited by" but no difference in Unsatisfactory rate. (Refer to ThinPrep Product Insert) Summary of Clinical Data. Cytyc Corporation
22. Bolick, DR, Comparison of Cellularity of SurePath and ThinPrep Pap Test Specimens. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
23. Fite, SK. Impact of Converting ThinPrep to SurePath on Overall Sensitivity and Adequacy. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
24. Bolick, DR, Data on Liquid Base Preparation Cellularity. (Summary of studies) Message posted on ASC List-serve, October 23, 2003.
25. McDermott, J, Comment on decreased Unsatisfactory Rate by SurePath. Message posted on ASC List-serve, February 27, 2004.
26. Nance, KV. Comment on Unsatisfactory ThinPreps. Message posted on ASC List-serve. March 25, 2004.
27. Degener, DF, Handling of Bloody Samples with Liquid-Based Preparations. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
28. Michael, CW et al, Comparison of ThinPrep and TriPath PREP) liquid-based preparations in Non-gynecologic specimens: A pilot study. Diagnostic Cytopathology. Volume 25, Issue 3, Pages 177-184.
29. Bentz, JS et al, The Unsatisfactory ThinPrep Pap Test: Missed Opportunity for Disease Detection. Am J Clin Pathol 117(3):457-463, 2002.
30. Hecht, SA et al, Comparison of Methods for Reprocessing Bloody Gynecological Specimens in PreservCyt Solution. Poster Presentation at 52^nd Annual ASC meeting, November 2004.
31. Sweeney, BJ et al, Comparison of the Effectiveness of Two Liquid-Based Pap Systems in the Handling of Adverse Limiting Factors Such as Excessive Blood and Inflammation. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
32. McGrath, CM, Comparison of Cytologic Preparations in Cervicovaginal Cytopathology: Conventional vs. ThinPrep vs. AutoCyte PREP. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
33. Bolick, DR, Comment regarding cross-contamination with ThinPrep specimens. Message posted on ASC List-serve, February 17, 2004.
34. Kenyon, S et al, Comparison of SurePath and ThinPrep Pap Systems in the Processing of Mucus-Rich Specimens. Poster Presentation at 52^nd Annual ASC meeting, November 2004.
35. Premarket Approval Decisions for May, 2004.  FDA approves expanded labeling claims for SurePath Liquid-Based Pap Test. TriPath Imaging Receives FDA approval for Expanded Labeling for SurePath Liquid-Based Pap Test.
36. Bigras, G. et al, Keeping Collecting Device in Liquid Medium is Mandatory to Ensure Optimized Liquid-Based Cervical Cytology Sampling. Journal of Lower Genital Tract Disease. 7(3):168-174, July, 2003.
37. Rinas, AC, et al, Split Sample Analysis of Throw Away Cells from ThinPrep Pap Smear Sampling Devices. Poster Presentation at 52^nd Annual ASC meeting, November 2004.
38. Bolick, DR, Comparison of the Detection Rate of Human Papillomavirus in AutoCyte Prep and ThinPrep Pap Test Specimens. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
39. Degener, DF, Reflex HPV Testing on ASCUS Paps Using ThinPrep and SurePath. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
40. Spangler, F, Preservation of Chlamydia trachomatis and Neisseria gonorrhoeae DNA Stored in SurePath PAP Media for PCR Testing on the Roche COBAS Amplicor. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
41. Morrison, C et al, Oral contraceptives are associated with artifacts in ThinPrep Pap smears that Mimic low-grade squamous intraepithelial lesions. Cancer Cytopathology, Volume 99, Issue 2, Pages 75-82. Published Online 12 December 2002.
42. Nuovo, G. Interview with Dr. Nuovo on OBGYN.net. Comments indicating that ThinPrep artifacts may have lead to women being told they had a venereal disease when they really didn't . Article entitled "Testing method may Be culprit behind abnormal pap results.
43. Bolick, DR, Chlamydia trachomatis and Neisseria gonorrhoeae from the AutoCyte Pap Vial, Using Polymerase Chain Reaction (PCR).
44. Babb, M et al, Comparison of SurePath ASC-US Pap Tests with Conventional ASCUS Pap Smears: Follow-Up Correlation Using HCII HPV Testing and Biopsy Results. Poster Presentation at 52^nd Annual ASC meeting, November 2004.
45. Agoff, SN et al, The Efficacy of Reprocessing Unsatisfactory Cervicovaginal ThinPrep Specimens with and without Glacial Acetic Acid: Effect on Hybrid Capture II Human Papillomavirus Testing and Clinical Follow-up. Am J Clin Pathol. 2002 Nov;118(5):727-32.
46. Freund, GC et al, The TriPath Care Technologies FocalPoint Slide Imager is Very Effective at Identifying Abnormal GYN Cervical Cytologies Using SurePath Prepared Slides. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
47. Wilbur, DC et al, FocalPoint (formerly AutoPap) Screening Algorithms Show Robust Performance In Classification of High Grade Lesions on SurePath (formerly AutoCyte PREP) Liquid-based Cervical Cytology Slides. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002.
48. Hughes, T and Karados, T., Performance Characteristics of the FocalPoint Slide Profiler Examination with SurePath Pap Tests: Experience with 9,186 Cases with 100% Cytotechnologist's Review. Poster Presentation at 50^th Annual Meeting of the American Society of Cytopathology, November 2002
49. Black-Schaffer, W. S., Choosing Between Competing Technologies in the Cytology Laboratory. Clinics in Laboratory Medicine 23 (2003) p. 681-694.
50. Song, L H, et al, Technical Aspect of ThinPrep, Singapore Med J, 2000, Vol. 41(12): 575-578
51. Ten ASC Listserve Members comments regarding ThinPrep Standing Order Cards. Feb. 27, 2004.
    1. Paul A. Elgert, CT(ASCP), CMIAC, BTP, NYU School of Medicine, Bellevue Hospital Center.
    2. Keith V. Nance, MD, Rex Hospital, Raleigh, NC
    3. Bill Tench, MD, Palomar Medical Center
    4. Rosanna Clouse, SCT, The Gettysburg Hospital-Wellspan, Gettysburg, PA
    5. Scott E. Wang, MD, Newport, RI
    6. Michael J. Beckmann, D.O., Memorial Medical Center, Springfield, IL
    7. Sandra K. Fite, CT(ASCP), Delta Pathology Group, Shreveport. Louisiana
    8. Willie H. Cavett, Jr. (CT(ASCP), Methodist Medical Center, Dallas, TX
    9. John Baker, MD, University of Nebraska
    10. Jick Wong, MS, CT(ASCP), University of Texas Medical Branch, Galveston, TX