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Nastech Submits Premarket Notification 510 (k) to FDA For Breast Disease Cytology Test Device.

Fifteen Minute Proprietary Test Intended as an Adjunct to Mammography And

Physical Examination in Diagnosis of Breast Cancer

HAUPPAUGE, N.Y., July 10 /PRNewswire/ --

Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today that it has filed a premarket notification 510 (k) application with the U.S. Food and Drug Administration (FDA) for marketing clearance of its Mammary Aspiration Specimen Cytology Test (MASCT) device. The MASCT is a non-invasive, non-powered device that draws Nipple Aspirate Fluid (NAF) from the breast for cytological examination.

The device is being developed as an adjunct to current standards of medical care, which include mammography and clinical breast exams, and arises from the Company's acquisition of Atossa HealthCare ("Atossa") in August 2000.

According to the American Cancer Society (ACS), breast cancer is the most common form of cancer among women, excluding non-melanoma skin cancers, and a leading cause of cancer deaths among women in the United States. Over 85 million American women ages 20 and over are candidates for breast cancer screening. ACS and the National Comprehensive Cancer Network currently recommend annual mammograms for women identified as normal risk beginning at age 40 and for women identified as high-risk beginning at age 25.

Market research indicates that a cellular-based Mammary Aspiration Specimen (MAS) test may have more value than an imaging approach, particularly as a screening option for women ages 20 and over, in the early detection of breast cancer. It is anticipated that most women in this age category may seek the MAS cytology test at the same time as a PAP smear test.

The Company anticipates that its proprietary device, as an adjunct to current therapy, will not replace mammography as a breast cancer-screening tool, but allow physicians to enhance breast cancer testing compliance among patients at lower cost. The Company is seeking a collaborative partner to market the device to patients and physicians and perhaps garner further revenues from cytology laboratory fees that are generated in processing the specimens generated.

"We believe that the MASCT device has significant potential commercial value and provides low-cost testing for patients and physicians for the identification of early cytological abnormalities that may warrant further diagnostic work-up," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. "The recent filing of the 510 (k) application is ahead of our original schedule and accelerates our need for a marketing collaboration with a major pharmaceutical company that has a global presence in women's healthcare. Because this product is outside of Nastech's focus on Formulation Science, any collaboration will be structured to require a minimum of Nastech resources for its execution and will be intended as an important financing source for the Company's core goals and objectives."

Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using "Formulation Science," a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety, and provide new therapeutic options. Additional information on Nastech is available at

Nastech Safe Harbor Statement

Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company's ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company's research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K.

Contact: Matthew D. Haines

Director, Corporate Communications

(631) 273-0101 ext. 329

Noonan/Russo Communications

(212) 696-4455

Ellie Kline, ext. 254 (media)

David Walsey, ext. 230 (investors)

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Publication:PR Newswire
Date:Jul 10, 2001
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