CEO SUMMARY: It is time for pathologists and cytologists to buckle their safety belts. The marketplace for automated cytology is entering a new cycle of rapid change. NeoPath’s AutoPap System is now poised to demonstrate that it is economical and clinically viable. Expect continual improvements to automated cytology technology to eventually replace traditional methods of diagnosing Pap smears.
A NEW ERA OF CYTOLOGY was launched when the Food And Drug Administration (FDA) formally approved NeoPath, Inc.’s AutoPap® System for use as a primary screener of Pap smears.
NeoPath announced the FDA’s approval on May 7. Earlier in January the FDA’s Hematology and Pathology Devices Advisory Panel had recommended to the FDA that it approve the AutoPap System for primary screening.
Not only is this FDA approval an important milestone for NeoPath, but it is a seminal event for the entire cytology industry. This is the first time that the FDA has approved a machine to replace a human in the diagnosis of a cytology specimen.
Marks The Beginning
It marks the beginning of a transition from a cytotechnologist-driven process of evaluating Pap smears to a process dominated by machines, with humans involved in the review and QA/QC process.
The FDA’s action came in response to a pre-market approval (PMA) supplement submitted by NeoPath. As requested by NeoPath, the approved supplement allows the AutoPap System to classify up to 25% of the Pap smears as normal. These slides would be reported out as normal and archived without human review.
It marks the beginning of a transition from a cytotechnologist-driven process of evaluating Pap smears to a process dominated by machines…
The remaining 75% of the slides are prioritized by the AutoPap System according to the probability of their containing abnormal cells. These slides are sent to cytotechs for human review, along with the priority ranking of abnormality. Quality control rescreening will be done to 15% of the slides in both groups of Pap smears.
NeoPath was prepared to act immediately once FDA approval was granted. The company had earlier announced a financing agreement with Rockford Industries, Inc. of Santa Ana, California. This agreement makes it possible for NeoPath to offer a full range of purchase and lease options for laboratories which are interested in acquiring the AutoPap System.
This is in keeping with NeoPath’s focused and deliberate marketing plan. Since 1995, when the FDA approved the AutoPap System for rescreening and adjunctive testing, NeoPath has successfully placed units with the major laboratory companies in the United States. It has also placed units with some large HMOs, such as Kaiser Permanente.
Laboratories doing a high volume of Pap smears have been the first to acquire AutoPap Systems. There are at least three laboratory sites in the United States today where ten or more AutoPap units operate daily. The volume of Pap smears read by AutoPap Systems monthly is increasing.
One Question Mark
One question mark that continues to plague the introduction of all automated cytology technology is the reimbursement issue. If laboratories cannot recover their costs and a reasonable profit from such systems, they have little incentive to acquire and use this technology.
For that reason, NeoPath is working diligently to gain reimbursement determinations from major managed care companies (MCOs). The day after the FDA approval was announced, NeoPath released information that Blue Cross/Blue Shield organizations in ten states had issued reimbursement determinations. Six other major MCO organizations in five states similarly made reimbursement determinations in favor of the AutoPap System.
The PMA supplement approved by the FDA was based upon clinical data from a study of 25,000 Pap smears diagnosed in five laboratories.
The study demonstrated that AutoPap helped the participating laboratories detect 33% more suspicious cells, including two possible cancers that were missed by cytotechs involved in the study. Interestingly, the device missed 11 of 4,800 slides it had designated as low risk. But according to Susan Alpert, M.D., FDA device evaluation chief, they were of the least suspicious type.
The First Step
Acceptance within segments of the medical community lags because Pap smear screening is just the first step in the detection process. “This device… tells you that something is abnormal,” stated Ted Gansler, M.D., Director of Health Content at the American Cancer Society. “It removes the most tedious and stressful part of the Pap testing, which is identifying the abnormal cases.
“One of the most difficult things about Pap tests,” continued Dr. Gansler, “is that, unlike many other types of specimens where you immediately see an abnormality, in the case of looking at Pap smears the first step is to find something. If you lose concentration for a minute, it could mean that you miss something that has life-or-death implications.”
Primary screening of Pap smears by automated cytology technology is now a fact. NeoPath’s AutoPap System is the first to gain FDA approval. But other automated systems are in the approval pipeline. Probably within two years, several other systems will get regulatory approval and enter the marketplace.
Developments in the field of automated cytology demonstrate how fast the market is changing. Clinical laboratories offering cytology services should keep a close watch on these developments, because they are changing the underlying economics of Pap smear testing.