Human papillomavirus testing is becoming an integral component of cervical cancer screening. Market forces will require most laboratories that perform Papanicolaou tests to develop a system for handling human papillomavirus testing also. Data and information are presented that may facilitate laboratories when addressing the following issues in the process of developing a human papillomavirus testing service: Which methodology is the best fit for the laboratory? Is it better to develop an in-house testing service or to send it out? How do I get started? What are the financial and economic issues, and how should they be managed?

Multiple factors should be considered in the selection of the human papillomavirus (HPV) technology for your laboratory. Some of the critical issues to be considered in this selection process are as follows: (1) What is the medical utility of this assay? Will this assay accomplish the needed functions for HPV testing in current cervical cancer screening protocols? What data support your selection? (2) What is the best way to integrate this assay into your cervical cancer screening service? (3) Does it make sense to run this assay in your laboratory? (4) Does this assay have the capacity to evolve with the evolving role of HPV testing?

The 3 primary HPV testing methods that are available are the Digene Hybrid Capture 2 (HC2) assay (Digene Corporation, Gaithersburg, Md), the Ventana Inform HPV (Ventana Medical Systems, Inc, Tucson, Ariz), and polymerase chain reaction (PCR) assays. Each of these assays uses a different method for detection of HPV. Evaluation of financial issues, testing volumes, workflow, technical expertise, and service issues will help determine which of the available tests are best performed in your laboratory and which are best downloaded to a reference laboratory.

Digene HC2 is the current industry standard. It is approved by the Food and Drug Administration (FDA) for testing on cervical samples. The Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS)1 and other major publications2,3 support its use in triage protocols for abnormal Papanicolaou tests. The American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines4 are based on data obtained using the Digene HC2 assay. This assay is best suited for medium-sized to large laboratories with substantial liquid-based Papanicolaou test (LBPT) volume.

The HC2 assay measures the presence of RNA : DNA hybrids that are formed by RNA probe and target viral DNA. Separate RNA probe kits test for 13 types of oncogenic HPV (high-risk panel) and 5 viral types of nononcogenic HPV (low-risk panel). The HC2 assay involves 5 processes: (1) extraction and denaturation of DNA, (2) hybridization of RNA probe with target viral DNA, (3) capture of RNA : DNA hybrids onto a solid phase, (4) tagging of the hybrids with alkaline phosphatase–labeled antibodies specific for RNA : DNA hybrids, and (5) measurement of the amplified chemiluminescent signal.5 The strength of the chemiluminescent signal is measured in relative light units (RLU). A positive result has a signal strength greater than the average signal strength of the positive calibrators (ie, RLU/co > 1 is positive, where co = average calibrator value). A positive result indicates the presence of at least 1 of the types of HPV in the panel, but does not specify which of the types are present.

Laboratory workflow data from AmeriPath-Utah (Sandy, Utah) indicate that tracking, retrieving, accessioning, and preparing stored Papanicolaou specimens requires about 2 to 4 minutes each (3 hours for a full run) and can be done the day before testing. Running the assay requires a full 8-hour shift, of which about 20% can be used on other projects. Posttest interpretation, reporting, and data review for quality assurance purposes takes about 3 hours. Interfacing the equipment with the laboratory information system will reduce labor requirements. A medical technologist or equivalent staff person is required to run the test.

Cost analysis of this assay is complex because of a high number of variables. Kit items cost $30 per assay for high-risk probes and $10 per assay for low-risk probes. In the author's laboratory, a full run requires 8 hours of a medical technologist's time and 6 hours of a laboratory assistant's time. Partial runs require slightly less technologist labor and substantially less assistant labor. The HC2 assay has the capacity to run up to 96 calibrators, controls, or samples at once. The assay requires 6 calibrators per run per panel (12 for both panels), which allows up to 90 specimens per run for a single panel or 84 for both panels. The kit cost includes 6 calibrators. Therefore, full runs of 90 specimens will not have calibrator costs. If these initial 6 calibrators are used in partial runs, the subsequent runs from that kit will bear an additional cost for calibrators, which have the same disposable cost as patient samples when used this way. Other disposable items are required, and some must be purchased from other vendors at additional cost. The basic instrumentation costs $35 000 and is purchased or leased from Digene. Substantial additional laboratory testing equipment is required and must be purchased through other vendors if not available in the laboratory. The robotic equipment upgrade costs $199 000. Robotic equipment will increase productivity and reproducibility, while reducing labor costs. All prices are list prices current as of November 18, 2002 (J. Butler, Digene, oral and written communication, November 8, 2002). Lists of required equipment and disposable items are available through Digene.

