NEW TEST NOTIFICATION DATE: April 6, 2017 EFFECTIVE DATE: April 10, 2017 MATEPAIR, TARGETED REARRANGEMENTS, ONCOLOGY Test ID: MTRTI USEFUL FOR: Second-tier testing in oncologic specimens when previous cytogenetic or FISH testing have detected an acquired chromosome abnormality of unknown significance Determining the size, precise breakpoints, gene content, and any unappreciated complexity of abnormalities detected by other methods such as conventional chromosome and FISH studies Providing important diagnostic, prognostic, and therapeutic information critical to proper patient management METHOD: Mate-Pair Whole Genome Sequencing REFERENCE VALUES: An interpretive report will be provided. SPECIMEN REQUIREMENTS: Previous cytogenetic or FISH testing is required in order to perform this test. If previous testing was performed at another institution, supply a copy of those results. If sufficient information regarding the patient's known chromosome abnormality is not made available, this testing will be cancelled. Provide a reason for referral with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed. Forms: New York Clients-Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing (T576) is available in Special Instructions. Submit only 1 of the following specimens: Supplies: Hank's Solution (T132) Specimen Type: Tumor biopsy Container/Tube: Sterile container with sterile Hank's balanced salt solution (T132), Ringer's solution, or normal saline Specimen Volume: 0.5-3 cm(3) or larger Supplies: Hank's Solution (T132) Specimen Type: Lymph node Container/Tube: Sterile container with sterile Hank's balanced salt solution (T132), Ringer's solution, or normal saline. Specimen Volume: 1 cm(3) Supplies: Hank's Solution (T132) Specimen Type: Skin biopsy Container/Tube: Sterile container with sterile Hank's balanced salt solution (T132), Ringer's solution, or normal saline. Specimen Volume: 4-mm diameter Collection Instructions: 1. Wash biopsy site with an antiseptic soap. 2. Thoroughly rinse area with sterile water. 3. Do not use alcohol or iodine preparations. 4. A local anesthetic may be used. 5. Biopsy specimens are best taken by punch biopsy to include full thickness of dermis. Specimen Type: Snap Frozen tissue Container/Tube: Polycon flat Specimen Volume: 3 cm(3)/Lymph Node: 1 cm(3)/Skin Biopsy: 4 mm diameter Specimen Type: Cultured tumor cells Container/Tube: T-25 flask filled with transport media Specimen Volume: T-25 flask Specimen Type: Cryo-frozen cultured tumor cells Container/Tube: Sterile container in media with DMSO or other safe cryopreservation solution Specimen Volume: 5 million cells Specimen Type: Cryo-Frozen tissue Container/Tube: Polycon flat Specimen Volume: 3 cm(3)/Lymph Node: 1 cm(3)/Skin Biopsy: 4-mm diameter SPECIMEN STABILITY INFORMATION: Specimen Type Tissue Temperature Varies Time CAUTIONS: This test is not approved by the US Food and Drug Administration and it is best used as an adjunct to existing clinical and pathologic information. This test does not detect point mutations, small deletions or insertions below the resolution of the assay, or other types of mutations such as epigenetic changes. Low level abnormal clones may not be detected by this test; as such it is not recommended for minimal residual disease monitoring. The results of this test may reveal incidental findings not related to the original reason for referral. CPT CODE: CPT CODE: Utilize the final report to determine if another CPT code is more appropriate for this testing. Search the Molecular Pathology gene table in the CPT 2017 Professional codebook for any gene variants identified in the final report. If a reported gene variant is listed in the table, the associated CPT code can be submitted for reimbursement. If a gene variant is not listed or if no gene variants are identified during testing, the 81479 code (Unlisted molecular pathology procedure) can be submitted for reimbursement DAY(S) SET UP: Samples processed Monday through Friday. Results reported Monday through Friday, 8 a.m.-5 p.m. CST ANALYTIC TIME: 14 days QUESTIONS: Contact your Mayo Medical Laboratories’ Regional Manager or Michaela Erickson/Heather Flynn-Gilmer, MML Laboratory Technologist Resource Coordinator Telephone: 800-533-1710
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