What testing services does the National Reference Laboratory for Breast Health provide?
The National Reference Laboratory for Breast Health provides a comprehensive set of breast health test evaluation services. From early detection and determination of a women’s baseline of breast health with the FDA-cleared, patented MASCT System for collection of nipple aspirated fluid, to more in depth review of milk duct fluid to pinpoint changes in breast health with the FDA-cleared, patented FullCYTE ductal lavage test, to genetic testing for early stage cancer patients to determine recurrence risk and to help guide personalized effective treatments with NextCYTE, to monitoring recurrence risk with fast and accurate information on circulating tumor cells with the ArgusCYTE test. The National Reference Laboratory for Breast Health provides innovative patented laboratory services and consulting that provide medical professionals the guidance they need to provide effective treatments to help prevent breast cancer and to restore breast health based on targeted, accurate, personalized information.
Why should I use the National Reference Laboratory for Breast Health rather than another laboratory?
The National Reference Laboratory for Breast Health utilizes recent advances in cancer genomics, family history, genetic and objective test results using traditional cytopathology and molecular subtyping to provide physicians and women actionable information on all aspects of breast health and disease. Our CLIA-certified lab focuses on breast health screening and diagnostics, providing cytopathology, biomarker, and genetic analysis to guide personalized intervention and treatment. Our board-certified, expert pathologists provide consulting and identify pre-cancerous and cancerous conditions in specimens such as nipple aspirate fluid and dutal lavage up to 8 years before they can be detected by other testing methods such as mammography, blood tests, ultrasound or MRIs, and can provide genomic testing to help improve the effectiveness of treatment in women who have early-stage cancer. Through best-in-class equipment, proprietary, FDA-cleared, patented medical device based procedures, and sophisticated laboratory developed tests, the National Reference Laboratory for Breast Health works closely with healthcare professionals to provide accurate and comprehensive evaluations to help prevent breast cancer and to restore breast health.
Is the National Reference Laboratory for Breast Health CLIA certified?
Yes, the laboratory received CLIA registration in March 2012, recognizing our professionalism and adherence to standards. Our Certificate of Registration number is 50D2024381 from the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendment (CLIA). We also hold state medical licenses from California, Florida, Maryland, Rhode Island, and Washington.
What makes the Atossa Genetics approach to breast health evaluation comprehensive?
From risk assessment, to high risk screening, genetic profiling, and ongoing recurrence monitoring of circulating tumor cells, the National Reference Laboratory for Breast health evaluates the full spectrum of breast health and disease. The National Reference Laboratory for Breast Health provides accurate, proprietary and highly insightful test results that help women and their caregivers monitor and improve breast health.
If I am a new customer, how do I get started?
Please see the Getting Started information or call us at 206.420.5561 or 800.351.3902.
Who can I talk to about test results?
The expert board-certified pathologists at the National Reference Laboratory of Breast Health will consult with you to interpret test results and to confer with you on the implications of the findings. Pathologists are available 8 am to 5pm Pacific time by calling 206.420.5561 or 800.351.3902 or by e-mailing email@example.com. Due to confidentiality and privacy regulations, please refer to the test request form number in all correspondence, including e-mail.
The National Reference Laboratory for Breast Health complies with all HIPAA requirements, and provides the highest level of confidentiality.
Does insurance pay for all of the tests performed by the National Reference Laboratory for Breast Health?
All of the test reports are completed and signed by licensed pathologists. Insurance coverage is based on cytology and immunohistochemistry (IHC) procedures that are standards of care in pathology. For information on your specific coverage, please contact your insurance company and verify their coverage or call 1-888-403-2685 to contact our billing department.
The National Reference Laboratory for Breast Health provides a personalized view of individual breast health and risk profile to empower women to make life style and treatment decisions that will be most effective. Diet and exercise impact breast health prognosis. By maintaining a healthy weight, reducing alcohol consumption, quitting smoking and exercising regularly, women can significantly improve their breast health. For more information please visit http://www.dslrf.org/breastcancer/content.asp?L2=1&L3=7&SID=412.
Test Submission / Sample Information
Can the National Reference Laboratory for Breast Health receive samples from central labs, CRO's, or other clinical sites?
Depending on the desired test and as long as the samples are obtained using the appropriate Atossa Genetics specimen collection kits, specimens can be collected from any clinical setting. For information on ordering specimen collection kits, please call our customer support number 206.420.5561 or 800.351.3902 and ask to speak with a customer service representative.
Does the National Reference Laboratory for Breast Health provide specimen collection kits to clinical sites for sample collection?
Yes. To register as a new customer and to order specimen collection test kits, please call our customer support number 206.420.5561 or 800.351.3902 and ask to speak with a customer service representative.
What are the sample volume and type requirements?
Please refer to the specimen section for the test you are interested in. Currently available: ForeCYTE Breast Health Test and ArgusCYTE Breast Health Test. Upcoming: FullCYTE and NextCYTE.
What is the standard turnaround time for receiving results?
Depending on the test ordered, our standard analytic time is two days, with the maximum laboratory time of seven days.
How are test results communicated?
Our expert board-certified pathologists provide detailed test reports that are mailed and delivered electronically to the submitting healthcare professional, you can use whichever is your organizations preference.
Can samples be tested if my volume does not meet the standard volume requirements?
The National Reference Laboratory for Breast Health uses nanotechnology and other sophisticated, patented technologies to evaluate extremely small test samples. Please refer to the specimen section for your test of interest for sample size requirements. Based on clinical trials, more than 99% of women receiving the ForeCYTE test produce useful samples of nipple aspirate fluid for evaluation.
What is the minimum number of samples that can be sent?
There is no minimum number of specimens that can be submitted to the National Reference Laboratory for Breast Health.
How should samples be shipped to the National Reference Laboratory of Breast Health?
Each specimen collection kit includes shipping instructions and pre-paid shipping packaging. To order a specimen collection kit please call us at: 206.420.5561 or 800.351.3902 or e-mail firstname.lastname@example.org. To obtain sample requirements, please see the Specimen tab for your test of interest.
In what way is the ForeCYTE test similar to a pap-smear test?
Analogous to a pap smear for breast health, the ForeCYTE test of Nipple Aspirate Fluid includes clinically proven, patented technology for early cancer detection and breast health evaluation. It detects changes to breast cells due to inflammation or infection, which can be precursors to cancer, as well as cellular changes that indicate the presence of malignant cells. This test can detect changes to breast health up to 8 to 10 years before they can be detected with other cancer screening technology such as mammography, so that a woman can take steps to stop breast cancer before it starts. The ForeCYTE test gives women the information they need to effectively prevent or treat breast cancer by providing a clear view of the health of the breast at both the cellular and genetic levels.
What percent of women produce useful samples for the ForeCYTE test?
Based on specimens collected under routine conditions, more than 99% of women receiving the ForeCYTE test produce useful specimens of nipple aspirate fluid for evaluation using the Atossa Genetics MASCT System and FDA-cleared MASCT device.
Why test for precancerous conditions?
With the advanced information provided by the ForeCYTE test, it is possible to treat and even reverse breast disease before it ever develops into breast cancer. As with any disease, prevention of breast cancer is more effective than treatment of breast cancer and leads to better health outcomes and lower healthcare costs. The ForeCYTE test can provide important baseline information for monitoring both breast health and the impact of pro-active steps women can take to treat pre-cancerous conditions.
Who should receive a ForeCYTE test of Nipple Aspirate Fluid?
Nipple aspirate fluid testing can be an effective risk assessment tool for non-lactating women ages 18 to 73 and should be considered part of routine annual health exams to monitor ongoing breast health.
Is the ForeCYTE test painful?
The ForeCYTE test evaluates nipple aspirate fluid, collected with our patented, FDA-cleared Mammary Aspirate Specimen Cytology Test (MASCT) collection device, which is similar to a hand held breast milk pump. Considered a non-invasive biopsy procedure, women report little to mild discomfort with the collection process.
Should my patients continue receiving mammograms in addition to ForeCYTE testing?
Yes, the ForeCYTE nipple aspirate fluid testing is considered a complementary procedure to mammography. It is proven to detect pre-cancerous changes in breast health up to 8 years before they can be identified by mammography. Mammography, on the other hand is currently recognized as the best way to identify breast cancer. The two tests can work well together, providing a full spectrum of breast health information. ForeCYTE is an especially important breast health test for women in the 18 to 49 year old age group for whom mammography is not typically recommended or women in which atypical lesions are smaller than 1mm and not easily detectable by mammography alone.
What changes in breast cells does the ForeCYTE Breast Health Test detect?
The ForeCYTE test integrates genetic, personal reproductive history, and family history with traditional cytology and patented molecular subtyping. The test uses five proteomic molecular markers of hyperplasia to identify women at increased risk of breast cancer by distinguishing between normal cells, flat epithelial or atypical hyperplasia cells, and cancer cells.
The test can identify the full range of breast cell conditions from normal to suspicious for cancer. Breast cells may be inflamed or infected, due to a variety of environmental or health conditions or they can indicate more advanced stages of breast disease.
