Independent International Studies Confirm Clinical Advantages of The ThinPrep(R) Pap Test(TM)
PR Newswire - January 19, 2000 11:39
BOXBOROUGH, Mass., Jan. 19 /PRNewswire/ -- The ThinPrep(R) Pap Test(TM) significantly increased detection of precursors to cervical cancer and improved specimen quality compared to the conventional Pap smear, according to three recently published studies conducted in laboratories in Switzerland, Hong Kong, and Taiwan. The ThinPrep Pap Test is manufactured and marketed by Cytyc Corporation (Nasdaq: CYTC) of Boxborough, Massachusetts.
A study by Weintraub et al., published in the January issue of Diagnostic Cytopathology (2000;22:52-9), had three major conclusions: The ThinPrep Pap Test found more low-grade and high-grade precursors of cervical cancer, there was excellent correlation between the ThinPrep result and cervical biopsy, and the quality of the specimen was dramatically improved. The study, conducted in Geneva, Switzerland, under routine conditions in an outpatient setting was impressive in its size, comparing the results obtained from 39,864 ThinPrep Pap Tests to results from 130,381 conventional cytologic smears. The patients were from the general community who were being routinely screened by physicians in private practice for cervical cancer. Using a sophisticated odds-ratio statistical method in order to factor in various patient and clinician variables, the authors reported a statistically significant, 2.2-times-greater chance of having a positive diagnosis with the ThinPrep method compared to the conventional Pap smear. Biopsy follow-up confirmed a histological lesion in 93 percent of the ThinPrep Pap Tests reported as high-grade squamous intraepithelial lesions (HSIL). The study also reported a 25 percent reduction in the number of "unsatisfactory" specimens and a 71 percent reduction in the number of "satisfactory but limited by" (SBLB) specimens with the ThinPrep method. The authors noted that the ThinPrep method reduced the number of SBLB specimens due to an absence of endocervical component (ECC) by 50 percent.
A second study, published in the Hong Kong Medical Journal (1999;5:233-9), Yeoh et al., compared the results of 16,541 ThinPrep Pap Tests to 7,258 conventional Pap smears. The ThinPrep Pap Test results showed a statistically significant increase in the detection of low-grade and high-grade lesions compared to the conventional Pap smear. The authors also reported a statistically significant reduction in the frequency of "unsatisfactory" specimens and "satisfactory but limited" specimens as well as a reduction of borderline "atypical squamous cells of undetermined significance" reports. This study also found that the ThinPrep Pap Test yielded a significantly higher percentage of samples that contained endocervical cells compared with conventional smear specimens.
A third study, conducted at Mackay Memorial Hospital in Taiwan was recently published in the Journal of the Formosa Medical Association (1999;98:500-5). The split-sample study by Wang et al., included matched-pair slides, one conventional and one ThinPrep, from 972 patients. The conventional smear was made first and then the ThinPrep slide was prepared using only the residual material. The authors reported a statistically significant increase in the detection of low-grade and high-grade lesions. The study also noted that the detection rate of infectious agents was higher with the ThinPrep method. In addition, the ThinPrep method yielded significantly more satisfactory specimens.
"It is important to note that as adoption of the ThinPrep Pap Test expands globally to international laboratories from Europe to Asia, the results of independent clinical studies are relatively constant," said James Linder, M.D., Cytyc's medical director. "The ThinPrep Pap Test consistently demonstrates significantly improved detection of cervical cancer precursors, excellent biopsy correlation and improved specimen quality."
Cytyc Corporation develops, manufactures, and markets the ThinPrep(R) System for medical diagnostic applications. The ThinPrep System consists of the ThinPrep(R) 2000 Processor and related reagents, filters, and other supplies. Since introduction of the ThinPrep System, Cytyc has manufactured more than 1,000 ThinPrep 2000 Processors and 10 million ThinPrep(R) Pap Tests for cervical cancer screening.
Cytyc(R) and ThinPrep(R) are registered trademarks and ThinPrep(R) Pap Test(TM) is a trademark of Cytyc Corporation.
Forward-looking statements in this press release are made pursuant to the 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 management's plans and objectives for future operations, product plans and performance, potential savings to the healthcare system, management's assessment of market factors, as well as statements regarding 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 timely and adequate levels of third-party reimbursement, CPT code implementation delays and delays in reimbursement, risks associated with potential year 2000 software disruptions involving the products and systems of the Company and certain third party customers, suppliers, and payers, 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 healthcare industry specifically, risks associated with competition and competitive pricing pressures, potential liabilities and costs associated with litigation, and other risks detailed in the Company's filings with the Securities and Exchange Commission, including in its 1998 Form 10-K filed with the Commission.
SOURCE Cytyc Corporation
/CONTACT: Joseph Kelly, Chief Financial Officer, Anne Rivers, Investor
Relations, Jeff Keene, Healthcare Media, all of Cytyc Corporation,
978-266-3010; Robert P. Jones, Ephie Bernstein, Dory Lombardo, or Media:
Stacey Nield, all of Morgen-Walke Associates, 212-850-5600, for Cytyc; Lloyd
Benson or Shanti Nigam of Schwartz Communications, 781-684-0770/
Another good PR. Waiting for those upgrades.
Jack |
