Message from Dr. Eva Wocjik, the ASC President

It is my greatest honor to serve you and the Society as your President, and I am looking

Eva M. Wojcik, MD, MIAC  Loyola University Medical Center Maywood, Illinois

Eva M. Wojcik, MD, MIAC

forward to working with and for you in the upcoming year. The customary objective of the President’s Message is to describe the future and what is ahead for the Society. Of course, I do not hold a crystal ball in my hands and cannot predict all potential unexpected events; however, I am certain that whatever happens, we will be successful in this coming year simply because we all hold our future in our hands.

As Abraham Lincoln once said: “The best way to predict the future is to create it,” and that is what we’ll do this year – we will create our future! We also have to keep in mind what Theodore Roosevelt did say: “The more you know about the past, the better prepared you are for the future.” Therefore, what we do know:

  • We have a strong Foundation – Cytology is relevant today more then ever. We are the best suited to provide a diagnosis on minimal amount of material that is obtained in a least traumatic way.
  • We have a proven record – When we say “We Save Lives One Cell at a Time,” we mean it. This is not an empty slogan – that is what we do, every single day!
  • Our Membership is strong, dependable and growing.
  • We have a solid structure – our Bylaws are effective and our National Office is composed of people who devote their careers and lives to this Society.
  • We are financially stable due to the prudent stewardship of previous ASC Presidents and the Executive Board.
  • We are flexible and we can adapt – our Strategic Plan is being reviewed constantly and adjusted as needed to address new, unpredicted changes in our health care environment.
  • We are very proud of and committed to the Society – after all, the ASC is OUR Society.

Success Starts with Opportunity

The ASC has been MY Society for a quarter of the century. Exactly 25 years ago, I attended my first ASC Annual Scientific Meeting in Washington, DC. That was one of the proudest moments in my life. Just a few years earlier, I arrived in this country not speaking any English and then at this national meeting, I am a senior pathology resident presenting two posters! From day one, the ASC gave me an opportunity and that continued through all those years. Considering that “success starts with opportunity,” when it was time to work on committee appointments, I have followed these guiding principles: opportunity for everyone, inclusion, transparency, rules, and accountability. From the beginning my goal was to include all members who have volunteered through the Call for Volunteers. In order to achieve this, in most cases no multiple appointments were made and Executive Board members were not appointed to serve on other committees this year; however, Board members will have advisory roles as liaisons between the Board and their assigned committees.

I am very happy to report that whoever volunteered, 100% became a member of a committee! We made 95 new appointments out of 246 committee members (38.6%). Each committee has defined responsibilities, initiatives and charges according to the updated Strategic Plan. In addition, I asked each committee to identify a specific, measurable goal to be completed by the end of one year. Each project has to follow the “3T” rules: what is the final measurable Target, what is the Timeline and what is the Team responsible for individual milestones? I plan to write a Presidential Blog to keep you informed on the progress of our committees’ work.

In addition, each member of a committee will be expected to provide at least one question for the Progressive Evaluation of Competency (PEC) question pool. Of course, those members who have any conflicts of interest would be exempt. Also, each member will serve as an ad hoc reviewer for our journal, Journal of the American Society of Cytopathology (JASC). Therefore, there will be plenty of opportunities for everyone to serve our Society.

Theme – What’s your value?

I am not sure if you know, but once you are the President-Elect, everyone will ask you: What will be the theme for your presidency? For many months, I have been thinking, what will be my theme, what will be my theme? Considering all the changes around us while we are entering into a value based health care, the logical question coming to our minds is – what is our value and, the most important one, how to measure it? Currently, we are living in the “world of dashboarding.” Everything is measured and tracked, therefore, how to dashboard our value? How to translate our values into numbers? Many may see this as a challenge, but for me, I see an opportunity, opportunity for research.

