AutoCyte Moves One Step Closer To FDA Approval

AutoCyte needs FDA decision to become newest competitor in automated cytology

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CEO SUMMARY: Until now, AutoCyte has kept a relatively quiet presence in the automated cytology marketplace. That may soon change as the FDA takes action on the company’s PREP™ and SCREEN™ products. AutoCyte expects these products will boost productivity and quality in cytology labs. AutoCyte’s product positioning will be very different than its competitors: NeoPath, Neuromedical Systems, and Cytyc.

RECENT ACTIONS AT THE Food and Drug Administration (FDA) moved one AutoCyte, Inc. product forward and delayed approval on the other.

AutoCyte, based in Burlington, North Carolina, received a request from the FDA for additional information to support AutoCyte’s premarket approval application (PMA) for the company’s PREP™ product.

PREP is an automated system for preparing thinlayer Pap smears. AutoCyte was hoping that the FDA would make a positive decision on PREP in September, so the request for additional information will delay FDA action on that product.

News ismore positive forAutoCyte’s SCREEN product. “Clinical trials for SCREEN are completed and the FDA has all the necessary information required to act upon our PMA,” stated James B. Powell, M.D., President and CEO ofAutoCyte. “We now await notice from the FDA as to how they will proceed in evaluating the SCREEN PMA.”

AutoCyte’s SCREEN product is designed to work in tandem with its PREP system. SCREEN technology combines image analysis with classification software to screen Pap smears.

AutoCyte’s intent to offer an integrated cytology system sets it apart from its competitors. “We had three goals in starting this company. It is what distinguishes us from other companies in the automated cytology field,” said Dr. Powell.

“Every area of the laboratory but cytology and histology has been helped by automation. That will change in the coming years as a stream of new automated products for these departments hits the market.”
James B. Powell, M.D.
President & CEO, AutoCyte, Inc.

“Our first goal is to develop an automated liquid-based preparation system [mono-layer],” he continued. “We believe that removing unnecessary material from the Pap smear slide is essential to improve the speed of the screening process, its quality, and its accuracy.

“Our second goal is to develop a unified, automated system of preparation and screening where individual components can work together as well as individually,” noted Dr. Powell. “This gives laboratories maximum flexibility to incorporate our products into their particular situation.”

System To Be Interactive

“The third goal is something we believe sets us apart from competing systems. We want our SCREEN system to be interactive with the cytotechnologist,” said Dr. Powell. “We want to use the best features of automation to enhance and compliment the experience and skills of cytotechnologists.

“In looking at current work practices, we believe that automating the primary
screening process has the best potential to enhance productivity and quality in the cytology laboratory. This is the step where a laboratory identifies slides as having either normal or abnormal cells.

“We are designing our systems to improve the speed of the initial sort between normal and abnormal,” he added, “while at the same time improving quality and accuracy in the detection of abnormal cells on the individual Pap smears.”

Cytology Will Consolidate

“The reason we took this direction is that we believe cytology will consolidate
into larger processing centers. It will follow a similar path as the consolidation of clinical laboratory testing in recent years,” predicted Dr. Powell. “As cytology consolidation occurs, it is necessary to provide cytotechnologists with tools which improve their productivity and their accuracy. That is the design philosophy behind our PREP and SCREEN products.”

According to Dr. Powell, laboratories participating in development and clinical trials for PREP and SCREEN are accumulating information about the performance of the systems. “Early data indicates that cytotechs can become four or five times more efficient with our SCREEN system.

“For example, our systems are in use by a laboratory in Australia,” he noted. “Its experience is similar to that of laboratories in the United States. Time trials done to date document that cytotechs average one and a half to two and a half minutes per slide with our SCREEN system, compared to eight to ten minutes per traditional Pap smear. Quality improves as well.”

As the FDA evaluation process moves forward with AutoCyte’s SCREEN PMA, a favorable decision by the government agency will permit a new competitor to enter the market for automated cytology.

Moment Of Truth

That will be the moment of truth for AutoCyte. Reimbursement for conventional Pap smears is currently at an uneconomically low level. Laboratory customers remain skeptical about the economics of acquiring and using automated technology which has entered the market to date.

Conventional Pap smear testing remains a difficult market niche, given malpractice trends, shortages of trained cytotechs and poor reimbursement. In contrast, automated cytology technology has the potential to eventually improve the reimbursement situation.

AutoCyte’s product positioning strategy is unique. It will offer an integrated system capable of Pap smear preparation and Pap smear screening. It is interactive with cytotechs. Both characteristics set Autocyte apart from its three primary competitors in the automated cytology marketplace.

Laboratory Industry Leader Offers Insights About Future

WHAT IS THE FUTURE for cytology and anatomic pathology? Dr. James Powell provides interesting observations about what lies ahead.

“Cytology and histology are the last areas of laboratory medicine to be addressed,” stated Dr. Powell, President and CEO of Autocyte, Inc. “The effort to apply automation and productivity tools to cytology and histology has lagged
behind those in other departments of the clinical laboratory.

“As operators of large clinical laboratories, we recognized the need to improve productivity in cytology and histology,” he added. “It’s an opportunity to apply new technologies to solve problems in these areas of the lab.”

DARK REPORT clients should pay close attention to Dr. Powell’s comments about future directions for cytology and the laboratory industry. Dr. Powell founded Biomedical Laboratories in Burlington. His laboratory was purchased by Roche and renamed Roche Biomedical Laboratories.

Roche later acquired National Health Laboratories, and the merged laboratory is known today as Laboratory Corporation of America. Dr. Powell was President and CEO of LabCorp until the beginning of 1997, when he resigned to pursue other business interests such as AutoCyte.

AutoCyte, Inc. was initially organized to develop automated cytology systems. But Dr. Powell and his executive team also have their eyes on the needs of anatomic pathology as well.

“We believe that cytology will increasingly be consolidated into larger volume laboratories,” stated Dr. Powell. “Given that fact, it is essential for our industry to develop tools which enhance the productivity, accuracy, and effectiveness of a cytotechnologist.

Dr. Powell believes that cytology automation will require cytotechs, but in different roles than simply screening Pap smears through a microscope. He also believes that new technology moving through the pipeline will affect the way
cytology and other aspects of anatomic pathology are practiced.

“Imagine how emerging technologies could be applied to anatomic pathology,” observed Dr. Powell, “As image capture systems become faster and more detailed, they should, for example, make measurement of the quantity of DNA speedy and accurate. New clinical studies indicate the quantity of DNA is directly relevant to cancer diagnostics and prognostics. Other tumor markers and HPV testing will be incorporated into the diagnosis of cervical cancer.

“Such technology would make it easier and faster for pathologists to evaluate specimens and make more precise and detailed diagnoses,” he explained. “Such tools would permit pathologists to provide clinicians with quantitative and significantly more useful information about each patient.

“I fully expect that technology is going to eventually be applied to all areas of anatomic pathology,” said Dr. Powell. “It will include reading specimens, archiving specimens and the data associated with them, performing tumor markers, DNA, and HPV analysis, and the teletransmission of pathology images
and information.

“AutoCyte would like to be in the forefront of these developments,” continued Dr. Powell. “Our primary business goal is to develop new tools to help cytotechnologists and pathologists improve clinical practices.”

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