March 14, 2014
First, I would like to summarize the advisory meeting proceedings and the ASC’s participation:
On the morning of 3/12/14 you were provided the link to the FDA advisory meeting materials. Note that Roche is seeking approval for HPV as an alternate primary screening method. The role of the FDA is to determine safety and efficacy of the “candidate” relative to the “comparator”. In this case the comparator is cytology alone, not co-testing. Later that evening we informed the membership that the advisory panel unanimously (13:0) approved that the Cobas DNA test is safe and effective and that the benefits outweigh the risks for this indication. The FDA will take the panels feedback under advisement and in the near future will issue the final FDA decision. Yes -it is more than likely that FDA will approve the Primary Screening claim requested by Roche.
The submission data from Roche was substantial and I encourage you to look at it if you have not done so.
The advisory panel was made aware that in addition to the Athena trial data submitted and presented by Roche, there is new data from Kaiser that shows that CIN3/cancer risk following a negative HPV test is smaller than after a negative Pap and almost as small as after a negative co-test suggesting the relative safety of primary HPV alone at an appropriate interval, conservatively 3 years. Publications from these sources are in preparation and/or press and will be available in the near future.
A number of questions were asked, and topics discussed during the advisory committee meeting. These included the potential impact of HPV vaccination on the proposed follow up algorithms; screening and follow up in the 25-29 years age group; Roche’s choice of CIN2/3 versus cancer as an end point, histology interobserver variability and adjudication with p16 in the HPV negative subset, and HPV negative cervical cancers. No doubt that for some of these questions there are no clear cut answers yet, however they have been noted by the advisory panel.
Clinicians in the United States will now have 3 different screening options that have different intervals, and different triage algorithms. We know from prior guidelines that it takes substantial time and effort to put together evidence-based algorithms and provide education for providers and patients. In spite of concerted efforts to disseminate the 2012 consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors, there is still significant variation with compliance and currently cytology only as well as co-testing are being used variably in different age groups. Thus any new testing strategy will likely require on- going analysis including monitoring compliance, cost- benefit analysis, etc.
I would like to emphasize that the ASC was involved in the comment period for this FDA advisory meeting as well as in planning for future clinical guidance for HPV testing as a screening mechanism for cervical cancer in the United States.
1) Collaborating with our other professional organizations – ASCP, CAP, ASCT and PSC, and under the umbrella of the Cytopathology Education and Technology Consortium (CETC), the ASC submitted written concerns to the FDA panel. The CETC statement, which was read during the FDA meeting public comment period by Dr. Patricia Wasserman (ASC-EB member and CAP-CETC representative), specifically raised the laboratory-related issues of the beta globin control not being specific for epithelial cells (hence the possibility of inadequate specimens being called negative) and those related to the potential (mis)use of Laboratory Developed Tests (LDT), in this case, HPV tests, that are not clinically validated for primary screening. We also addressed the data/references on HPV negative cancers.
The CETC statement emphasized 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 cases, regular screening is required, with methodologies that provide an optimal balance between sensitivity and specificity and remain readily accessible and affordable for all women”
2) The ASC, ASCP and CAP appointed 3 joint representatives-Dr. Diane Davey (ASC Past President, CAP Cytopathology Committee Past Chair and ASC CETC representative), Dr. Robert Goulart (ASCP CETC representative) and Dr. Ann Moriarty (ASC Past President, CAP Cytopathology Committee- Past Chair) who provided the laboratory perspective on a task force appointed by the Society of Gynecologic Oncology (SGO) and ASCCP to prepare a document for clinical guidance on HPV primary screening in the United States. Our representatives have been active in this group since December of 2013. The publication from this group will provide interim guidelines for usage of primary HPV screening and acknowledge the areas of caution, including the laboratory related issues raised by our representatives.
Secondly let’s not forget the other sustained efforts of the ASC leadership and volunteers – which includes so many of you – in proactively moving towards future training and practice models for cytotechnologists and more recently, pathologists.
1) History of ASC Efforts
The history of ASC’s strategic discussions regarding workforce and preparedness for change in practice, especially for cytotechnologists, began in November 2001, followed by consultation with The Forbes Group in 2006. This effort resulted in a report entitled “Plotting the Future of Cytotechnology: An Environmental Analysis of the Driving Forces of Cytology”, which outlines changes in market forces and the relationships between pathologists, clinicians, and other specialists that might lead to the emergence of new professions (or professional roles) in the future. It was recommended that the ASC hold an Alternative Futures Summit to engage potential stakeholders in dialogue encompassing different outcomes identified in the report. A summit was held in November 2009 that produced a white paper titled “Facing the Future of Cytopathology,” which focused on discerning the future needs of our profession. This document remains a valuable resource for future directions for the Cytotechnology professional.
