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Nipple Aspirate Test Not a Replacement for Mammography

By MedImaging International staff writers
Posted on 06 Jan 2014
Image: The mammary aspiration specimen cytology test (MASCT) (Photo courtesy of Atossa Genetics).
Image: The mammary aspiration specimen cytology test (MASCT) (Photo courtesy of Atossa Genetics).
A US health administration is warning the public, including women and healthcare providers, that a nipple aspirate test should not be used as an alternative to mammography, other breast imaging modalities, or breast biopsy, and not be used by itself to screen for or detect breast cancer.

The US Food and Drug Administration (FDA; Silver Spring, MD, USA) is not aware of any valid scientific data to show that a nipple aspirate test alone is an effective screening tool for any medical disorder including the early detection of breast cancer or other breast disease.

The FDA, other public health agencies, and US medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages. These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the US National Cancer Institute, and the Society for Breast Imaging. The US National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical usefulness of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

A nipple aspirate device is a type of pump used to gather fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Certain manufactures are endorsing the use of nipple aspirate tests as a standalone assessment tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also assert that a nipple aspirate test can identify precancerous abnormalities and diagnose breast cancer before undergoing mammography with only a sample of a few cells. The FDA is alarmed that women will believe these deceptive claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

Possible health consequences include false-negative test results and false-positive test findings. False-negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death. False-positive findings may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

Recommendations for patients: (1) The FDA reported that patients should remember that a nipple aspirate test, such as Atossa Genetics, Inc.’s (Seattle, WA, USA) mammary aspiration specimen cytology test (MASCT) and/or ForeCYTE breast health test systems, or the HALO breast Pap test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis. (2) If an individual had a nipple aspirate test as a standalone evaluation tool for screening and diagnosing breast cancer, she should request a mammogram from her healthcare provider to get accurate findings. (3) Undergo regular mammograms according to screening guidelines or as recommended by the healthcare provider.

Recommendations for healthcare providers: (1) Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis. (2) The FDA has taken action against specific manufacturers promoting nipple aspirate tests as a stand-alone strategy for screening and diagnosing breast cancer.

In February 2013, the FDA sent a warning letter to Atossa Genetics, Inc. for the marketing and promotion of a nipple aspirate test for uses that had not received FDA marketing clearance or approval. In this warning letter, the FDA instructed the manufacturer to immediately stop making inappropriate statements about nipple aspirate tests.

In October 2013, Atossa Genetics, Inc. initiated a voluntary recall to remove the ForeCYTE breast health test and the Mammary aspiration specimen cytology test (MASCT) from the market. The FDA classified this recall as class I, which means that the product is dangerous or defective and has a reasonable chance of causing serious health problems or death.

The FDA will continue to monitor the promotional activity of nipple aspirate test manufacturers, and keep the public and practitioners informed as new information becomes available.

Related Links:

US Food and Drug Administration
Atossa Genetics


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83 (39.815902709961): SELECT show_live FROM jos_com_show_setting LIMIT 1
84 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1
85 (33.140182495117): SELECT show_live FROM jos_com_show_setting LIMIT 1
86 (!!!!! 1591.2055969238): SELECT show_live FROM jos_com_show_setting LIMIT 1
87 (181.91337585449): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
88 (150.91896057129): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
89 (590.80123901367): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (!!!!! 3106.1172485352): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (324.96452331543): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (579.1187286377): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (317.09671020508): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (50.067901611328): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (241.99485778809): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (167.1314239502): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (847.10121154785): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (46.014785766602): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (236.03439331055): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (452.99530029297): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (45.061111450195): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (!!!!! 3000.9746551514): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
105 (446.08116149902): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
106 (266.07513427734): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (982.99980163574): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (!!!!! 3915.0714874268): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
109 (288.00964355469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
110 (!!!!! 1181.8408966064): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (!!!!! 1134.8724365234): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (!!!!! 1024.0077972412): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (!!!!! 1362.8005981445): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (!!!!! 4559.0400695801): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
115 (!!!!! 3997.0874786377): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
116 (!!!!! 2211.0939025879): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
117 (!!!!! 8472.9194641113): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
118 (!!!!! 1874.9237060547): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
119 (446.79641723633): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
120 (!!!!! 1448.1544494629): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
121 (124.93133544922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
122 (279.90341186523): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 192801.95236206): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (!!!!! 10091.066360474): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294749997 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294749997 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (176.19132995605): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (51.021575927734): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (51.021575927734): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (41.961669921875): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (57.93571472168): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (43.869018554688): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (40.054321289062): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (!!!!! 2938.0321502686): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (67.949295043945): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (44.822692871094): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (494.00329589844): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (447.03483581543): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (59.843063354492): SELECT name FROM jos_deeppockets WHERE id=211
138 (161.88621520996): SELECT name FROM jos_deeppockets WHERE id=211
139 (870.94306945801): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (!!!!! 11063.098907471): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (!!!!! 3680.944442749): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
142 (96.08268737793): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
143 (!!!!! 28057.098388672): TRUNCATE TABLE jos_trademed_module
144 (190.01960754395): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (136.8522644043): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294749997 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (642.06123352051): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (83.92333984375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (119.92454528809): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
149 (83.92333984375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
150 (!!!!! 1590.0135040283): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (!!!!! 2501.9645690918): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
152 (!!!!! 1868.9632415771): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
153 (110.86463928223): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294749997 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294749997 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (947.95227050781): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=211 or channel_id is null)
155 (102.04315185547): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=211 or channel_id is null)
156 (!!!!! 1068.115234375): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (!!!!! 4043.8175201416): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
158 (!!!!! 2907.0377349854): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294749997 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294749997 AND published='1' LIMIT 1
159 (64.13459777832): select jos_twitters.link from jos_twitters where cat=10
160 (39.100646972656): select jos_facebook.link from jos_facebook where cat=10
161 (41.007995605469): select jos_google_plus.link from jos_google_plus where cat=10
162 (40.054321289062): select jos_linkedin.link from jos_linkedin where cat=10
163 (363.11149597168): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 6652.83203125): insert into jos_banners_delta values (14615,'2025-08-13 09:27:38','216.73.216.186','view'),(14202,'2025-08-13 09:27:38','216.73.216.186','view'),(14203,'2025-08-13 09:27:38','216.73.216.186','view')