Cytyc Corporation announces submission of PMA supplement to ThinPrep Pap Test - Company initiates direct marketing efforts to ob/gyn physicians and accelerates product development activities -.BOXBOROUGH, Mass.--(BUSINESS WIRE)--Aug. 8, 1996--Cytyc Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CYTC) announced today that it has submitted a Premarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. Application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement to the U. S. Food and Drug Administration (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. ) to allow use of the cytobrush/spatula collection method with Cytyc's ThinPrep System for 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. The Company's ThinPrep System for cervical cancer screening was approved by the FDA on May 20, 1996 as a replacement for the conventional Pap smear Pap smear or Papanicolaou smear Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S. based upon data submitted to the FDA by Cytyc. These data were from a study that employed a commonly used sampling instrument known as a broom device. Approval by the FDA of this recent supplement will provide physicians with an alternative to the broom when collecting cervical samples. The cytobrush/spatula is one of the most commonly used methods of collecting cells for cervical cancer screening. This PMA supplement is supported by clinical studies enrolling more than 1,500 women. These recent clinical studies demonstrated the use 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. with the cytobrush/spatula combination resulted in a 110% increase in the number of cases identified as positive compared to the use of the conventional Pap smear with the same collection device. Patrick J. Sullivan, President and Chief Executive Officer of Cytyc stated, "using the cytobrush/spatula collection method, the ThinPrep Pap Test identified 88 women as positive, while the conventionally prepared Pap smear identified 42 cases as positive, about the national average of 3% of women tested." According to the Company, the results of these most recent studies were consistent with the larger study completed last year and submitted to the FDA to support the Company's PMA and underscore the flexibility of the ThinPrep Pap Test when utilized with a variety of cervical sampling devices. Mr. Sullivan continued, "this supplement to our original PMA will facilitate conversion by physicians to the ThinPrep Pap Test by making our technology compatible with a variety of collection devices. We are committed to making the conversion from the conventional Pap smear to the ThinPrep Pap Test as easy as possible for the practicing physician." Cytyc also announced today that it intends to increase its previously budgeted expenditures in the fourth quarter in order to market the ThinPrep Pap Test to healthcare providers. Cytyc believes that this increase will build demand for use of the ThinPrep Pap Test by physicians and use of the ThinPrep System by clinical laboratories. In connection with the commercial launch of the ThinPrep Pap Test, Cytyc currently intends to increase expenditures in the fourth quarter directed towards increased marketing efforts to healthcare providers as well as expedited development of the next generation ThinPrep Processor. 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. Cytyc received clearance on May 20, 1996 to use the ThinPrep System as a replacement for the conventional Pap smear. Cytyc Corporation has marketed ThinPrep since 1991 for use in the diagnosis of cancers including lung, bladder and gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract and in the preparation of fine needle aspiration fine needle aspiration Diagnostics A method of in which a thin or “skinny”–18- to 23-gauge needle is used to suck in cells or tissue bits for diagnoses; the sites selected for FNAs are often guided by radiologists with fluoroscopy, CT, MRI of thyroid and breast. Cytyc's headquarters, research, development and manufacturing facilities are located in Boxborough, Mass. Securities and Exchange Commission Information: Forward-looking statements in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including, without limitation, risks associated with the Company's dependence on a single product, uncertainty of market acceptance, and limited number of customers, 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, and other risks detailed in the Company's filings with the Securities and Exchange Commission. CONTACT: Joe Kelly Chief Financial Officer (508) 266-3000 or Investor Relations Investor relations The process by which the corporation communicates with its investors. : Robert Jones/Evan Smith Media: Michelle Zawrotny Morgen-Walke Associates (212) 850-5600 |
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