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BRCA1/2 Analyses with CancerNext®
Test Code37714
CPT Codes
81294, 81294, 81298, 81300, 81307, 81317, 81319, 81403, 81321, 81323, 81351, 81201, 81203, 81162, 81408 (x2), 81404 (x2), 81405 (x2), 81406 (x3), 81479<br>Limited Access Code
Preferred Specimen
5 mL whole blood collected in EDTA (purple-top) tube, or 3 mL bone marrow collected in EDTA (purple-top) tube, or ACD (yellow-top) tube
Minimum Volume
3 mL whole blood
Other Acceptable Specimens
Whole blood collected in ACD (yellow-top) tube, or potassium oxalate/sodium fluoride (gray-top) tube, or sodium heparin (green-top) tube • 5 mcg extracted DNA frozen in sterile screw-cap vial
Instructions
Karyotype requires minimum 4 cc whole blood in green top (sodium heparin). At least one dedicated tube for karyotype is required. If requesting multiple tests, please submit additional tubes: Adult: 3-5cc; Pediatric: 2cc minimum; Fetal/Cord blood: 2cc minimum; Exceptions*. Next generation sequencing panels and clinical exome sequencing require 6-10cc (adult), 5cc (pediatric) minimum Chromosomal microarray for newborns: SNP Array requires 1cc minimum. Blood samples not accepted for patients that have undergone an allogenic transplant (e.g. bone marrow or peripheral stem cell) OR that have a history of chronic lymphocytic leukemia (CLL). More details listed below.*
Bone Marrow - In order of preference: 1) EDTA tube (purple top) or 2) Citric acetate tube (yellow top): Adult: 3-5cc; Pediatric: 2cc minimum. (Acceptable) Extracted DNA - Sterile plastic tube 5 mcg of DNA in low EDTA TE buffer (10mM tris-CL pH 8.0, 0.1mM EDTA); preferred 100 mcL at ~50ng/mcL concentration for multi-gene/NGS panels. DNA OD 260/280 ratio (preferred 1.7-1.9). Please send agarose picture with high molecular weight genomic DNA, if available. Single Site Analysis minimum 1-2 mcg of DNA (~100 ng/mcL concentration).
Blood: Blood in EDTA or other specimen types cannot be processed for karyotype. Transfusion patients: Wait at least 2 weeks after a packed cell/platelet transfusion, and at least 4 weeks after a whole blood transfusion prior to blood draw for testing.
--Chemotherapy patients: DNA quality may be affected if patient has received chemotherapy within the last 120 days. Clients will be contacted to provide additional specimen if DNA quality is insufficient.
--For whole blood: ship ambient for 2-day delivery (preferred) using the Ambry Sample Submission Kit, or similar. For fetal/cord blood, please call ahead and ship ambient for next-day delivery (required). Please do not ship to arrive on a holiday.
--Bone Marrow: Patients with a history of active/recent hematological disease, (e.g. leukemia, lymphoma, or myelodysplastic syndrome) will be subject to additional review prior to accessioning.
For these cases and those who have undergone allogenic transplant, cultured fibroblasts are preferred, though fresh/fresh frozen normal tissue (no fixatives) may be accepted in some cases. Please refer to Cultured Cells section (see tabs above) for those specimen requirements. If you are sending fresh/fresh frozen normal tissue samples, please call Ambry to discuss before sample submission. Room temperature for two-day delivery (preferred) in Ambry Sample Submission kit or similar.
Extracted DNA: Single Site Analysis requires minimum 1-2 mcg of DNA (~100 ng/mcL concentration) DNA should not be submitted if it has undergone multiple freeze/thaw cycles
Transfusion patients: Wait at least 2 weeks after a packed cell/platelet transfusion, and at least 4 weeks after a whole blood transfusion prior to blood draw for testing.
--Chemotherapy patients: DNA quality may be affected if patient has received chemotherapy within the last 120 days. Clients will be contacted to provide additional specimen if DNA quality is insufficient. Shipped frozen on ice/dry ice (or with cold pack, if not available) for next-day delivery (preferred) using Ambry Sample Submission kit, or similar.
Bone Marrow - In order of preference: 1) EDTA tube (purple top) or 2) Citric acetate tube (yellow top): Adult: 3-5cc; Pediatric: 2cc minimum. (Acceptable) Extracted DNA - Sterile plastic tube 5 mcg of DNA in low EDTA TE buffer (10mM tris-CL pH 8.0, 0.1mM EDTA); preferred 100 mcL at ~50ng/mcL concentration for multi-gene/NGS panels. DNA OD 260/280 ratio (preferred 1.7-1.9). Please send agarose picture with high molecular weight genomic DNA, if available. Single Site Analysis minimum 1-2 mcg of DNA (~100 ng/mcL concentration).
Blood: Blood in EDTA or other specimen types cannot be processed for karyotype. Transfusion patients: Wait at least 2 weeks after a packed cell/platelet transfusion, and at least 4 weeks after a whole blood transfusion prior to blood draw for testing.
--Chemotherapy patients: DNA quality may be affected if patient has received chemotherapy within the last 120 days. Clients will be contacted to provide additional specimen if DNA quality is insufficient.
--For whole blood: ship ambient for 2-day delivery (preferred) using the Ambry Sample Submission Kit, or similar. For fetal/cord blood, please call ahead and ship ambient for next-day delivery (required). Please do not ship to arrive on a holiday.
--Bone Marrow: Patients with a history of active/recent hematological disease, (e.g. leukemia, lymphoma, or myelodysplastic syndrome) will be subject to additional review prior to accessioning.
For these cases and those who have undergone allogenic transplant, cultured fibroblasts are preferred, though fresh/fresh frozen normal tissue (no fixatives) may be accepted in some cases. Please refer to Cultured Cells section (see tabs above) for those specimen requirements. If you are sending fresh/fresh frozen normal tissue samples, please call Ambry to discuss before sample submission. Room temperature for two-day delivery (preferred) in Ambry Sample Submission kit or similar.
Extracted DNA: Single Site Analysis requires minimum 1-2 mcg of DNA (~100 ng/mcL concentration) DNA should not be submitted if it has undergone multiple freeze/thaw cycles
Transfusion patients: Wait at least 2 weeks after a packed cell/platelet transfusion, and at least 4 weeks after a whole blood transfusion prior to blood draw for testing.
--Chemotherapy patients: DNA quality may be affected if patient has received chemotherapy within the last 120 days. Clients will be contacted to provide additional specimen if DNA quality is insufficient. Shipped frozen on ice/dry ice (or with cold pack, if not available) for next-day delivery (preferred) using Ambry Sample Submission kit, or similar.
Transport Temperature
Whole blood and bone marrow: Room temperature
Extracted DNA: Frozen
Extracted DNA: Frozen
Specimen Stability
Whole blood or bone marrow
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Contact Ambry if more than 7 days old
Extracted DNA
Room temperature: 3-4 days
Refrigerated: 1 year
Frozen: Indefinitely
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Contact Ambry if more than 7 days old
Extracted DNA
Room temperature: 3-4 days
Refrigerated: 1 year
Frozen: Indefinitely
Methodology
Polymerase Chain Reaction and Next Gen(ultra-deep)Sequencing, Sanger Sequencing, Agarose Gel Electrophoresis, Multiplex-Ligation Probe Amplification (MLPA), Next Generation Sequencing, Targeted Microarray
Setup Schedule
Set up: Mon-Sat; Report available: 14-21 days
Reference Range
See Laboratory Report
