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FDA Clears Way For Broader Use of ThinPrep(R) Pap Test(TM)

BOXBOROUGH, Mass., Feb. 26 /PRNewswire/ -- Cytyc Corporation's (Nasdaq: CYTC) Premarket Approval Application (PMA) Supplement was approved yesterday by the U.S. Food and Drug Administration (FDA) to allow use of a common Pap collection method, the endocervical brush and plastic spatula, with the ThinPrep(R) Pap Test(TM). This approval was based on study results of approximately 1,500 women in which the ThinPrep Pap Test, used with the endocervical brush and spatula collection method, identified more positive cases of cervical abnormality as compared to the conventional Pap smear prepared with the same collection device.

"Clinical studies of the ThinPrep Pap Test have proven that it provides earlier detection of cervical abnormalities than the conventional Pap smear," said Mary Corkill, M.D., laboratory director, Planned Parenthood of the Rocky Mountains, and principle investigator in the studies. "In fact, when used with the endocervical brush and spatula, the ThinPrep Pap Test identified 20 high-grade lesions compared to 13 high-grade lesions identified by the conventional Pap smear. This represents 7 cases of high-grade or more severe lesions that would have gone undetected by the conventional Pap smear."

"Recent studies have demonstrated that even with commonly used collection devices as many as 80 percent of the cervical cells may be discarded along with the device when using the conventional Pap smear method. However, with the ThinPrep Pap Test, virtually all cells are captured in the preservative solution, regardless of the collection device used," said James Linder, M.D., medical director, Cytyc Corporation. "This most recent study underscores the flexibility and efficacy of the ThinPrep Pap Test when used with a variety of cervical sampling devices."

With the conventional Pap smear, the physician manually smears cervical cells onto a microscope slide. With the ThinPrep Pap Test the physician collects the cervical cell sample in the traditional manner, but rather than smearing the cervical sample onto a slide, the collection device is rinsed in a vial of preservative solution. The patient specimen is then sent to a laboratory where the ThinPrep instrument disperses and filters the specimen to reduce blood, mucus and inflammation and applies a thin, even layer of the cervical cells to a microscope slide.

"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 more effective ThinPrep Pap Test as easy as possible for the practicing physician," said Patrick Sullivan, chief executive officer, Cytyc Corporation.

The Company's ThinPrep Pap Test for cervical cancer screening was approved by the FDA on May 20, 1996, as a replacement for the conventional Pap smear based upon data from a study that employed a commonly used sampling instrument known as a broom device. Yesterday's FDA approval provides physicians with a broader choice of cervical collection devices.

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 Corporation has marketed ThinPrep since 1991 for use in the diagnosis of cancers including lung, bladder and gastrointestinal tract and in the preparation of fine needle aspiration 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 provisions of the Private Securities Litigation Reform Act 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.

SOURCE Cytyc Corporation
 -0- 02/25/97

/CONTACT: Maryellen Royle, 215-928-2368, or Sandy Sherman, 215-928-2466, both of Dorland Sweeney Jones, for Cytyc Corporation/


CO: Cytyc Corporation; U.S. Food and Drug Administration ST: Massachusetts IN: MTC SU:

DP -- PHW011 -- 4035 02/26/97 07:54 EST
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Publication:PR Newswire
Date:Feb 26, 1997
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