Reimbursements will vary by region and mix of insurance. The reimbursement in our laboratory ranges from $22 to $111 and averages less than $40. Current Procedural Terminology (CPT) code 87621 is used once for each panel. Reimbursement data supplied by Digene based on survey data taken in 2000 indicate the reimbursement varies by region, and the national average is about $42 (Figure 1).

A break-even analysis requires evaluation of costs (see Table 1), reimbursements, and test volumes. This type of analysis provides greatest utility to individual laboratories when the assumed values of the variables are replaced with accurate laboratory-specific data. Common mistakes that overestimate profitability of a test include ignoring or underestimating indirect costs and laboratory overhead, failure to obtain reimbursement data from the laboratory's major providers, failure to factor for bad debt, and overestimating demand for test utilization. A typical laboratory will lose more than $10 per assay. See Table 2 for assumptions. To break even, the laboratory must reduce costs, receive discounted pricing, or increase reimbursements. A laboratory would break even if it runs 1 full panel per week, chooses not to repeat borderline results, and receives a 19% discount on equipment and all kit and disposable items. With this level of discount and no repeat testing of borderline results, 60 specimens per run would generate a loss of $1.50 per assay, and 30 specimens per run would generate a loss of $6.25 per assay. To generate 30, 60, or 90 specimens per week would require an LBPT volume of approximately 1200, 2400, or 3600 per week, respectively. See Table 3 for volume calculation assumptions.

The primary advantage of this assay is the abundant data that are available to support the use of this technology. In addition, it is FDA approved for use on the Digene Cervical Sampler and ThinPrep Pap test. Assays performed on SurePath (AutoCyte, TriPath Imaging, Burlington, NC) Pap specimens are equivalent to those performed on ThinPrep Pap Tests (Cytyc Corporation, Boxborough, Mass).6,7 Oncogenic and nononcogenic panels can be tested separately.

Disadvantages to using this assay are that it is time-consuming, labor-intensive, and has many steps that require precise laboratory skills. Profit margins are slim or negative. Breakeven requires a combination of an efficient laboratory, optimal reimbursements, significant test volume, and substantial discounts on equipment and supplies. Approximately 6% of assays are borderline (defined in our laboratory as an RLU/co between 0.8 and 3.0). Many borderline positive results become negative with repeat testing. Repeat testing delays results and triples disposable costs for that test. Cross-reactivity occurs between oncogenic and nononcogenic panels, resulting in false-positive results for both oncogenic and nononcogenic HPV types. With relatively hypocellular LBPTs or cervical samplers, there are no good internal specimen controls to assure that the specimen has adequate cellularity. Testing for low-risk types of HPV is profitable in most laboratories, providing an incentive to test for both panels in an attempt to avoid losing money on HPV testing.

Ventana Inform HPV is an analyte specific reagent (ASR) assay performed on both tissue specimens and LBPTs. Recent studies show promising sensitivity and specificity,8,9 but few published data are currently available.

Ventana Inform HPV is a chromogenic in situ hybridization test. A histology slide or LBPT slide is incubated with a fluorescein-tagged DNA probe and counterstained. Microscopic observation of specifically stained target cells indicates HPV is present. Staining is performed on an automated instrument, the Ventana BenchMark. Separate probe kits test for oncogenic HPV types (high-risk panel) and nononcogenic HPV types (low-risk panel). The kits contain the same viral types as the Digene kits. The threshold for detection of HPV appears to be between 10 and 50 viral copies per cell when using formalin-fixed tissue samples.10,11 

Distinct patterns of specific staining occur for episomal (cytoplasmic) replication and viral integration. The more common episomal pattern appears as a dense, opaque, blue oval that overlies the majority of the central portion of the target cell (Figure 2). The pattern of viral integration appears as multiple, opaque, small, blue, round foci of staining within the nucleus of the target cell (Figure 3). Generally, nuclear morphology is visible with the integrated pattern, but not in the episomal pattern. Specific staining of target cells indicates the presence of at least 1 of the types of HPV in the panel, but does not specify which of the types are present. Artefact and nonspecific staining must be distinguished from specific staining of target cells.

Laboratory workflow begins with preparation of a tissue or cytology slide using minor variations from normal protocols. The assay takes 5 hours to run and is fully automated once slides are loaded and the instrument is started. The finished slides are held in a moisture-controlled environment, allowing a run to be started in the evening and retrieved in the morning. Slides are then examined and interpreted. A positive result can usually be found by scanning the slide. A negative result requires a full slide screen. Slides are archived with the corresponding cytology or tissue slides. A histotechnologist or cytoprep technician is required to prepare the slide. Most slides will be screened by a cytotechnologist. Interpretation of the slide requires a pathologist.

Reagents and other disposables purchased through Ventana's HPV program cost $35 per assay (list price). Use of the BenchMark stainer is included in the kit cost. The test slide is stained on a fully automated instrument, reducing labor costs. Slide preparation for an LBPT has both disposable and labor costs. The instrument has a maximum capacity of 20 slides per run, which must include at least 1 control slide per panel. Reagents for 1 control slide per full run (19 specimens) are provided. Additional control slides cost the same to process as specimen slides and will be required if partial runs or mixed panel runs are performed (cost information provided by L. Jensen-Long, Ventana Medical Systems, oral communication, November 2, 2002).

Medicare reimbursement averages $109 ($59 technical component, $50 professional component).12 The CPT code is 88365. The average reimbursement data are scant, and reimbursement is thought to be in the range of $135. This information should be considered speculative at this point and should not be used as a predictor of future reimbursements.

A break-even analysis requires evaluation of costs (see Table 1), reimbursements, and test volumes. This type of analysis provides greatest utility to individual laboratories when the assumed values of the variables are replaced with accurate laboratory-specific data. Common mistakes that overestimate profitability of a test include ignoring or underestimating indirect costs and laboratory overhead, failure to obtain reimbursement data from the laboratory's major providers or factor for bad debt, and overestimating demand for test utilization. A typical laboratory will lose $2.39 per test if the laboratory is compensated on only the technical component (ie, the pathologist bills separately for the professional component). However, if the laboratory bills globally for the assay (ie, the pathologist does not bill for the professional component), only 2 assays per run are required to break even. Full runs of 19 patient samples will produce a profit of about $44 per test. See Table 3 for assumptions. Reducing costs or increasing reimbursements will positively affect the break-even analysis. To generate 19 assays per week would require approximately 760 LBPTs per week. See Table 4 for assumptions.

This assay has several advantages. The test is profitable with lower volumes if the pathologist is not compensated. The BenchMark stainer can also perform immunoperoxidase and other special histology stains. The instrument is fully automated with walk-away capacity, while interpretation of the results is simple, intuitive, and gratifying. Visualization of HPV within cells can be educational and allows for more refined Papanicolaou diagnostics. The test can be done on both tissue and cytology specimens, including conventional Papanicolaou smears and archived Papanicolaou tests. Oncogenic and nononcogenic panels can be performed separately.

There are also unanswered questions regarding this assay. The test may have greater specificity for selecting patients with cervical intraepithelial neoplasia than the Digene assay without losing sensitivity. Such specificity could help reduce the number of colposcopies and contribute to high cost-effectiveness. However, if the assay does not reduce the number of colposcopies, the increased cost of the assay will be burdensome to the payers and the medical economy. The test may also be useful in resolving indeterminate tissue biopsies. The sensitivity of the assay may not be sufficient to warrant widespread clinical use.

Disadvantages of the assay include ASR labeling, which places an extra burden on the laboratory to assure the performance characteristics of the assay. Data supporting its value as a triage indicator for atypical squamous cells are very limited. The negative predictive value of this test is not well established. Using the test to triage patients to colposcopy before the sensitivity and negative predictive values are known is risky and has the potential to hurt patients, possibly introducing a new form of liability to the laboratory or clinician. Testing on specimens with rare atypical cells may produce false negatives. If the pathologist bills separately for the professional component, the laboratory cannot break even. Billing data should be considered speculative at this point and should not be used as a predictor of future reimbursements. The cost of the test is high for payers, which will likely provoke a decrease in payer reimbursement.

Polymerase chain reaction is a “home-brew” assay. Multiple HPV primers are available in the public and private domain. Polymerase chain reaction is a long-standing fundamental molecular testing technology and has many testing advantages. It may be the most effective, efficient, and versatile technology available and holds great promise for the future.

Polymerase chain reaction is a form of nucleic acid amplification testing. In PCR, small complementary nucleic acid strands called “primers” hybridize to sequences in DNA to form specific, double-stranded complexes with the template or “target” DNA. These primers are unique and specific for each organism being tested. From these primers, 2 copies of DNA are made with each round of amplification. During subsequent rounds of amplification, the copied DNA as well as the template DNA are used to make more copies, giving an exponential amplification. Starting with 1 strand of DNA, millions of exact copies can be made. This capacity gives nucleic acid amplification testing very high sensitivity and specificity.