With the challenge of decreasing cervical cytology volumes, many hospital based cytopathology laboratories have seen an increase in non-gynecologic volumes; procedure attendance and some have incorporated molecular testing in cytopathology laboratories. Innovative models, such as that at the Mayo Clinic in Rochester, Minnesota, have already proven the value that cytotechnologists can add in a variety of non-traditional roles in laboratory medicine. At the 2011 Annual ASC meeting in Baltimore, the Current Issues in Cytology session entitled “Transformation in Education and Practice for Cytotechnologists” was presented to discuss the impending changes and showcase the activities of laboratories that have been on the leading edge of adapting to the new environment.
2) Cytotechnology Program Review Committee (CPRC)
Until 2011, when we welcomed ASCP, CAP and ASCT as co-sponsors, the ASC was the sole sponsor of the Cytotechnology Program Review Committee (CPRC). Over the past decade, the CPRC has actively championed an evolution of the traditional cytotechnologist role in order to meet the challenges of changing practice patterns for these professionals. In 2011, the multi-organization sponsored CPRC, led by ASC, formally embarked on implementing a change in the scope of practice for cytotechnologists.
In 2012, the CPRC was sponsored to conduct a 2-day retreat in order to begin implementing Phase 1 of the change in scope of practice for cytotechnologists. This concentrated on curriculum review and revisions for entry level competencies. As a result of the CPRC recommendations, in November 2013, the Commission on Accreditation of Allied Health Education Programs (CAAHEP) approved “The Standards and Guidelines for the Accreditation of Educational Programs in Cytotechnology,” which detailed new entry-level competencies (ELC) for cytotechnologists that go into effect July 2014. The new ELC’s place the curriculum on a modern footing designed to integrate the emerging areas of molecular medicine and digital technology and to provide the basic tools necessary to expand the cytotechnologist’s role in diagnostic pathology.
In 2013, in response to the need to assist programs in locating appropriate resources to teach these new competencies, the CPRC and their sponsors (ASC, ASCP, ASCT, and CAP) participated in the creation of a committee to collect, edit, vet, and write various educational resources for use by Cytotechnology Programs. The members of this Cytology Education Learning Lab (CELL) Committee have already developed this resource. The “CELL” Website will be live shortly!
In February 2014, the CPRC was funded by the sponsors to hold a second two‐day, face‐to‐face meeting to move into Phase 2 of the implementation of changing scope of practice for cytotechnologists and develop recommendations for a new “mid-level pathology practitioner”. The group had a very successful retreat and the sponsors will be getting the recommendations from this group later this month.
3) Workforce shortage
The workforce shortage for laboratory professionals hit us a while ago. However, workforce shortages have been predicted more recently for pathologists, due to possible GME funding cuts and an aging workforce that will soon retire in large numbers. It is the opportune time to transition the current cytotechnologist roles, taking advantage of the strong morphology training plus the newly added skills of these highly trained individuals and develop a midlevel pathology practitioner to support needs of pathologists, patients and the health care system.
Multiple societies have recognized the need for pathologists and laboratorians to work together to address these workforce issues – ASC has actively joined these endeavors at the outset of collaborative discussions. In the past 4 months, the ASC became a member of the multi-society Pathology Roundtable, attended the multi-organization workforce summit and other leadership forums. We will be pursuing a number of initiatives to support our profession and practitioners through these team efforts.
So in summary – the ASC has been preparing judiciously and consistently to meet the challenges related to changing practice patterns that have been predicted for over a decade. This is the time for us to come together, brave the change, and continue to adapt to new roles. There is a lot that cytopathology, cytopathologists and cytotechnologists can contribute in the rapidly evolving health care arena- we need to seize these opportunities. Your leadership is very cognizant of our responsibility to support the needs of our current and future members. Our overriding goal remains the same- to be able to provide the highest level of quality care to the patients we serve.
Remember the ASC vision is “Saving Lives One Cell at a Time through Innovation, Teamwork, Education and Advocacy.”
With best wishes,
Ritu Nayar, MD, MIAC
President, American Society of Cytopathology.