So, I challenge you – provide basis, evidence for our value. Think outside the box; think about downstream effects of your contributions. For example, how your timely diagnosis affected the length of stay (LOS) or patient satisfaction. Use any opportunity to present your data locally, show your colleagues how your work positively influences patients’ outcome. Most importantly, we have to publish these data. We have to remember, published evidence-based data is the basis for any new guidelines, regulations, reimbursement, codes, etc. Therefore, let’s gather in New Orleans at our next Annual Scientific Meeting and share all these data with each other. I will work with the Scientific Program Committee to ensure a venue to exchange our experiences.

But that is not enough……remember, our future is in our hands; therefore, we have to become visible and become advocates for our profession, for ourselves. It is time to learn how to be comfortable being uncomfortable. It is time to get out of our “basements,” from behind our familiar, comfortable microscopes and tell everyone who we are and what our value is. We have to meet patients, most importantly talk to them, tell them that based on our diagnosis they can be treated, they can be healed.

We also have to remember, we are part of the Pathology family and we share visions and goals of our sister societies, and we also face common challenges. The scope of practice changes will affect all of us regardless of specialty or the level of training. What keeps us apart from others is that indeed we are taking the future in our hands and working on defining and discovering new career pathways. We are putting our words into action and we see the first results of our inter-societies collaborations. The best example is the work of the ASC/ASCP Workgroup, “Focusing on Emerging Role of Cytotechnology” and their very successful launch of an Advanced Cytopathology Education (ACE). The next ACE will take place on May 21-22, 2016 at the Loyola University Medical Center in Maywood, Illinois, a western suburb of Chicago.

New Strategic Plan

We have been very proud to follow our robust and visionary plan initiated in 2012 by our previous President, Dr. Lydia Howell and recently extensively updated under the leadership of Dr. Ritu Nayar and Dr. Michael Henry. However, it is time to take a more critical look and, most importantly, evaluate our current Strategic Plan’s relevance in the context of incoming changes in the health care environment. This could not be more relevant today, particularly in the context of a recently released Institute of Medicine (IOM) report on “Improving Diagnosis in Health Care.” The report was released on the 15th anniversary of the first IOM report, “To Err is Human” that transformed the way we think about the patient safety. The current report concentrates on diagnostic errors, and it proposes aspirational goals of improving the diagnostic process and gives concrete recommendations for major systems and process changes. Our goal will be to keep those recommendations as guiding principles and align our new Strategic Plan accordingly. This work will be lead by Dr. Michael Cohen, Professor and Vice Chair at the University of Utah who was one of 21 members of the IOM committee that created that report. The progress of this work will be presented on this forum.

WATTBAC – What A Time To Be A Cytologist!

In summary, exciting times and projects are ahead of us. We are extremely well positioned with our natural and historical team approach to patient care and, most importantly, with our proactive approach to our future. This is the time of opportunities for our profession and our Society!

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Message from the ASC President

What an honor it is to have been elected to the presidency of the American Society of Michael Henry - ASC PresidentCytopathology. This organization has been central in my professional life for almost 30 years. Many of my friends and mentors have been Presidents of the ASC, and I feel extremely privileged to join their ranks. The ASC has grown and changed significantly since I first joined right out of residency. Over the years these changes have strengthened the organization and put it on a path, which should lead to continued success. As an example, it is interesting that my presidency came from changes made many years ago when we moved to a competitive election for officers, which allowed the members to select from at least two nominees rather than a single candidate. While I did not win the first time I was nominated, I became part of a growing group of well-qualified members with experience and expertise who could be tapped by the Nominating Committee for possible election. Overall, these electoral changes have resulted in a stronger electoral process and demonstrated the wisdom of the Officers and Members who made the changes.

Change and innovation are integral to the message I want to convey in this letter to the ASC membership. All of the messages written by the last several Presidents have talked about the changes that medicine is undergoing and how they may affect the field of cytology and the ASC. We live in an exciting and sometimes uncertain time of growth, new knowledge and innovative techniques, many of which will transform the way we practice medicine. Transformational forces come not only from the scientific side but also from the regulatory and business side of medicine. We are moving away from private practice – fee for service medicine – and no one is sure where this will lead. It is certain, however, that for the foreseeable future cytology will be a valuable part of diagnostic and therapeutic medicine.

