TEST : Endopredict
OTHER TEST REQUEST NAME : Not applicable
TEST COMPOSITION : Twelve Genes are measured:
1. Eight disease-relevant genes :
• BIRC5
• UBE2C
• DHCR7
• RBBP8
• IL6ST
• AZGP1
• MGP
• STC2

2. Three RNA normalization genes :
• CALM2
• OAZ1
• RPL37A

3. One DNA reference gene :
• HBB
INTENDED USE : • Used for determining the prognosis of breast cancer patients.
• EndoPredict is a multi-gene test for breast cancer patients. It determines whether a patient needs chemotherapy, or whether solely anti-hormonal therapy constitutes sufficient treatment.
METHODOLOGY : Polymerase Chain Reaction (PCR)
LABORATORY SECTION : Special Test
SPECIAL INSTRUCTIONS/PATIENT PREPARATIONS : • EndoPredict is only appropriate for patients with estrogen-receptor (ER) positive and HER2/Neu-negative breast cancer
• Patient should submit their slides and blocks with corresponding Medical Abstract.To avoid delay in processing of specimen, the following documentations must be completed:
• EndoPredict Test Request Form to be completely filled up the Ordering Physician
• Patient Consent Form to be signed by Patient or Legal Representative and Physician
• Pathology Report
COLLECTION/SAMPLE CONTAINER : Endopredict Kit to be provided by HPD
SPECIMEN AND VOLUME REQUIREMENT
Note: Follow tube manufacturer recommendation.
: • Specimen may be submitted in:
1. 1.5mL transparent microfuge tube/ tube
2. Tumor Block – 2 blocks required
3. Tumor Slides – 5 – 7 slides required

• Tumor Slides – 5 – 7 slides required
• The portion of the tumor should be at least 30% which represents the ratio of invasive tumor tissue to total tissue area (adipose tissue is not to be taken into account as tissue)
• A minimum of 10 mm of tumor is required (a single section or multiple equally to a 10 mm section)

• The portion of the tumor should be determined using the adjacent H&E (Hematoxylin and Eosin unstained) section
• Refer to Test Submission Guide for EndoPredict for detailed information
ALTERNATIVE SPECIMEN AND VOLUME REQUIREMENT : Not Applicable
SPECIMEN STABILITY    
•   ROOM TEMPERATURE (15-25°C) : Indefinite
•   REFRIGERATED TEMPERATURE (2-8°C) : Not applicable
•   FREEZER TEMPERATURE (-20°C) : Not applicable
TRANSPORT TEMPERATURE : • Microscope slides should be placed in slide holders or mailers and should be adequately padded before placing in a shipping/packaging container to prevent breakage.
• FFPE tissue blocks must be placed in a box and avoid direct sunlight to prevent melting and disorientation during transport or shipping.
• Transport specimen at 15°C ~25 °C (room temperature)
REJECTION CRITERIA : • Portion of the tumor is less than 30%
• Tumor size is less than 10mm
• Unlabelled sample
• If tumor slide is baked or adhesive is used
RUNNING DAY : Monday to Friday
CUT OFF TIME : 11:00 AM
TAT/RELEASING OF RESULTS : 24 working days (excluding Saturdays, Sundays and Holidays)
REFERENCE INTERVAL/RESULT INTERPRETATION : Not Applicable
LIMITATIONS/INTERFERENCES : None specified
FREQUENTLY ASKED QUESTIONS (FAQS) : Q: Who is eligible for EndoPredict ?
A: EndoPredict can be used for patients with newly diagnosed breast cancer. The tumor must be hormone receptor-positive and Her2/neu-negative. The test is suitable when no lymph nodes are infiltrated, as well as with up to three positive lymph nodes.

Q: What does Endopredict do?
A: EndoPredict is a risk assessment test which gives two types of result= HIGH RISK or LOW RISK. If a patient is said to be HIGH RISK, the accepted form of treatment is Chemotherapy. If a patient is said to be LOW RISK- the doctor may suggest other hormonal therapies that the patient can undergo instead of subjecting her to Chemotherapy. So a patient can be spared from undergoing chemotherapy. Not just save money from chemotherapy treatments but also spare her from the mental and emotional trauma.

Q: When is EndoPredict used?
A: EndoPredict can be used as soon as a tissue sample of the invasive tumour is available. The sample can be taken either by core needle biopsy or during surgery. The test will be used to provide additional decision support as to whether chemotherapy is necessary or not.

Q: How much tumour material is needed for testing? Sample type:
A: Only one section (tumour content 30 %) of a tissue block is needed. The tumour resection or needle biopsy must be fixed in neutral buffer/10 % formalin and embedded in paraffin. A 10µm section of resected tissue will suffice, provided that it exhibits at least 30% of the tumour. A 10µm section will also suffice for a needle biopsy in most cases; the yield is generally less than that of resected tissue. Therefore, a second section of a needle biopsy might be needed in some cases. An HPD staff will call the client if there will be such a requirement.

Q: Who performs the test?
A: The test is carried out in several specially qualified molecular pathology labs in Germany, Austria and Switzerland. If there is no local pathology lab to offer the test, the tumour sample can also be sent to one of these institutions. The result may thereby be delayed by a few days. Hi Precision Diagnostics will send out the specimen to a German laboratory.

 

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