new breast cancer screening - 1256898

rusalka59
Posts:2

What is your opinion of this new method of breast cancer screening:

Forecyte Breast Health Test

Help your patients rule out breast cancer at their annual gynecologic exam. Analogous to a pap test for breast health, the ForeCYTE Breast Health Test evaluates the health of breast ducts, lobules, and the terminal lobular ductal unit (TLDU) by analyzing the exfoliated cells in nipple aspirate fluid. The ForeCYTE test can provide vital early-detection of cancerous or pre-cancerous conditions years before they can be detected by other means. Clinically proven and and peer reviewed, the ForeCYTE test provides women aged 18 to 73 objective and actionable information to improve their breast health, using the FDA-cleared MASCT System device to collect a breast duct specimen.

The National Reference Laboratory for Breast Health is the leader in Nipple Aspirate Fluid testing. We provide comprehensive test results for Nipple Aspirate Fluid collected with the patented, FDA-cleared Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) system. Insightful ForeCYTE Breast Health Test lab reports integrate genetic and family history using traditional cytology and patented molecular sub-typing. We evaluate fluid samples from each breast separately; examining five proteomic biomarkers of hyperplasia and one biomarker of sample integrity for early risk assessment.

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Reply # - May 31, 2013, 11:37 AM

catdander
Posts:

Hi rusalka59, I'll ask our breast cancer specialist to comment on your question. It seems the explanation was pasted from another source, would you provide it just in case this is info she isn't familiar with.

I'm always happy to see something new and helpful.

Janine
forum moderator

Reply # - May 31, 2013, 04:25 PM

Dr West
Posts: 4735

To clarify, there are a lot of tests put forth as potentially beneficial, but they need to be carefully tested in a large setting that proves a survival benefit for screened patients before it becomes a standard of care. This test is being marketed without evidence that shows it actually improves outcomes.

-Dr. West

Reply # - May 31, 2013, 04:49 PM

rusalka59
Posts: 2

Thank you for your response. It does seem that research demonstrating improved outcomes would be a plus. It does seem unfortunate that it's a new test and the research is not available yet.

However, it's still difficult for me to see what would be harmful about early detection using this methodology as a screening since mammography is not able to detect cancer or pre-cancer at such early stages. I welcome your comments.

Here are more links about the test:

http://www.king5.com/health/Seattle-company-develops-new-test-to-detect…

1. www.nrlbh.com/testing-services/risk-assessment.php‎

http://finance.yahoo.com/news/atossa-genetics-exhibit-forecyte-breast-1…

Thank you,
rusalka59

Reply # - May 31, 2013, 05:00 PM

Dr West
Posts: 4735

The risk is that this test only claims to detect a precancerous condition. Screening may just tell people they are at higher risk but not change that. Also, much breast cancer is really very minimally threatening and heavily over-treated. If much of the abnormal/positive testing turns out to either not be cancer or be a cancer so non-threatening that it would have a <3% chance of shortening survival, the screening may lead to extra effort, cost, additional testing, and a lot of anxiety that wouldn't translate to any benefit in the tested population.

-Dr. West

Reply # - May 31, 2013, 05:10 PM

dr cianfrocca
Posts: 49

I agree with all of Dr West's comments. The risk is that an inadequately validated test will lead to unnecessary procedures that have very real risks. Say for example conventional imaging is negative but this test is positive. How do you act on that? More frequent imaging? On addition to the expense, that causes significant anxiety. In the worst scenario a woman might decide to have surgery she doesn't need. Because of all these risks a screening test needs to be well validated in large, prospective trials before being used.
Dr Cianfrocca

Reply # - September 13, 2013, 11:46 PM

delilahjones
Posts: 1

I have a real fear of what is going on with this highly marketed and insufficiently tested ForeCYTE breast health test and MASCT System. There are no clinical validations for the test, and no tests done on the product by a third-party. However, Atossa Genetics continues to market this test to physicians and women alike without worrying about the consequences. How do we know that there are not women who were given a "clean bill of health" with this test, showing that they would have a very low lifetime risk of cancer and that those women, in actuality, could have had stage IV cancer. Because as some of you may know, achieving ductal fluid from the breast is such a fickle procedure, if any duct was blocked for some reason or another (such as a tumor or growth) then the NAF would not even be collected from that duct. So what you would see is a clean result rather than the alarming truth. The inverse can also happen, of course, where some stray transient ADH cells could cause a woman to seek out chemo-preventive alternatives.

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