The field of cytopathology is unique. In an age when most of pathology is subspecializing into smaller and smaller areas of expertise, cytology remains a generalist field. Cytologic specimens are derived from the entire gamut of tissue and disease. The range of specimens that we utilize is vast, derived from fine needle aspiration, fluids, brushes, washes, core biopsies or any other technique, which yields small tissue samples. To be a good cytopathologist requires knowledge that spans across all of the anatomic pathology specialties and even many of the clinical areas. This generalist background is one of the strengths of cytopathology, which will keep us relevant far into the future. But at the same time, we will need to work to keep this relevance and not let some of these collection techniques become the provenance of subspecialists.

Collaborative efforts between the ASC and other pathology and medical organizations will be necessary to move our agenda forward on a national basis. Under the leadership of our most recent Past Presidents we now have working arrangements or memorandums of understanding with many of the national pathology and other medical organizations. We will continue to make overtures with these and other organizations to collaborate in areas where it makes sense. We are the repository of vast experience in cytologic methods, diagnostic techniques and education. The ASC must be involved with any organization that is making decisions or recommendations where cytology is concerned.

In 2012, under the leadership of Dr. Lydia Powell the ASC Executive Board (EB) developed a new Strategic Plan, which was implemented along with an updated vision and mission statement. This Strategic Plan contained specific goals and benchmarks as well as strategies to accomplish them. Most recently, at the last Board Meeting the EB reviewed the plan to see how well we have accomplished these goals and to write new ones as appropriate. My next President’s Blog will detail the results of this review.

Finally, there are a couple issues that are foremost in my mind and that will need to be addressed in the near future. These are the future role of the cytotechnologist in the laboratory and the role of cytopathology in the field of molecular testing.

The Future Cytotechnologist

We know that primary GYN screening using Pap tests will continue to decrease. During the past year the long anticipated clearance for primary HPV testing with cytology as the reflex test was approved by the FDA. While this is concerning to many in the field, there has been no rush to start this testing on the part of primary care clinicians. As with most new techniques, this type of testing will slowly work its way into the field; and it is still unknown how quickly it will be accepted.

We have known this was coming for some time. The ASC and other organizations are already looking at how the field of cytotechnology will and should evolve as Pap screening becomes a smaller portion of the work cytotechnologists perform. At this year’s Annual Scientific Meeting, the CPRC presented the results of meetings to develop a professional scope of practice for a proposed mid-level pathology practitioner for the field of cytopathology. Over the next year we will work with the CPRC, ASCP, CAP, and ASCT on this concept, especially directed to determining the need for this type of practitioner through a detailed practice analysis. In the meantime, we will also look at how to help current cytotechnologists transition to new technologies from their primary screening roles.

While we still do not have a clear idea of the cytology workforce over the next several years there are worries that the cytotechnologists are aging and that given the small overall numbers in the profession a workforce deficiency is certainly a possibility. There is already a definite shortage of laboratory professionals in areas such as histotechnology and molecular biology and with the steadily decreasing number of cytotechnology schools, now down to only 25 active programs, cytotechnology may also be facing a similar shortage. The recent partnership with the ASCP, ASCT and CAP to provide membership to the CPRC as well as the development of the Cytology Education Learning Lab (CELL) will help to develop the new curriculums that will be needed to provide the innovative education for our cytotechnology students.