The ForeCYTE test reveals cells that are classified as atypical or hyperplastic, providing insight into the type of breast disease that is present, and provides genetic information that guides personalized treatments based on an individualâ€™s profile for responsiveness to different treatment options.
|Category 0||Negative for atypical or malignant||No or <10 ductal cells. Foam cells.|
|Category I||Benign – normal ductal epithelial cells identified||Ductal cells. Foam cells. Apocrine cells|
|Category II||Benign – hyperplastic ductal epithelial cells identified||Cell distribution predominately in cohesive groups with > 10-50 cells. Minimal nuclear changes. Fine chromatin.|
|Category III||Atypical||Distinct nuclear enlargement, increasing N/C ration, irregular nuclear borders and nuclear variation. Course chromatin. Prominent chromocenters.|
|Category IV||Suspicious for malignancy||Single cells and groups of cells with nuclear features suspicious for cancer.|
What is a population risk, and why is it part of a ForeCYTE test report?
We report on population risk as well as individual risk over the next 10 years and the lifetime risk to provide context for an individual woman’s breast health. The population risk can be considered a baseline of breast health for a given population within a given age group. Comparing an individual to the population average helps illustrate the potential impact of making breast health lifestyle improvements and puts personal risk factors into perspective. We recommend that women receive the ForeCYTE test every one to two years as part of routine gynecological care for ongoing breast health risk assessment.
Why is testing the milk ducts important?
Over 95% breast cancer begins inside the milk ducts. Women who test positive for breast tissue abnormality using the ForeCYTE test, or those who have tested positive on a breast biopsy, have a family history indicating elevated cancer risks, or have had a mammogram that show microcalcifications (tiny calcium deposits) are candidates for milk duct testing. Atossa Genetics offers FullCYTE, a patented laboratory test for analyzing milk duct samples obtained through a procedure called ductal lavage.
What is ductal lavage, and what insights do the test results provide?
Ductal lavage is the process of extracting cells from the entire milk duct. The FullCYTE test examines 3-5 milk ducts per breast. Cells from the milk ducts provide a comprehensive picture of breast health. Normal cells register as healthy and normal. Cells that show changes are categorized as atypia, atypical hyperplasia or ductal carcinoma.
Atypia indicates the presence of cells that look different from normal cells, but that don’t have all the features of cancer cells.
Atypical hyperplasia indicates the presence of an elevated number of cells, and the fact that the cells look different from normal cells.
Ductal Carcinoma In Situ (DCIS) means there are cancerous cells present but they have not invaded areas outside of the breast duct. Because no invasion has occurred, DCIS is referred to as a precancer.
What sort of genomic testing does National Reference Laboratory for Breast Health perform?
NextCYTE is a genomic profiling and prognosis test that helps women identify their risk of cancer recurrence. Other Atossa Genetics tests include molecular biomarker evaluations to determine biological and cellular changes in the stages of cancer development to optimize efficacy of treatment options and recommendations.
How does the NextCYTE test compare to other genetic tests?
The National Reference Laboratory for Breast Health examines gene expression profiles that are directly related to breast health, using samples collected with the NextCYTE specimen collection kit, providing a thorough and detailed examination of risk factors to inform effective personalized treatment options to restore breast heath.
Why is it important to monitor breast health for women who have already undergone treatment for cancer?
Ongoing monitoring is an important step in improving a woman’s survival rate according to clinical studies. Finding and evaluating circulating tumor cells provides an early warning, and helps women receive effective treatment before they develop more advanced cancer.
How are circulating tumor cell test results interpreted and used by health professionals?
The ArgusCYTE test is highly sensitive, and can give healthcare providers and their patients early warning of metastatic breast cancer, at a point when it can be most readily treated, along with genomic information that informs the selection of treatment options for maximum effectiveness. Used for recurrence monitoring and whenever there is a treatment decision to be made, the ArgusCYTE test identifies estrogen receptors (ER) progesterone receptors (PR), and HR-2 information to help guide treatment selection.
How does ArgusCYTE testing differ from more traditional computed tomography (CT), testing?
ArgusCYTE can be done as soon as a woman completes her first cycle of therapy, while CT scanning cannot typically be performed until 12 weeks into therapy. The earlier information provided by ArgusCYTE allows the patient and her healthcare provider to make informed care decisions earlier in the treatment process. Clinical studies have shown that detection of these circulating tumor cells can predict disease progression and survival in patients with metastatic breast cancer.
How often should a woman have the ArgusCYTE test?
The ArgusCYTE test detects circulating tumor cells and can be done whenever there is a treatment decision to be made including immediately after breast cancer treatment begins, or at the time of the original biopsy or surgery. The ArgusCYTE test helps inform women and their healthcare professionals of the presence or absence of circulating tumor cells to guide selection of the best treatment and can be added to the annual visit for breast cancer survivors.
It is not the intention of the National Reference Laboratory for Breast Health to provide specific medical advice to users of its website, but rather to provide users with information to help them better understand the current range of approaches related to breast cancer prevention and treatment. The National Reference Laboratory for Breast Health urges users to consult with a qualified physician for answers to their personal medical questions.back to top of page >