Printer Friendly
The Free Library
19,607,053 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Eleven Studies Evaluating Cytyc's ThinPrep Imaging System Presented at National Scientific Meeting.


CHICAGO -- Cytyc Corporation (Nasdaq: CYTC) announced today that eleven studies evaluating the performance of the ThinPrep(R) Imaging System were presented this week at the 52nd Annual Scientific Meeting of the American Society of Cytopathology The creator of this article, or someone who has substantially contributed to it, may have a conflict of interest regarding its subject matter.
It may require cleanup to comply with Wikipedia's content policies, particularly neutral point of view.
 (ASC ASC Ambulatory surgery center, see there ) in Chicago. The studies reported on a range of implementation and performance criteria including validation protocols, disease detection and impact on workload.

Three of the studies presented were conducted at the Cleveland Clinical Foundation. A platform presentation by Dawn Underwood, C.T.(ASCP ASCP American Society of Clinical Pathologists. ), entitled, "Implementation of the ThinPrep Imaging System: Impact on Cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components.  Laboratory Workload, Turnaround Time (1) In batch processing, the time it takes to receive finished reports after submission of documents or files for processing. In an online environment, turnaround time is the same as response time.  and Quality Parameters," reported a significant reduction in turnaround time after implementing Image-Directed Cytology(TM), which the author noted may improve physician and patient satisfaction. A second study presented by Andrea Dawson, M.D., "ThinPrep Imager System (TIS) Performance in the Diagnosis of Uncommon Malignancies," reported that cytotechnologists using the TIS correctly diagnosed these abnormal cells particularly in glandular glandular /glan·du·lar/ (glan´du-ler)
1. pertaining to or of the nature of a gland.

2. glanular.


glan·du·lar
adj.
1.
 lesions. The third study, "Quality Control Re-Screening in an Era of Computer-Assisted Imaging: What Can We Learn?," by Susan Porter, M.D., and others, evaluated abnormalities identified on quality control rescreening to assess location (machine) vs. interpretation errors.

Two studies were conducted by M. Nasar Queshi, M.D., Ph.D., and others at Lakewood Pathology Associates in Lakewood, New Jersey. "Impact of the ThinPrep Imaging System on Detection Rates of Cervical Abnormalities," showed a statistically significant increase in the detection of LSIL LSIL Low-grade squamous intraepithelial lesion, see there  or higher (LSIL+) by cytotechnologists using the ThinPrep Imaging System compared to manual review. A second study, "Validation of the Accuracy of the ThinPrep Imaging System to Identify Abnormalities," concluded that cytotechnologists using the ThinPrep Imaging System correctly identified normal cases, allowing accurate identification of significant cellular abnormalities and organisms.

Fern S. Miller, M.S.M., C.T.(ASCP), and others at Metropolitan Pathologists in Denver, Colorado, completed two studies in which the ThinPrep Imaging System was compared to and validated against manual screening. "Comparison of Manual and Imaging-Directed Screening of the ThinPrep Pap Test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix.  in a Large Metropolitan Cytology Practice," reported a statistically significant increase in the rate of LSIL and HSIL HSIL High-grade squamous intraepithelial lesion, see there  detection by cytotechnologists using the ThinPrep Imaging System compared to manual screening. The validation study described the protocol when implementing the Imager at Metropolitan Pathologists Laboratory.

"The ThinPrep Imaging System in the Detection of High Grade Squamous Intraepithelial Lesions (HSIL) of the Uterine Cervix," a study conducted by Kathleen Richard, C.T.(ASCP), C.T.(IAC (1) (InterApplication Communications) The interprocess communications capability in the Macintosh starting with System 7.0. Many IAC events take place behind the scenes. ), of Mercy Medical Center in Springfield, Massachusetts, reported that "based on early evidence, it appears that Paps screened with the ThinPrep Imaging System detect a significantly higher number of HSIL than non-imaged manually screened ThinPrep Paps."

Jonathan Weintraub, M.D., of Laboratoire Weintraub in Geneva Geneva, canton and city, Switzerland
Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva.
, Switzerland, presented a study on the comparison of the ThinPrep Imaging System and manual screening in the detection of abnormal cervicovaginal cytology specimens. Results indicate improvements in standardization and productivity with the Imager do not appear to have a negative impact on sensitivity.

Another study conducted in Europe, "Validation of the ThinPrep Imaging System: A Multi-Center European Study," presented data showing that cytotechnologists using the ThinPrep Imaging System are more effective than Manual review for the detection of ASCUS as·cus
n. pl. as·ci
A membranous, often club-shaped structure in which typically eight spores are formed through sexual reproduction of ascomycetes.



ascus

pl. asci; the spore case of Ascomycetes.
 and more severe cervical abnormalities. The results are consistent with the U.S. based trial that led to FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval.