Polymerase chain reaction products can be analyzed by different techniques, of which agarose gel electrophoresis and real-time analysis are 2 examples. In agarose gel electrophoresis, samples are separated by size in a gel with an electric current. Smaller fragments migrate through the gel at a faster rate than the larger ones. By running controls of known sizes, the size of the PCR products can be determined. Real-time analysis measures the amount of fluorescence produced as PCR product is formed. This measurement is done during amplification and thus is called real-time analysis. Real-time PCR is extremely accurate and precise. It also saves time because analysis takes place during the run rather than after the run, as in agarose gel electrophoresis. Genotyping of the amplified PCR product can be performed by different techniques, of which DNA sequencing, restriction endonuclease digestion with gel electrophoresis, and a slot-blot assay are 3 examples.

The workflow will vary in each laboratory, depending on the equipment and type of PCR testing that is used. In the author's laboratory, the assay takes 3 hours for 24 samples and 4 hours for 84 samples. The assay may be run on a real-time instrument, which makes results available at the end of the run. Test samples undergo DNA extraction, amplification setup, thermal cycling, and analysis. An experienced molecular scientist or medical technologist with molecular training is required to oversee the testing process.

Expenses will vary considerably in each laboratory, depending on the equipment and type of PCR testing that is used. Reagent and disposable costs are roughly $4 to $6 per test. Labor costs are about $2 to $4 per test, depending on the size of the run. The cost for real-time instruments ranges from $36 000 to $95 000. A PCR licensing agreement must be made with Hoffmann La Roche (Indianapolis, Ind), which includes a royalty on net revenue from billable specimens (15% on basic PCR, 18% on advanced PCR, and 20% on advanced PCR for organisms).13 

Reimbursement and CPT code are the same as for the Digene HC2 test for detection of HPV. Genotyping of the HPV has an additional set of CPT codes, depending on the method of the genotyping process. Breakeven occurs at about 10 tests per run and may vary considerably, depending on the type of PCR assay, equipment and reagents, and level of automation.

Polymerase chain reaction has the advantages of high-volume throughput capacity, relatively low labor costs, high specificity and sensitivity, and low operating cost. Specific viral types can be identified and viral loads determined. This capacity allows for accumulation of type-specific data, development of type-specific treatments, individual assessment of patient risk, and individual patient treatment. Intrinsic controls can verify the cellularity of a specimen, confirming specimen adequacy. The sample volume required is very small, and many instrument choices are available.

Polymerase chain reaction has several disadvantages as well. Specially trained technologists are required. Commercial kits are not available and tests must be designed in house. Patents on specific viral DNA sequences may restrict the use of the technology.

The HPV assay may not be a test that would be beneficial for most laboratories to run. There is no formula for determining if a test should be performed in house or sent out. Since the assay has the capacity to be a significant liability, it is useful to perform a careful cost analysis, volume analysis, and workflow analysis prior to setting up the assay. Most often the choice is based on financial factors, workflow issues, test volume, and service issues. With the fast pace of medical economics, we must also consider future factors, such as the duration of viability and utility of the current technologies and the stability of current reimbursement levels.

Factors that may support a choice to perform in-house testing include convenience, ability to enhance service, capacity to enhance profitability (in the case of larger volume laboratories or profitable reimbursements), underutilization of technical staff, avoiding competition, capacity to retain control of the process, ability to personally assure quality, ability to integrate and collect data, and the opportunity to gain experience with HPV testing. The fundamental question is “Does HPV testing in house significantly contribute to the objectives of the laboratory?”

Factors that may support a choice to outsource HPV testing include avoidance of financial loss (slim or negative profit margins, high kit costs, poor reimbursement), insufficient capital expenditure budget for equipment, insufficient time and expertise to set up testing, insufficient qualified testing personnel, insufficient specimen volume, workflow issues, and uncertainty regarding future reimbursements. Additional concerns could include responsibility for an ASR assay (Ventana Inform HPV) or home-brew assay (PCR) without significant data justifying its use in a triage protocol, or off-label use of an FDA-approved assay (Digene HC2 on SurePath specimens). The fundamental question is “Does outsourcing HPV testing significantly contribute to the objectives of the laboratory?”

