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Published Studies Show ThinPrep(R) Pap Test(TM) Improves Detection Of High- Grade Cervical Abnormalities

BOXBOROUGH, Mass., Jan. 27 /PRNewswire/ -- Three separate studies demonstrating the clinical advantages of Cytyc Corporation's (Nasdaq: CYTC) ThinPrep(R) Pap Test(TM) were published in peer-reviewed journals this month. Two of the studies were independent evaluations of the ThinPrep Pap Test in routine daily use. The third study reports results of a 1996 FDA trial on the
use of alternative sampling devices. All three studies found a marked increase in the detection of high-grade squamous intraepithelial lesions using the ThinPrep Pap Test compared to the conventional Pap smear.

The two independent studies of the ThinPrep Pap Test in routine clinical use were published in the January-February issue of Acta Cytologica, the official journal of the American Society of Cytopathology. Papillo et al. compared the results of over 8,000 ThinPrep Pap Tests collected over a seven month period during 1997 with conventional Pap smears collected from the same patient population during 1996. The study reported a 55 percent increase in the detection of high-grade cervical lesions with the ThinPrep Pap Test and an 88 percent increase in the detection of low-grade lesions. The increase was statistically, highly significant. The ThinPrep Pap Test also reduced the percentage of ambiguous or borderline cases diagnosed as ASCUS/AGUS by 27 percent. The study further found that the proportion of samples that were unsatisfactory or "limited by" was reduced by 32 percent with the ThinPrep method when compared to the historical conventional Pap smear control group.

In the second study, Bolick et al. compared the diagnostic results of over 10,000 ThinPrep Pap Tests with nearly 40,000 conventional Pap smears processed during the same time period at a large Utah laboratory. Dr. Bolick's study found that ThinPrep Pap Test yielded statistically significant higher proportions of both high-grade and low-grade cervical lesions. The increase was greater than two-fold. Specimen adequacy was also improved in the ThinPrep Pap Test group, which reduced the "satisfactory but limited by" (SBLB) rate by 35 percent and the unsatisfactory rate by 73 percent. The study is also published in the January-February issue of Acta Cytologica.

"These studies fully affirm earlier FDA trials that led to approval of the ThinPrep Pap Test as a replacement for the conventional Pap smear," said James Linder, M.D., Cytyc's Medical Director. "The reports are valuable because they show improved detection of the most important cervical abnormalities using the ThinPrep Pap Test in independent, routine laboratory settings."

The third study, by Corkill et al., was published in the January issue of the Journal of Lower Genital Tract Disease, the official journal of the American Society for Colposcopy and Cervical Pathology. The study, which included over 1500 patients, was conducted to assess the efficacy of the combination endocervical brush and spatula sampling method when used with the ThinPrep Pap Test. In each case a single cervical sample was taken from the patient, a conventional smear was made first and then only the remaining material was used for the ThinPrep Pap Test. Though the protocol was biased against it, the ThinPrep method yielded a 110 percent increase in low-grade lesions and 54 percent increase in high-grade lesions.

O'Leary et al., in a recent article published in JAMA, noted that while the clinical value of ASCUS detection has not been established, the importance of detection of high-grade and low-grade lesions is unquestioned. The authors also suggested that overcoming sampling and preparation problems with conventional Pap smears may be a cost-effective approach to reducing false negative diagnoses.

Dr. Linder concluded, "ThinPrep achieves increased diagnostic performance by improving sample representation and preparation."

Cytyc Corporation develops, manufactures, and markets the ThinPrep System for medical diagnostic applications. The ThinPrep System consists of the ThinPrep 2000 Processor and related reagents, filters, and other supplies. Currently nearly 400 laboratories in the United States utilize the ThinPrep 2000 for use in the diagnosis of cancers including cancers of the cervix, lung, bladder, and gastrointestinal tract and in preparation of fine needle aspiration of thyroid and breast.

Cytyc(R) and ThinPrep(R) are registered trademarks and ThinPrep Pap Test(TM) is a trademark of Cytyc Corporation.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding potential product benefits, management's plans and objectives for future operations, product plans and performance, potential savings to the health care system, management's assessment of market factors, as well as statements the strategy and plans of the Company, constitute forward-looking statements which involve risks and uncertainties, including, without limitation, risks associated with the Company's dependence on a single product, uncertainty of market acceptance and additional cost, dependence on third-party reimbursement, limited marketing and sales experience, and limited number of customers and lengthy sales cycle, as well as risks of downturns in economic conditions generally, and in the health care industry specifically, risks associated with competition and competitive pricing pressures, potential liabilities and costs associated with existing or future litigation, and other risks detailed in the Company's filings with the Securities and Exchange Commission in its 1996 Form 10-K and in its Form 10Q for the quarter ended September 30, 1997, filed with the Commission.

SOURCE Cytyc Corporation
 -0- 1/27/98

/CONTACT: Joseph Kelly, Chief Financial Officer, or Anne Rivers, Investor Relations of Cytyc Corporation, 978-266-3010; or Robert Jones, Meredith Pudalov, or Media: David Sassoon, all of Morgen-Walke Associates, 212-850-5600; or Healthcare Media: Jim Fox of Cooney Waters Group, 212-886-2200/


CO: Cytyc Corporation ST: Massachusetts IN: MTC SU:

DC -- NYTU113 -- 6425 01/27/98 11:29 EST
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Publication:PR Newswire
Date:Jan 27, 1998
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