SOMEONE ALWAYS HAS TO BE FIRST to adopt new technology. In the case of automated cytology, it will be SmithKline Beecham Clinical Laboratories (SBCL).
SBCL and NeoPath, Inc. announced a four-year national agreement between the two companies on October 9 which will eventually allow SBCL to process 100% of its annual Pap smear volume using NeoPath’s AutoPap® Primary Screening System.
SBCL screens more than 5.5 million Pap smears annually, so this is a major development in the field of cytology. Among the three blood brothers, it places SBCL in the forefront and represents a bold management decision to be the “early adopter” for this technology.
Right Course Of Action
Clients of THE DARK REPORT are the first to get inside knowledge about why SBCL considered this to be the right course of action. In a candid interview, Edward A. Kaufman, M.D., Vice President and National Medical Director for SmithKline Beecham Healthcare Services discussed some of the science and operational considerations which led to its contract with NeoPath.
“Our clinical experience with NeoPath started when we acquired their AutoPap QC system back in 1995,” stated Dr. Kaufman. “Once installed in our designated laboratories, the system proved the concept by improving our rate of detection.
“To be specific, this system allowed us to detect five times more false negative low grade lesions or worse,” he said. “We detected eight times more false negative high grade lesions or worse. These numbers were a strong validation of the potential for automation to improve a manual process.”
Working With The System
“Once the AutoPap Primary Screener was available, we began working with that system,” continued Dr. Kaufman. “Set to screen at 50% ‘no review,’ the system performed as well as humans. Set to screen at 25% ‘no review’ [the level approved by the FDA for primary screening], the AutoPap System was definitively better than humans.
“This hands-on experience was critical to our belief that the AutoPap Primary Screening System could deliver both clinical and operational benefits in a high-volume commercial cytology laboratory,” he added. “Another key influence was the Blue Cross/Blue Shield study. Released earlier this year, it evaluated the cost-effectiveness of several automated cytology technologies. It gave the AutoPap Primary Screening System a favorable evaluation.
“In using the AutoPap technology, we saw improved sensitivity and specificity,” Dr. Kaufman observed. “There were fewer false negatives and there were fewer false positives. Within our cytology labs, the number of slides referred to pathologists for review declined. The consequences of improving the screening step ripple through the entire laboratory and give the clinician and his patient a more accurate Pap smear diagnosis.”
Because the AutoPap Primary Screening System is interactive with cytotechs, their response and input was a factor in SBCL’s decision. “Initially there was some apprehension by cytotechs when these instruments first appeared in their laboratories,” recalled Dr. Kaufman. “But as cytotechs began working with these instruments, three interesting things resulted.”
Cytotechs More Involved
“First, many cytotechs become more involved in the screening process,” he continued. “It captured their attention and caused them to rethink the science behind the Pap smear. Second, they became intrigued by what AutoPap does and how it applies innovative technology to screen a Pap smear.
“Third, a significant number of cytotechs liked the way the instrument was “teaching” them. When the cytotechs get the 75% of the slides requiring manual review, they also get AutoPap’s ranking in order of possible abnormality. The objectivity of this feed-back loop appealed to many cytotechs.”
From an operational standpoint, SBCL expects modest benefits from the current generation of AutoPap technology. “We don’t see a big impact in turnaround time, for example,” responded Dr. Kaufman. “For the 25% of the results which are ‘no review,’ they can be reported within 24 hours. The other 75% of the slides still under-go a manual review.”
Handle More Pap Smears
“It does give us additional capacity for handling more Pap smears,” he noted. “This is important in localities where there is an absolute shortage of trained cytotechs. It is also important for us where we gain additional business, such as from our new contract with Aetna/U.S. Healthcare. The AutoPap instruments free up our cytotechs to handle the new volumes of testing from such contracts.”
In developing national contracts with large HMOs, SBCL has emphasized its system-wide information system capability. The potential of AutoPap to feed data into that information system appealed to SBCL.
“We recognize that AutoPap can capture data in a useful way,” said Dr. Kaufman. “We would like to eventually retrieve that data and compare the Pap smear findings with biopsies and subsequent Pap smears for individual patients. We believe that matching these data sets can generate additional knowledge about how to diagnose and treat particular patients. For example, can it help us identify which cervical dysplasias will develop into real dis- ease, namely cervical carcinomas, and which will not?
“These opportunities do not exist today, because manual screening procedures cannot capture quantitative cytological information the way AutoPap does,” added Dr. Kaufman. “We anticipate that linking these algorithms with other data sets will allow us to identify useful relationships.”
Reimbursement An Issue
As with any new healthcare technology, reimbursement is an issue. SBCL believes that payers will respond favorably to the clinical performance of AutoPap as a primary screener. “Most managed care organizations (MCO) are just beginning to evaluate automated cytology,” observed Dr. Kaufman. “It will take time for the HMOs to gain experience with all aspects of automated cytology technology.
“From a strategic perspective, we think that the demonstrated gains in sensitivity and specificity for automated Pap smear screening will be recognized,” he said. “Improvements in the rates for false positives and false negatives create a variety of benefits for patients, clinicians, and the payers.
“At SBCL, our message will be one of accuracy. We think consumers, physicians and the healthcare community will respond to that message. It is a better Pap smear.
“Whether automated cytology screening for Pap smears becomes the standard of care is something which will be determined by clinicians, professional associations, government healthcare agencies, and similar experts,” continued Dr. Kaufman. “Because this technology is still new and unfamiliar, it will take a while for the clinical community to understand the impact it can have for improving healthcare outcomes.”
Committed To Technology
Overall, Dr. Kaufman was clear about SBCL’s evaluation of the AutoPap Primary Screening System. “This is a technology to which SBCL is committed,” he said. “In hands-on usage, this instrument has demonstrated compelling reasons for our company to move ahead and introduce this technology throughout our system.
“We are confident that its potential to improve the screening and diagnosis of Pap smears will be recognized by all segments of the healthcare community,” concluded Dr. Kaufman.
For pathologists and clinical laboratory executives, the move by SBCL to acquire and incorporate this technology should not be underestimated. On one hand, it is a sign that this technology is maturing. On the other hand, it is evidence that the marketplace is ready to raise the standards for what type of Pap smear processing represents highest quality for the patient.