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Cancer Prognosis

FEMTELLE® is intended for the quantitative measurement of human Urokinase-type Plasminogen Activator (uPA) and human Plasminogen Activator Inhibitor Type-1 (PAI-1) in detergent extracts of breast tumor tissue. uPA and PAI-1 are clinically validated independent prognostic markers in breast cancer and have reached the highest Level of Evidence (LoE-1) according to the “Tumor Marker Utility System”.

FEMTELLE™ uPA/PAI-1 ELISA REF: 899

CE Marked

Prospective, randomized multi-center clinical trials as well as retrospective meta-analyzes have shown that measurement of both uPA and PAI-1 levels in extracts of breast cancer tumor tissue can help to assess the risk of disease recurrence. FEMTELLE results are useful for the following indications:
1. Prognosis for breast cancer patients who are either at low or high risk for disease recurrence following surgery. A low level of both uPA and PAI-1, below the established cutoff value of 3 ng uPA/mg of total protein and 14 ng of PAI- 1/ mg total protein, places the patient in the low risk category for disease recurrence. A high level of uPA and/or PAI-1, above the respective cut-off values, correlate with a significantly shortened Disease Free Survival (DFS) and reduced Overall Survival (OS) as compared to patients with tumor tissue containing low levels.
2. Prediction: It has been proposed that uPA and PAI-1 levels may be used to predict patient response to adjuvant chemotherapy. Clinical trials suggest that breast cancer patients with low uPA and PAI-1 are unlikely to benefit from adjuvant chemotherapy, whereas those patients with high uPA and PAI-1 levels are more likely to benefit from adjuvant chemotherapy.

Results from FEMTELLE should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer disease


REAGENTS 
96Anti-human PAI-1 IgG coated microwells
96Anti-human uPA IgG coated microwells
6Vials of PAI-1 Standards, 0-10 ng/mL, lyophilized
6Vials of uPA Standards, 0-1.0 ng/mL, lyophilized
2Vials of Detection Antibody, biotinylated anti-human PAI-1, lyophilized
2Vials of Detection Antibody, biotinylated anti-human uPA, lyophilized
1Vial of PAI-1 Enzyme Conjugate, Streptavidin-Horseradish Peroxidase, 60 μL
1Vial of uPA Enzyme Conjugate, Streptavidin-Horseradish Peroxidase, 60 μL
2Vials of Enzyme Conjugate Diluent, 20 mL, lyophilized
2Vials of Substrate, TMB, 11 mL
2Vials of Detergent, 25% Triton X-100, 12 mL
2Packets of TBS Buffer, pH 9.6, powder
4Packets of PBS Buffer, pH 7.4, powder

SPECIFICATIONS 
SAMPLESDetergent extracts of tumor tissue
SAMPLE PREPARATION1:20 dilution in sample buffer
SAMPLE VOLUME100 μL of diluted sample
TOTAL ASSAY TIME2½ days, including detergent extraction
STANDARD RANGE PAI-10 – 10 ng/mL
LOWER LIMIT OF DETECTION, PAI-10.125 ng/mL
PRECISION, PAI-1Intra-assay CV = 6.7%
Inter-assay CV = 4.7%
STANDARD RANGE, UPA0 – 1.0 ng/mL
LOWER LIMIT OF DETECTION, UPA0.025 ng/mL
PRECISIONIntra-assay CV < 4.7%
Inter-assay CV < 3.9%
NUMBER OF TESTS96