Finally, a study by Deanna Iverson, of Palo Alto Foundation, "Impact of the ThinPrep Imaging System on the Detection of Cervical Abnormalities," reported that detection rates for LSIL and more severe cases increased with cytotechnologist cy·to·tech·nol·o·gist
n.
A technician trained in medical examination and identification of cellular abnormalities.



cytotechnologist

a medical laboratory technologist specializing in cytology.
 use of the ThinPrep Imaging System compared to manual screening.

"It is outstanding to see that in many instances the performance of the ThinPrep Imaging System in routine laboratories exceeds the results we saw in our multi-site clinical trial," said James Linder, M.D., senior vice president and chief medical officer of Cytyc Corporation. "We hope that laboratories that have implemented this state-of-the-art technology will continue to evaluate its performance and present their findings to the medical community."

The ThinPrep Imaging System is the first fully integrated, interactive computer system that assists cytotechnologists and pathologists in the primary screening and diagnosis of ThinPrep Pap Test slides. The ThinPrep Imaging System combines revolutionary imaging technology with human interpretive expertise to improve cervical cancer Cervical Cancer Definition

Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
 screening efficiency and performance. The U.S. Food and Drug Administration approval of the ThinPrep Imaging System was based on clinical trial results that demonstrated an improvement in sensitivity for the detection of ASCUS+, an improvement in specificity for the detection of HSIL+ and a workload limit of 200 ThinPrep Imaging System assisted slides in no less than an 8-hour workday.

Cytyc Corporation is a leading medical device company that designs, develops, manufactures, and markets innovative and clinically effective products primarily focused on women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
. Cytyc products cover a range of women's health applications, including cervical cancer screening, breast cancer risk assessment, and treatment of excessive menstrual bleeding. The ThinPrep(R) System is the most widely used method for cervical cancer screening in the United States. The ThinPrep System consists of the ThinPrep(R) 2000 Processor, ThinPrep(R) 3000 Processor, ThinPrep(R) Imaging System, and related reagents, filters, and other supplies. The ThinPrep System also provides the platform from which the Company has launched its expansion into breast cancer risk assessment with the FirstCyte(R) Breast Test. Cytyc Surgical Products, a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 of Cytyc Corporation, manufactures and markets the NovaSure(R) Impedance Controlled Endometrial Ablation System, or the NovaSure(R) System, an innovative endometrial ablation device to treat menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea.

men·or·rha·gia
n.
See hypermenorrhea.
, or excessive menstrual bleeding.

Cytyc is traded on The Nasdaq Stock Market Nasdaq stock market

The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies.
 under the symbol CYTC. Cytyc, ThinPrep, FirstCyte, and NovaSure are registered trademarks 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 relating to the Company's financial condition, operating results and future economic performance, and management's expectations regarding future growth opportunities, product acceptance and business strategy, constitute forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from those statements. Risks and uncertainties include, among others, dependence on key personnel and proprietary technology, uncertainty of product development efforts and the success of investments in emerging technologies, product acceptance, management of growth, risks associated with litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 and the effective integration of acquired businesses and technologies, competition and competitive pricing pressures, risks associated with the FDA regulatory approval processes and any healthcare reimbursement policies, and other risks detailed in the Company's filings with the Securities and Exchange Commission, included under the heading "Certain Factors Which May Affect Future Results" in its 2003 Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q filed with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in Company expectations or events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Nov 16, 2004
Words:1224
Previous Article:Income Opportunity Reports 2004 Third Quarter Results.
Next Article:Schaeffer's Option Bytes Features Hewlett-Packard, Pixar Animation Studios, AutoZone, Rambus, and UnitedHealth Group.
Topics:



Related Articles
Advantages of ThinPrep Pap Test Presented At National Scientific Meeting.
Cytyc Receives FDA Approvable Letter for ThinPrep Imaging System.
More Than Forty Studies Evaluating Cytyc's ThinPrep System Presented at National Scientific Meeting.
Three Studies Evaluating Cytyc's NovaSure System Presented at ACOG Annual Meeting.
Cytyc Announces Multi-Year Agreement with LabCorp for ThinPrep Imaging System.
Five Studies Evaluating Cytyc's NovaSure System Presented at AAGL Meeting.
Twelve Studies Evaluating Cytyc's ThinPrep(R) Imaging System Presented at National Scientific Meeting.
Studies Presented at ASCCP Biennial Meeting Demonstrate Accuracy and Cost-Effectiveness of ThinPrep(R) Imaging System.
Twenty-One Studies Evaluating Cytyc's ThinPrep(R) Imaging System Featured at National Scientific Meeting.
Twelve Studies Evaluating Cytyc's MammoSite(R) Radiation Therapy System Presented at ASTRO Annual Meeting.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles