TriPath Imaging Reports Discussions With FDA

Apr 02, 2001, 01:00 ET from TriPath Imaging, Inc.

    BURLINGTON, N.C., April 2 /PRNewswire/ --
     TriPath Imaging, Inc. (Nasdaq:   TPTH) ("TriPath Imaging" or "the Company")
 announced today that it is in discussions with the U.S. Food and Drug
 Administration ("FDA") regarding the Company's application to expand the
 claims for the AutoPap(R) Primary Screening System ("AutoPap") to include the
 screening of AutoCyte PREP System(TM) (AutoCyte PREP) thin-layer preparations
 on the AutoPap.
     In an amendment to its PreMarket Approval (PMA) supplement for the
 AutoPap, TriPath Imaging submitted data from a prospective, masked clinical
 trial in which thin-layer slides, prepared using the AutoCyte PREP, were
 processed on the AutoPap and screened by laboratory personnel.  Approval of
 the AutoCyte PREP and AutoPap system combination would enable TriPath Imaging
 to offer laboratories the first automated screening solution for both
 conventional and thin-layer preparations.
     As a result of ongoing discussions with the FDA, the Company believes that
 it will have various options in connection with the pending PMA supplement.
 Among these are to accept limitations in TriPath Imaging's proposed product
 labeling or to collect additional data to support the current labeling
 proposal.  Paul R. Sohmer, M.D., Chairman, President and CEO of TriPath
 Imaging stated, "We are evaluating our options and are considering the best
 course of action.  We continue to look forward to FDA approval."
     In connection with its submission, TriPath Imaging has voluntarily brought
 to the FDA's attention several assertions recently made by a former Company
 employee questioning the use of the AutoPap to screen thin-layer preparations.
 The Company has conducted an internal investigation and has determined that
 these assertions appear to be without merit.  The FDA has advised the Company
 that it will conduct an inspection to investigate these assertions prior to
 completing agency review of the Company's PMA supplement.  Dr. Sohmer
 commented, "Given the essential role that the AutoPap and the AutoCyte PREP
 play in improving the quality of healthcare, we wanted to bring this to the
 FDA's attention.  We will cooperate fully with the FDA in its inspection."
     TriPath Imaging develops, manufactures and markets products to improve
 cancer screening.  Improved slide preparation technology is delivered through
 the AutoCyte PREP System(TM), a proprietary automated thin-layer cytology
 sample preparation system that produces specimen slides with a homogeneous,
 thin-layer of cervical cells, and is one of only two sample preparation
 systems approved by the FDA as a replacement for the conventional Pap smear.
 TriPath delivers visual intelligence technology to increase accuracy and
 productivity in medical testing through the AutoPap(R) Primary Screening
 System, which utilizes proprietary technology to distinguish between normal
 Pap smears and those that have the highest likelihood of abnormality.  In May
 1998, AutoPap was approved by the U.S. Food and Drug Administration as the
 first and only fully automated device for primary screening of Pap smear
 slides.
 
     Forward-looking statements in this release are made pursuant to the safe
 harbor provisions of the Private Securities Litigation Reform Act of 1995.
 Investors are cautioned that statements in this press release which are not
 strictly historical statements constitute forward-looking statements which
 involve risks and uncertainties including, without limitation, risks
 associated with uncertainties regarding FDA approval, uncertainties regarding
 market acceptance and additional cost, risks associated with technological
 change, the Company's history of operating losses and the uncertainty of
 future profitability, dependence on a limited number of products, dependence
 on third-party reimbursement, limited marketing and sales experience, limited
 number of customers and lengthy sales cycle, risks of adverse changes in
 general economic conditions, and in the healthcare industry specific risks
 associated with competition and competitive pricing pressures, and other risks
 detailed in the Company's filings with the Securities and Exchange Commission.
 