I would like to finish this section by talking about the role the Mayo Clinic has taken in redefining the practice of cytotechnology. Over the past 15 years, we have pioneered the use of cytotechnologists to perform many somewhat non-traditional tasks. We have leveraged the cytotechnologist morphology training to utilize them in the screening of FISH cases on cytologic preparations, digital analysis of breast prognostic markers on tissue, analysis of circulating tumor cells and most recently initial review of tissue for molecular studies. This is in addition to the more traditional roles of on-site evaluation of FNA specimens and screening of non-GYN cytology. We have moved away from GYN screening as the primary CT role as our numbers of GYN Pap tests have decreased. Currently, Pap screening involves less than 10% of our technologist workload but we have actually increased the number of cytotechnologists needed to support the laboratory’s needs. We have found that all of this has made economic sense for our laboratory as it has freed up the pathologists to do their job more efficiently. Will this work in other settings? I don’t know the answer to that, but I do believe that as the business of pathology changes, this type of innovative use of qualified cytotechnologists will become more common.

Cytology and Molecular Pathology

We are currently entering a new era of medicine based on molecular techniques used for diagnosis, therapy and the monitoring of treatment response and disease progression. As I mentioned above, the field of cytopathology is unique in the breadth of specimens that we handle and utilize. Many of these specimens can and are being used for molecular testing of many types. This past year the ASC worked closely with the Papanicolaou Society of Cytopathology (PSC) to develop a joint position statement on the use of molecular testing on cytologic specimens. This position statement was approved by the ASC Executive Board at the Annual Scientific Meeting in Dallas. Over the next year the two organizations are also writing a white paper on molecular testing on cytologic specimens that will flesh out the details on many of these techniques and how they can be applied to our practice.

It is obvious that multidisciplinary collaboration will be needed in the effective utilization of these molecular techniques in cytologic specimens. Many molecular tests need to be performed in specialized laboratories and the cytopathologist will be the intermediary between the clinician collecting the sample and the performing laboratory. In those instances cytopathologists and cytotechnologists are well placed to work with clinicians to determine the on-site adequacy of specimens and determine the appropriate triage for the most effective use of small samples. Other molecular tests such as FISH analysis can be performed directly on cytologic preparations such as is currently done for urinary tract cytology and biliary or esophageal brushings. In my opinion, these samples are best interpreted by cytotechnologists trained in FISH techniques. Their morphologic experience in interpreting cytologic preparations makes them the obvious choice to select the appropriate cells for FISH analysis on smears or liquid based preparations.

There are more challenges because of the broad gamut of our tissue samples. We not only have tissue fixed in formalin and paraffin embedded (FFPE) but have samples that are fixed in alcohol and smeared or prepped as thin layer samples. As noted in the position statement: “Given the versatility of cytopreparatory techniques, the development and careful validation of molecular assays for these platforms is important.” The next several years will be a time of growth and greater understanding of which molecular techniques have clinical importance and how we as cytopathologists and cytotechnologists will fit into this burgeoning field. It will be vitally important that the ASC takes a primary role making sure our members are ready to move into the molecular era.

In summary, these are fast changing and exciting times full of challenges to our membership. I will be working with the Officers, Executive Board and the Committees to ensure that the ASC will continue to move in a positive direction to meet these challenges. My challenge to the ASC Members, Officers and Committees is to take the ASC vision to heart and look for innovative ways to grow/move the ASC forward in these turbulent times. Let me know about your ideas. While the Officers, Executive Board and Committee leaders have a wealth of knowledge and expertise, we don’t have all of the answers or specific ideas for projects, educational tools or new ways of doing things. Your contributions can be large or small; it doesn’t matter as long as you are an active participant in the organization. Volunteer – we are always looking for new members to add to the committees or other activities but we can’t use you unless we know who you are. Forms for volunteers are located on the ASC Web site. You are never too young or inexperienced so don’t be shy. We all started somewhere and who knows, someday you may be writing this message yourself.

Michael R. Henry, MD

HPV Primary Screening: Considerations for ASC Members

Ritu 2013

Ritu Nayar, MD ASC President

The ASC leadership and its membership are committed to supporting women’s  health and working collaboratively with other pathology and clinical professionals to effectively prevent cervical cancer in the United States.