The risk-reward analysis of in-house testing is complicated. Evolution of HPV testing technology and testing strategies is progressing rapidly, making it difficult to perform a reliable risk-reward analysis. The 3 primary HPV assays that are currently available are based in technology developed more than a decade ago. Significant advancements in testing have occurred that will produce new HPV assays that promise to be highly clinically useful (better), that are quick and simple (faster), and that cost a small fraction of the current assays (cheaper). I have seen 3 such assays, one of which I have used. Two of the assays are designed for point-of-care use and will likely shift much of HPV testing from the laboratory to the doctor's office. Market forces and practice efficiencies will drive such assays into medical practice and redesign the role of HPV testing. The current technologies will likely have a reduced role in medical practice or will be replaced entirely. This scenario raises numerous unanswerable laboratory economic questions: When will a shift in technology occur, if it does occur? What is the laboratory's future role in HPV testing? What does such testing mean in economic terms to my laboratory? Will I recover my capital investment in equipment? Will the interval and magnitude of testing profitability be sufficient to justify the effort to establish a viable HPV business? In the face of such unanswerable questions, it would be difficult to produce a reliable risk-reward assessment, and it may be simpler to step back and ask, “Is there a compelling reason why my laboratory should or should not do HPV testing?”

A laboratory can develop an interim HPV solution by partnering with a regional or national reference laboratory to perform the testing process. This strategy is particularly useful for laboratories that are working toward developing sufficient specimen volume to economically justify in-house testing. Steps toward phasing in HPV testing in this manner could include (1) selecting an appropriate laboratory partner willing to work with you to meet your objectives, (2) optimizing costs and reimbursements before bringing the test in house (negotiations with vendors, confirming/negotiating reimbursement rates from payers), (3) performing a careful cost analysis and determining the volume threshold at which in-house testing might begin, and (4) implementing client education and marketing to increase test volumes to the target threshold. Volume is critical and a laboratory should consider if it would require an educational or marketing program to produce sufficient volume.

Each laboratory will establish its own implementation process. The following information may facilitate efficient implementation.

The process begins with selection of a technology. Most laboratories with sufficient test volume could consider the Digene HC2 assay first. This assay offers FDA labeling and extensive supporting data. Some laboratories may choose the Ventana Inform HPV assay because of its higher profitability, lower requisite test volumes, and visual confirmation of results. Laboratories able to do DNA work may choose to develop PCR assays, owing to higher volume throughput capacity, greater cost-effectiveness, and greater diversity in the type and quality of information generated.

Lease and contract negotiations are critical. Diligence in this step may make the difference between financial viability and financial liability. All capital purchases, leases, reagent rentals, and kit costs are negotiable. Know what price you need and do not be afraid to ask for it. Determining this price requires research. Since some costs are not initially apparent, an additional margin should be factored into the calculation. In this area of rapidly evolving technology, long-term leases may prove burdensome and limit an institution's ability to evolve with the technology.

Schedule education, installation, and training well in advance. The availability of technical service personnel may be limited. Consider educating a sales and marketing staff to support a clinician education and marketing campaign.

The purpose of in-house validation is to demonstrate that the instrument, reagents, personnel, and protocol are producing the intended results in your laboratory. Validation of the Digene HC2 test is relatively simple; it may be sufficient to run and compare results for 20 known positive and negative samples. Write up the findings and conclusions in a validation report. Discrepancies must be addressed. Validation of the Ventana ASR technology may be more complex, depending on the judgment of the medical director, owing to the small amount of available supporting data. Validation of PCR assays should be designed by the technical supervisor and approved by the medical director in congruence with standard PCR validation procedures. During validation of the Digene HC2 assay, consider using only negative specimens with an RLU/co less than 0.6 and positive specimens with an RLU/co greater than 5 to avoid borderline results.

Establish quality assurance indicators and proficiency testing. Quality control is built into the calibrators for the Digene HC2 assay. Separate quality control samples are not required in the run. Laboratories may benefit from making their own positive and negative controls from pooled specimens and including them in the run. Tracking the RLU/co values for this type of sample control provides an extra level of quality assurance and insight into the stability of the specimen DNA. One good quality assurance indicator for the Digene HC2 assay would be to monitor the frequency of oncogenic HPV types in atypical squamous cell specimens. Oncogenic HPV types have been found in about 50% to 60% of atypical squamous cell specimens.1,6 Separate quality control slides should be run with each Ventana Inform HPV run. Quality control for PCR is designed in congruence with the nature of the particular PCR assay. Quality assurance indicators should be developed for both the Ventana and PCR assays.

