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GermanFrequently asked questions
Below are answers (A) to frequently asked questions (Q) about the FEMTELLE uPA/PAI-1 test.
Which patients do benefit from the FEMTELLE assay?
When should the FEMTELLE test be performed?
How accurate are the test results?
Is the FEMTELLE test included in the guidelines?
How do the test results correlate with the risk of disease recurrence?
Does the FEMTELLE test provide information about chemotherapy benefit?
Can I perform the FEMTELLE test at my laboratory?
How do I order the FEMTELLE test?
Can I ship patient samples to another laboratory for testing?
Which centers do perform the FEMTELLE test?
What type of tumor tissue is required for the FEMTELLE test?
How much tumor tissue is required?
How are the results of the FEMTELLE test reported?
When can I expect the test results?
Q: What is FEMTELLE?
A: The FEMTELLE assay quantifies the risk of disease recurrence and predicts the likelihood of chemotherapy benefit in node negative breast cancer patients. The test provides information that may be used to enhance treatment planning. The test results can help to indicate if chemotherapy is, in fact necessary in node negative breast cancer patients.
The test has been recommended at the highest Level of Evidence (LOE-I) for therapy decisions in node-negative breast cancer by the AGO Guidelines of the German Working Group of Gynecological Oncology and the S3 Guidelines of the German Cancer Society. The US-American ASCO Guidelines also recommend the test since 2007.
Q: Which patients do benefit from the FEMTELLE assay?
A: The FEMTELLE Test is clinically validated for newly diagnosed breast cancer patients. Especially node-negative patients classified as an intermediate risk (G2 differentiation) benefit from the test results.
Q: When should the FEMTELLE test be performed?
A: The test can be performed directly after the primary surgery on either fresh or frozen tumor tissue samples. To this purpose a small representative tumor tissue sample (minimum 50 mg) has to be removed from the surgically resected tumor tissue. The tissue sample for the FEMTELLE test must not be fixed and has to be stored frozen until test performance. The test is intended for use in newly diagnosed patients with node-negative breast cancer.
Q: How accurate are the test results?
A: The FEMTELLE test was clinically validated in an independent prospective multicenter trial and a pooled metaanalysis (incuding more than 8000 patients). The results of the of the initial validation study were published in the Journal of National Cancer Institute (2001 (93) 913-20).
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Q: Is the FEMTELLE test included in the guidelines?
A: The US American ASCO (American Society of Clinical Oncology), the German Cancer Society as well as the German Working Group of Gynecological Oncology (AGO) have included the FEMTELLE test in their guidelines The test is recommended at the at the highest Level of Evidence (LOE-1) for therapy decisions in node-negative breast cancer. The test provides information that may help to determine whether patients with node-negative breast cancer will benefit from chemotherapy
(for further information see “Guidelines“).
Q: How do the test results correlate with the risk of disease recurrence?
A: The results of the FEMTELLE uPA/PAI-1 assay are reported as absolute protein concentrations of uPA (urokinase-type plasminogen activator) and PAI-1 (urokinase plasminogen inhibitor type-1) in the patient’s tumor tissue. The uPA and PAI-1 values are referred to the respective total protein concentrations. The respective results help to identify node-negative patients that are either at a high or low risk of disease recurrence after primary surgery.
Long term clinical trials confirmed the following cut off values:
uPA = 3 ng/mg total protein
PAI-1 = 14 ng/mg total protein
Patients with low uPA and low PAI-1 values (below the cut off) do have a low risk of disease recurrence.
Patients with high uPA and /or high PAI-1 values (above the cut off) do have an increased risk of disease recurrence.
Q: Does the FEMTELLE test provide information about chemotherapy benefit?
A: In addition to quantifying breast cancer recurrence risk the FEMTELLE test also provides information regarding chemotherapy benefit. Patients with either high uPA and / or PAI-1 values do benefit from adjuvant chemotherapy after surgery. The data about chemotherapy benefit has been published in Cancer Research 2002 (62) 4617-22.
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Q: Can I perform the FEMTELLE test at my laboratory?
A: In principle the test can be performed at any laboratory that has access to a tissue homogenizer, ELISA reader and cooled centrifuge (16.000 g). Until today more than 30 clinical centers and diagnostic laboratories have been performing the test in Germany, France, Slovenia and Spain.
If you are planning to perform the test at your laboratory please contact us directly. You will receive order information, and detailed information about the test and technical procedure.
For orders or more detailed information about the test please contact:
Dr. Claudia Olenik
American Diagnostica GmbH
email: c.olenik@amdiag.de
tel: +49 6157 803817
Q: How do I order the FEMTELLE test?
A: The FEMTELLE test can be ordered through American Diagnostica GmbH (Pfungstadt, Germany).
For orders or more detailed information about the test please contact:
Dr. Claudia Olenik
American Diagnostica GmbH
email: c.olenik@amdiag.de
tel: +49 6157 803817
If you have a local FEMTELLE distributor in your country we will give you the respective information.
Q: Can I ship patient samples to another laboratory for testing?
A: If your hospital does not perform the FEMTELLE test you can send your patient samples for uPA/PAI-1 determination to one of the centers that have been performing the test.
In Germany more than 100 hospitals and breast cancer centers offer the test to their breast cancer patients. Many of them send their patient samples for uPA/PAI-1 determination to one of the 22 centers in Germany that perform the test. Some of them offer courier services (including dry ice transport) for a convenient transport of your patient samples.
For more information please contact:
Dr. Claudia Olenik
American Diagnostica GmbH
email: c.olenik@amdiag.de
tel: +49 6157 803817
Q: Which clinical centers do perform the FEMTELLE test?
A: In Germany, France, Slovenia and Spain we do have more than 30 centers that perform the FEMTELLE test. Some of them offer courier services (including dry ice transport) for a convenient transport of your patient samples.
For more detailed information please contact:
Dr. Claudia Olenik
American Diagnostica GmbH
email: c.olenik@amdiag.de
tel: +49 6157 803817
Q: What type of tumor tissue is required for the FEMTELLE test?
A: For uPA/PAI-1 determination a minimum of 50 mg unfixed tumor tissue is required. Important: The tumor tissue must not be fixed. After removal of a representative piece of fresh (unfixed) tumor tissue it should be frozen and kept at -20 C until the test is performed.
Q: How much tumor tissue is required?
A: For uPA/PAI-1 determination 50 mg of unfixed tumor tissue is required.
Q: How are the results of the FEMTELLE test reported?
A: The results of the FEMTELLE uPA/PAI-1 assay are reported as absolute protein concentrations of uPA (urokinase-type plasminogen activator) and PAI-1 (urokinase plasminogen inhibitor type-1) in the patient’s tumor tissue. The uPA and PAI-1 values are referred to the respective total protein concentrations. The respective results help to identify node-negative patients that are either at a high or low risk of disease recurrence after primary surgery.
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Q: When can I expect the test results?
A: The FEMTELLE test results are typically available within 5 days from the date the laboratory received the tumor tissue sample.