Primary screening with HPV is now one of three currently available test options for cervical cancer screening. We can best serve our patients by:

a)    Understanding the value, as well as the limitations of various testing options available for cervical cancer screening.
b)    Offering clinically validated testing with adequate quality control in our laboratories.
c)    Keep abreast of the current published scientific data so that we are able to effectively communicate with our clinical colleagues and other professional organizations.

With the FDA approval of the first HPV test for primary cervical cancer screening on April 25th 2014, clinicians in the United States will now have 3 different first line screening options that they may offer to patients: the Pap test, co-testing with Pap and HPV tests, and HPV testing as a stand-alone test. Specifically, the Roche Cobas® HPV Test was approved for primary screening for cervical cancer as a stand-alone test. To date, none of the other FDA-approved HPV tests (Qiagen’s Digene Hybrid capture® 2, Hologic’s Cervista® HPV and Hologic-Genprobe’s APTIMA® HPV Assay) have been approved for this indication. Note that there is no role for low-risk HPV testing in cervical cancer screening and management.

As cytopathologists and cytotechnologists what should we be aware of with respect to discussing this testing option with our clinical colleagues and among ourselves when considering offering this test in our laboratory? Some key considerations are included below.

Which Test has been recently approved for primary cervical cancer screening by the US FDA?

The first, and currently only FDA approved test for Primary HPV screening for cervical cancer in women 25 and older in the United States is the cobas® HPV Test, which is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, California.

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus (HPV) in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting an additional 12 high- risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

The cobas® HPV Test was first approved by the FDA in 2011 for use in conjunction with or as a follow-up to a Pap test. The additional approval expands the use of the test as a first-line primary cervical cancer screening test.

Cervical specimens that may be tested with the cobas® HPV Test include the following liquid based collection media and collection device:
• ThinPrep® Pap TestTM PreservCyt® Solution
• Endocervical Brush/Spatula

Details of the test and approval can be found in the cobas® HPV Test package insert and at www.hpv16and18.com. (Ref 1).

What was FDA’s basis for approving the Roche HPV test for primary screening?

The FDA requested the appointed advisory committee to assess whether the cobas® HPV Test is safe and effective for the proposed new intended use as a primary screening test for cervical cancer.
Data supporting the use of the cobas® HPV Test as a primary screening test for cervical cancer included the U.S. based, multicenter, prospective ATHENA study of approximately 40,000 women, ages 25 years and older undergoing routine cervical cancer screening. Women who had a positive Pap test or who screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical biopsy. All biopsy results were compared to the Pap and cobas® HPV test results. Data from this study, which included three years of follow-up on women who went to colposcopy, suggested that the cobas® HPV Test is safe and effective for this expanded indication for use as a primary screening test (Ref 2-4).

Details of the FDA advisory meeting, including a complete transcript of the proceedings and supporting data are available on the FDA website (Ref 5-6). Additional data from Roche’s ATHENA trial, as well as data pertaining to comparison of HPV only testing at 3 years to Pap/HPV co-testing at 5 year intervals is due to be published later this year.

What should laboratorians be aware of when considering if they should offer HPV primary screening?

Since cervical cancer screening using HPV alone is a new option, with limited long term follow up data, it is important for laboratories who offer HPV primary screening to use methodology that has been FDA-approved for this specific indication and verified in the testing laboratory.  Laboratories should be enrolled in adequate proficiency testing and perform regular quality control and statistical analysis of HPV tests that are used for screening (co-testing/ primary screening) and triage.
Laboratorians should communicate with their clinical colleagues to clarify the various testing modalities that the laboratory is able to offer for cervical cancer screening and provide adequate and clear test options in order to enable appropriate test utilization.

Did the ASC and CETC give any input to the FDA before its approval of the Roche HPV test for Primary Screening?

The Cytopathology Education and Technology Consortium (CETC) member organizations include the American Society of Cytopathology (ASC), the American Society for Clinical Pathology (ASCP), the American Society for Cytotechnology (ASCT), the College of American Pathologists (CAP), the International Academy of Cytology (IAC) and the Papanicolaou Society of Cytopathology (PSC).