Assure that all regulatory issues have been addressed, including policies, procedures, notification of regulatory agencies, arrangement for proficiency testing, tracking of quality assurance indicators, verification of laboratory information system data storage/retrieval, and distributing appropriate information to providers that are submitting specimens.

For years, HPV testing was a relatively small, unnoticed component of the medical economy, struggling to find its place in medical diagnostics. Reimbursements for HPV tests had previously been relatively high, capital costs modest, and test volumes low, which minimized both the positive and negative financial impact for most participants. This relatively comfortable state has been changing considerably owing to the financial impact of rising utilization on payers. Payers may see this rise in utilization as a significant expansion of a single line-item cost, rather than a component of a cost-effective protocol that will reduce overall cancer screening costs. Controlling this type of rising cost is intrinsic to the process. Hence, many payers are cutting HPV test reimbursement. In the author's laboratory, analysis of the top 10 payers (62% of insurance bill specimens) shows that average reimbursement dropped in the last 4 years, and only 2 payers have increased reimbursements. In spite of these increases, 5 payers reimburse less than cost (some Altius, Intermountain Health Care, United Health Care, and Healthy U plans) and 2 reimburse at cost (some Blue Cross/Blue Shield, Valucare plans), generating a slight net loss. As costs continue to rise, the profitability of the test falls.

This scenario of declining reimbursement is very similar to what pathology laboratories experienced in the early 1990s for their Papanicolaou test business and again in the late 1990s with the introduction of LBPTs. Payers saw a growing cost center in Papanicolaou testing and beyond a certain threshold were driven to take action to reduce reimbursement costs. As laboratories learned during those Papanicolaou reimbursement cycles, payers reprice a test because in total that test is a significant expense line item. Whether the laboratory can cover its costs or the test reduces overall health care cost is often irrelevant.

A privately commissioned analysis of the HPV marketplace reached the following conclusions14:

  • growing demand for HPV testing will attract payer attention on pricing;

  • reimbursements will likely get worse before they get better;

  • economic casualties will occur for both payers and service providers in the short run;

  • new testing strategies or assays will be introduced that provide significant competition for current manufacturers, resulting in reduced laboratory costs; and

  • relative equilibrium will emerge, and the survivors will be those companies with the volume, scale, and technological capability to provide the lowest processing cost and highest value test (eg, genotyping).

The diagnostic usefulness of HPV testing, particularly genotype HPV testing, is rapidly expanding the utilization of this test. The Digene test alone has been showing 33% annual growth,15 and this market is nowhere near saturation. Whether HPV testing becomes a primary screening tool or just remains a follow-up for a diagnosis of atypical squamous cells will determine if it is to be a potential $500 million market or a multi-billion dollar market. Either way, those numbers represent a direct cost to payers, and doctors can expect them to take action to drive down the cost of this test.

To some extent, a laboratory can counteract declining reimbursement by continually introducing new technology with greater predictive value. However, a laboratory looking at entering the HPV market should count on a reduction in reimbursement rates and accordingly structure its operating costs.

Human papillomavirus testing is becoming an important tool for detecting cervical cancer. Laboratories that perform Papanicolaou testing are faced with the challenge of offering an HPV testing service. Three HPV technologies are currently available, each with distinct advantages and disadvantages. Careful consideration should be given as to performing the test in house or sending it out. Substantial testing volumes will be required for cost-effectiveness. Adequate reimbursement may become the major financial issue. Human papillomavirus testing technology and its role in cancer screening strategies are likely to evolve in the near future.

The following individuals contributed to the research or writing of this article: Randall E. Bolick, MS; Faye Coates, MLT(ASCP); Craig M. Daniels, BBA; Michael B. Juretich, MT(ASCP); Kirk Ke Lin, MD; Barbara L. Piper, BA; Lisa Cummings, MBA; Mark J. Rosenfeld, PhD; Frank L. Spangler, MS; Brian E. Staley, MD; Bradford E. Willmore, MBA; and Douglas Willmore, BS, MPA.

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Presented at the College of American Pathologists Strategic Science Series Conference, HPV Testing: Are You Ready for a New Era in Cervical Cancer Screening?, Rosemont, Ill, September 21–22, 2002.

Author notes

Reprints: David R. Bolick, MD, AmeriPath-Utah, 10011 Centennial Pkwy, Suite 300, Sandy, UT 84070 ([email protected])