     Contact: Dr. Paul R. Sohmer, President & Chief Executive Officer, James D.
 Everhart, Director of Finance and Treasurer, or Kathryn E. Johnson, Manager of
 Corporate Communications and Investor Relations, all of TriPath Imaging, Inc.,
 336-222-9707
 
 

SOURCE TriPath Imaging, Inc.
    BURLINGTON, N.C., April 2 /PRNewswire/ --
     TriPath Imaging, Inc. (Nasdaq:   TPTH) ("TriPath Imaging" or "the Company")
 announced today that it is in discussions with the U.S. Food and Drug
 Administration ("FDA") regarding the Company's application to expand the
 claims for the AutoPap(R) Primary Screening System ("AutoPap") to include the
 screening of AutoCyte PREP System(TM) (AutoCyte PREP) thin-layer preparations
 on the AutoPap.
     In an amendment to its PreMarket Approval (PMA) supplement for the
 AutoPap, TriPath Imaging submitted data from a prospective, masked clinical
 trial in which thin-layer slides, prepared using the AutoCyte PREP, were
 processed on the AutoPap and screened by laboratory personnel.  Approval of
 the AutoCyte PREP and AutoPap system combination would enable TriPath Imaging
 to offer laboratories the first automated screening solution for both
 conventional and thin-layer preparations.
     As a result of ongoing discussions with the FDA, the Company believes that
 it will have various options in connection with the pending PMA supplement.
 Among these are to accept limitations in TriPath Imaging's proposed product
 labeling or to collect additional data to support the current labeling
 proposal.  Paul R. Sohmer, M.D., Chairman, President and CEO of TriPath
 Imaging stated, "We are evaluating our options and are considering the best
 course of action.  We continue to look forward to FDA approval."
     In connection with its submission, TriPath Imaging has voluntarily brought
 to the FDA's attention several assertions recently made by a former Company
 employee questioning the use of the AutoPap to screen thin-layer preparations.
 The Company has conducted an internal investigation and has determined that
 these assertions appear to be without merit.  The FDA has advised the Company
 that it will conduct an inspection to investigate these assertions prior to
 completing agency review of the Company's PMA supplement.  Dr. Sohmer
 commented, "Given the essential role that the AutoPap and the AutoCyte PREP
 play in improving the quality of healthcare, we wanted to bring this to the
 FDA's attention.  We will cooperate fully with the FDA in its inspection."
     TriPath Imaging develops, manufactures and markets products to improve
 cancer screening.  Improved slide preparation technology is delivered through
 the AutoCyte PREP System(TM), a proprietary automated thin-layer cytology
 sample preparation system that produces specimen slides with a homogeneous,
 thin-layer of cervical cells, and is one of only two sample preparation
 systems approved by the FDA as a replacement for the conventional Pap smear.
 TriPath delivers visual intelligence technology to increase accuracy and
 productivity in medical testing through the AutoPap(R) Primary Screening
 System, which utilizes proprietary technology to distinguish between normal
 Pap smears and those that have the highest likelihood of abnormality.  In May
 1998, AutoPap was approved by the U.S. Food and Drug Administration as the
 first and only fully automated device for primary screening of Pap smear
 slides.
 
     Forward-looking statements in this release are made pursuant to the safe
 harbor provisions of the Private Securities Litigation Reform Act of 1995.
 Investors are cautioned that statements in this press release which are not
 strictly historical statements constitute forward-looking statements which
 involve risks and uncertainties including, without limitation, risks
 associated with uncertainties regarding FDA approval, uncertainties regarding
 market acceptance and additional cost, risks associated with technological
 change, the Company's history of operating losses and the uncertainty of
 future profitability, dependence on a limited number of products, dependence
 on third-party reimbursement, limited marketing and sales experience, limited
 number of customers and lengthy sales cycle, risks of adverse changes in
 general economic conditions, and in the healthcare industry specific risks
 associated with competition and competitive pricing pressures, and other risks
 detailed in the Company's filings with the Securities and Exchange Commission.
 
     Contact: Dr. Paul R. Sohmer, President & Chief Executive Officer, James D.
 Everhart, Director of Finance and Treasurer, or Kathryn E. Johnson, Manager of
 Corporate Communications and Investor Relations, all of TriPath Imaging, Inc.,
 336-222-9707
 
 SOURCE  TriPath Imaging, Inc.

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