The CETC submitted a written statement to the FDA advisory panel for its March 12, 2014 hearing on the Roche PMA, and a summary of the CETC concerns was presented to the panel by CAP CETC liaison and ASC Executive Board member, Dr. Patricia Wasserman.

The CETC stated that
The Pap test and the dedication of professionals like cytotechnologists and pathologists have significantly benefited women’s health by reducing the incidence of, and mortality from, cervical cancer. However, cervical cancer screening in the United States remains opportunistic, with far from uniform test accessibility and patient compliance. It is not an organized national program with patient reminders as in the United Kingdom and other European countries that are considering adoption of primary HPV screening. To avoid an increase in cervical cancer, regular screening is required, with methodologies that provide an optimal balance between sensitivity and specificity and remain readily accessible and affordable for all women.”

The CETC asked the FDA advisory panel to consider the following concerns that may potentially impact safety and efficacy for cervical cancer screening in the United States, if HPV primary screening is approved by the FDA:
(1)Test internal control.
In the Roche package insert for the cobas® HPV test, information regarding specimen adequacy, the internal control for epithelial cellular components and potential interfering substances is limited. The Roche HPV test uses a beta-globin gene internal control as a measure of specimen adequacy; this is not specific for cervical epithelial cells. For example, Roche did not show that beta-globin from inflammatory cells could not cause a false assessment of a specimen as adequate if it contained only inflammatory cells and no epithelial cells. In the ATHENA trial, several morphologically unsatisfactory cytology samples did appear to have valid HPV testing results; however, more problems may arise when this testing is used outside of clinical trials.
(2) HPV Negative Cervical Cancer
As with any laboratory test, the sensitivity of HPV testing is not 100%. A subset of carcinomas, both squamous and glandular, and other tumor types may not be detected by HPV testing. A recent United States cancer registry study found that 9.4% of cervical cancers were HPV negative and an additional 3.2% contained rare HPV subtypes (Ref 7).
(3) HPV Testing Methodology
As laboratorians, CETC cautioned that primary screening should be performed using HPV tests that are FDA-approved for the specific indication of primary cervical cancer screening. The testing laboratory should be CLIA-approved and participate in regular proficiency testing and perform verification and continually monitor quality assurance.
(4) Follow up of Primary HPV screen results
Before primary HPV screening for cervical cancer is adopted in clinical practice, there should be clear evidence-based guidelines for the follow-up of positive and negative tests to prevent loss of women to appropriate follow up and potential increases in cervical cancer incidence.  The prevalence of HR-HPV types varies with demographic populations and the current US population is very diverse, in contrast to the patient populations in the prior European trials. Due to the documentation of HPV-negative squamous cell carcinoma and adenocarcinoma, women should have a morphological examination (Pap test) in their screening history and should not be screened solely with HPV tests. Screening younger women with HPV tests may increase overall patient harm from overtreatment of positive results that detect low grade squamous lesions and women under 30 may be better served using a less expensive, more specific test – the Pap test.

When will clinical management guidelines for HPV Primary Screening be available?

The Roche PMA sought the expanded indication for using HPV as a first-line screening test for the cobas® HPV Test – Roche specifically proposed that women who are 25 years and above can be tested first with the cobas® HPV Test in order to triage them into the appropriate risk groups as follows:
a)    Women who test negative for high-risk HPV tests by the cobas® HPV Test should be followed up in accordance with physician’s assessment of screening and medical history, other risk factors, and professional guidelines.
b)    Women who test positive for HPV genotype 16 and/or 18 by the cobas® HPV Test should be referred to colposcopy.
c)    Women who test high-risk HPV positive for any of the 12 other high-risk HPV types, but are 16 and 18 negative, should be followed up with cytology to assess the need for colposcopy.

