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Automated screening technologies becoming widely accepted
Automation of pathology testing in clinical laboratories is growing rapidly. With a number of new systems for automated reading and preparation of Pap-smear slides already approved by FDA, automated equipment for diagnosing other diseases or conditions is now in the works. Despite having to overcome such hurdles as poor reimbursement rates and sometimes almost prohibitive laboratory start-up costs, the technology is now being readily adopted.
NeoPath (Redmond, WA) and AutoCyte (Burlington, NC) may be leading this trend. The companies have recently agreed to merge, pending shareholder and regulatory approval. The merger should be final by October 1999, according to the as yet unnamed new company.
ChromaVision Medical Systems's Advanced Cellular Imaging System.
"The merged companies will offer AutoCyte's Prep System liquid-based thin-layer slide preparation technology," says James B. Powell, MD, president and CEO of the merged companies. "We will also offer NeoPath's AutoPap primary screening system, which is the only FDA-approved device for automated primary screening of conventional Pap smears."
The firms are currently conducting a joint clinical trial for the screening of Prep slides by AutoPap. They expect to file for FDA approval this month, according to Ernie Kmesel, chief operating officer at AutoCyte.
"The combination of thin-layer slide preparation technology and automated primary screening of both thin-layer and conventional Pap smears is expected to create a unique, comprehensive and cost-effective product offering for clinical laboratories," says Powell.
A recent study published in the Journal of the American Medical Association concurs. The study evaluated the cost-effectiveness of automated Pap-smear screening, and found significant benefits. The cost per life-year saved was calculated at $20,000 for automated Pap screening compared with $44,500 for mammography and $46,000 for hypertension screening.
Automated screening offers the ability to read cytology slides more accurately than can be done manually, according to ARUP Laboratories (Salt Lake City). Within the first three months of using AutoPap, ARUP detected what appeared to be a significant increase in high-grade and low-grade squamous intraepithelial lesions compared with those found through random 10% manual QC screening. "It shocked us at first," says Jay Marshall, MD, ARUP's medical director of cytopathology. "There is a significant false-negative error rate due to screening error," he says.
In traditional laboratory settings, cytotechnologists typically do not sign out their own work without a pathologist reviewing it. This can lead to long hours for the pathology staff. Automated screening technologies can help reduce this workload. At Palomar Medical Center Laboratory (Escondido, CA), adoption of the AutoPap system required the addition of about half a full-time equivalent clerical position to handle sorting of slides and paperwork, says William D. Tench, MD, associate director and chief of anatomic services. However, long hours for pathology staff have decreased. Now, if the sample is not from a high-risk patient and the instrument places the slide in the "no review" category, the smear is not reviewed by a pathologist. "This has reduced pressure on the pathologists," says Tench. "They have more time to work on difficult cases."
In spite of its increased accuracy and positive effect on lab personnel, not all insurance companies are willing to pay for such automated screening technologies. In March 1998, in order to maximize reimbursement, NeoPath put together a team that helps laboratories obtain appropriate reimbursement from insurance companies and managed-care organizations. "Improved reimbursement is a key element in making this innovative technology available to a greater number of women for the early detection of cervical cancer," says Alan C. Nelson, chairman of the merged companies.
Assessment of neutrophil alkaline phosphatase in white blood cells.
The tactic seems to be working, at least in California. The state's Medicaid program, Medi-Cal, started offering reimbursement for AutoPap in June 1999. Other states may follow suit. "We believe California may lead other state Medicaid programs to reimburse for AutoPap," says Ronald R. Bromfield, president and CEO of NeoPath.
Until that happens, labs have developed their own strategies for reimbursement. Palomar Medical Center Laboratory separately bills $20 for Pap smears evaluated by AutoPap, but not for other Pap smears. An analysis by Palomar's billing company determined that this surcharge would cover the laboratory's costs, given that the additional fee would not always be recouped.
Some insurers will pay for a Pap smear but not for use of an automated system. In these cases, patients are billed for the balance. Most patients pay this cost, says Tench. "They recognize that it's important."
ARUP Laboratories and Penrose Hospital laboratory (Colorado Springs, CO) raised their base Pap-smear price to cover the cost of AutoPap. This was done partly to simplify billing but also because "the overall quality of the laboratory was improved by the testing," says ARUP's Marshall. Officials at both labs believe that the increases cover their additional expenses.
With the problem of inadequate reimbursement behind them, the merged companies are branching out into diagnosing other diseases. NeoPath and Bayer Diagnostics (Tarrytown, NY) have entered into a collaborative research agreement to develop an automated screening system for the detection of early lung cancer. The two companies will combine NeoPath's visual intelligence technology with Bayer's antibodies to screen for precancerous changes in cells found in sputum samples. A preclinical prototype demonstrating the system's performance is scheduled to be completed by the end of the year.
ChromaVision Medical Systems (San Juan Capistrano, CA) also has an automated technology that has recently been approved for diagnostic use by FDA. The Automated Cellular Imaging System (ACIS) can be applied to many existing laboratory diagnostic tests and is designed to enhance a physician's ability to detect disease at the cellular level. The ACIS combines proprietary, color-based imaging technology with automated microscopy to increase detection sensitivity more than 300% over manual testing methods.
The first applications of the ChromaVision system are on the horizon. "Objective measurement of HER2/neu protein expression will be released in September," says ChromaVision's director of marketing, David Weisenthal. "There is an acute need for this test because HER2 testing identifies patients who are qualified candidates for treatment with Herceptin. There is concern among clinicians that current manual scoring methods are not sufficiently accurate and reproducible."
According to the company, other cancer applications will also be released this year, including assays for sentinel lymph node metastasis, estrogen receptor, progesterone receptor, Ki-67, p53, and EGF-R.
ChromaVision doesn't anticipate any major reimbursement hurdles. "The AMA coding committee advisory service has verified that ACIS-based procedures are billable under existing CPT codes," says Weisenthal. "In any event we are prepared to support ACIS users with reimbursement assistance to whatever degree they may require it."
Specialty Laboratories (Santa Monica, CA) has two ACIS instruments and is planning to be the first national reference laboratory to offer ACIS-based, ultrasensitive detection of micrometasteses in bone marrow. Other labs have been using ACIS instruments for research purposes and will now use them for clinical applications.—S. W.
Photos courtesy of Chromavision Medical Systems.
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