The FDA approval of primary HPV screening does not change current medical practice guidelines for cervical cancer screening. Primary screening with HPV alone is currently not included in the consensus guidelines for cervical cancer screening in the U.S. and it will be up to our professional societies to discuss inclusion of such a screening option in future medical practice guidelines. Cervical cancer screening guidelines allow professional societies to distinguish preferred screening algorithms from acceptable screening algorithms. They are also able to provide detailed recommendations for how to follow-up on specific cytology results and/or specific combinations of cytology and HPV test results over time, even for women who do not have immediate colposcopy. A woman who is not sent immediately to colposcopy may be followed up in different ways depending upon her test results, history and clinical findings.

A task force appointed by the Society of Gynecologic Oncology (SGO) and the American Society of Colposcopy and Cervical Pathology (ASCCP) is preparing an interim clinical guidance document for HPV primary screening in the United States. This is expected to be published in the next few months. Drs Diane Davey, Robert Goulart and Ann Moriarty were the joint ASC-ASCP-CAP representatives to this task force. At this time it is not known when other professional societies, including the ACS and USPSTF, will issue updated guidelines for cervical cancer screening.

We know from experience with prior guidelines that it takes substantial time and effort to develop evidence-based algorithms and provide education for providers and patients. In spite of concerted efforts to disseminate the 2012 ASCCP Consensus Guidelines for the management of abnormal cervical cancer screening tests and cancer precursors, there is still significant variation with compliance. Currently, cytology only testing, as well as, co-testing are being used variably in different age groups for cervical cancer screening. It is estimated that co-testing is being utilized in less than 50% of patients in the United States. Thus as with any new testing strategy, the adoption of primary HPV testing will most certainly require time and ongoing monitoring of clinician acceptance, patient compliance, as well as, cost-benefit and outcomes analysis.

As we consider the current and future scientific data and literature, our overriding goal should remain the same – to provide the highest level of quality care to the patients we serve. However, we must remember and reiterate that no screening test is perfect. We cannot eliminate all risk with screening, no matter what is the test or target. The very basis of screening requires that it be done periodically and repeatedly be it a Pap test, mammogram or primary HPV screening.

The choice of cervical screening method may vary for a variety of reasons. Patient and provider preference, geographic, demographic, and socio-economic considerations may all affect the choice of screening modality in a specific country, region, or practice setting. As is well proven, any screening is better than no screening, and we must keep availability and cost to our patients for all of these screening options in the forefront of our discussions.

Selected References

  1. Cobas® HPV Test [package insert, US]. Branchburg, NJ: Roche Molecular Systems, Inc; 2011
  2. Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011; 135(3):468-475.
  3. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens CM, Wright TL. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011; 136: 578-586.
  4. Castle PE, Stoler MH, Wright TC Jr., Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a sub analysis of the ATHENA study. Lancet Oncol. 2011; 12(9):880–890.
  5. US FDA Primary HPV Screening Approval- Press Release
  6. US FDA Advisory Meeting materials
  7. Hopenhayn C, Christian A, Christian WJ, et al. Prevalence of Human Papillomavirus Types in Invasive Cervical Cancers From 7 US Cancer Registries Before Vaccine Introduction. Journal of Lower Genital Tract Disease 2014; 18(3). DOI:10.1097/LGT.0b013e3182a577c7

 

 

“It is a Great Honor to Accept the Presidency of this World Class Organization”

Dr. Andrew A. Renshaw, MD

Dr. Andrew A. Renshaw, MD

I am a very lucky President.  I am surrounded by excellent mentors, prior Presidents, future Presidents, and co-workers.  This organization has withstood the test of time, and has greatly benefited from the many excellent people who have volunteered their time and efforts to make this the organization that it is.  This organization has an effective set of bylaws, a stable National Office Staff and executive Vice President, and a stable membership.  Cytology continues to be a field that benefits the patients it serves every single day, one cell at a time, and the ASC continues to benefit its members.

In many ways, the goals of the ASC for my presidency have already been set by the actions of the leadership that has come before me.  No President can do it alone, and very few initiatives can be successfully achieved in a single year.  Nevertheless, during this year I would like to focus on three areas where other leaders have already paved the way:

  1. Improve the quality of cytology through      evidence based practice;
  2. Make the ASC part of a big tent of      pathology and cytology organizations;
  3. Help cytotechnologists adapt and evolve.

The ASC already has had several initiatives to improve the quality of the practice of cytology.  However, the effectiveness of these efforts has been uneven.  There are many reasons for this.  Importantly, quality means different things to different people, and in fact, it has proved surprisingly difficult to measure quality in pathology in general and in cytology specifically.  In addition, measuring quality, as opposed to sexy molecular studies, is a very hard way to pursue an academic career.  There is simply more money to pursue new tests that look at the molecular structure of cancer than to measure something as hum drum as workload.

Nevertheless, without quality, cytology cannot survive; other tests will simply replace it.  The writing is already on the wall.  While HPV testing is a great advance and, I believe, should be used more than it currently is, interpreting the studies that compare HPV to cytology is difficult because the quality of the cytology arm is not clear.  If the sensitivity for CIN2 on biopsy of cytology is truly less than 40%, which is what at least one center achieved in large randomized trials, then we should immediately switch to HPV testing instead.  Fortunately, I do not believe this to be true – but only studies that address the issue of quality can answer this question.  Urovysion is another excellent test, one that I also love to use, but similar questions about the quality of the cytology arm of studies of Urovysion have also been raised.  At the end of the day and for better or worse, if we do not actively seek to define standards for quality in cytology, cytology will be replaced by these molecular tests for no other reason that the quality of these tests can be more clearly defined and controlled.

But quality will not ensure the future of cytology alone.  The world of medicine is becoming increasingly competitive and the field of cytology is at risk of being lost in the sea of other specialties, which are also actively seeking to expand their own influence.  In such a setting, it is imperative for the ASC to work with other organizations to pool our resources and influence for the benefit of all.  Certainly the ASC should continue to preserve its independence and its own unique approach to supporting the interests of its members.  Nevertheless, this does not mean that every other organization that does cytology is a competitor.  More and more the ASC will need to seek alliances to successfully navigate the issues that will arise in the future.  If done right, these alliances can be a win-win proposition for all the organizations involved.

And one group that really deserves a win is our cytotechnology membership.  Previous Presidents and many members at all levels of this organization have already pointed out that the future of cytotechnology is evolving.  This trend cannot be stopped.  What can be changed is where it ends up. In one scenario, cytotechnology may be a field that no longer exists.  In another, cytotechnologists may end up as competitors to pathologists.  Neither of these scenarios is a win-win, but neither of these scenarios is written in stone.  It is in all of our best interests to actively work to make sure that cytotechnologists remain an indispensable part of the cytology team that works to provide the best quality of care to our patients.

Finally, as all of you know, there is great uncertainty about the financial future of medicine in general.  Regardless of which way things go, it seems very unlikely that there will be more money available to work with in the future than we have now.  Certainly funds for education are likely to decrease, and since the ASC is primarily an educational organization, this is a very important challenge.  As a field, we must be creative in figuring out how to support our future efforts, and also we must be creative in figuring out more cost effective ways to carry out those efforts.

Fortunately, the ASC has a nest egg of investments and a strong Foundation.  Working together, we have the time and the resources to come out of this difficult period stronger and better placed than we entered it.  However, this will be a difficult process.  No amount of creativity will allow the ASC to continue to be all things to all people all the time.  Some difficult decisions and priorities will likely have to be made.  I would hope that when those decisions are made, people will focus on objectives that benefit everyone associated with the ASC – patients, members, and cytology as a whole, and that they recognize they do not have to make these decisions alone, and that the important resource that is our cytotechnology membership will be given the support and resources they have certainly earned.

MUG: 

Andrew A. Renshaw, MD