Test Overview
Test Methodology

The coding exon or a part of the coding exon containing the BRCA1 or BRCA2 familial mutation is amplified using specific primers, and bidirectionally sequenced using a fluorescent method.

Test Usage

BRCA1 or BRCA2 targeted sequencing can be performed on a patient with a known familial mutation. If BRCA1 or BRCA2 sequencing that detected the familial mutation was not performed at MMGL Molecular Genetics Lab, then please send a copy of the clinical laboratory report that documents the familial mutation.

Reference Range *

Interpretive report provided.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

This analysis will not identify mutations in the regulatory elements, deep intronic regions or coding regions of BRCA1 or BRCA2 that are not covered by this targeted test, and cannot detect mutations in other genes associated with hereditary breast and ovarian cancer. This assay may not detect large deletion or duplication mutations and balanced translocations involving BRCA1 or BRCA2 genes.

Test Details
Days Set Up
Monday - Friday
Analytic Time

10 - 28 days (most tests signed out within 10 days after insurance authorization is received).

Soft Order Code
BR1F/BR2F
Synonyms
  • BR1F
  • Breast Cancer
  • BR2F
Laboratory
MMGL
Section
MMGL Molecular Genetics
Specimen Requirements
Collection Instructions

Collect specimen in a lavender top tube. Send intact specimen within 24 hours if stored at room temperature or within 5 days if stored refrigerated. If the previous testing of the proband was not performed by the MMGL laboratory, please also provide a copy of the clinical molecular genetics report issued by the CLIA-certified testing laboratory for the proband, patient or family member in which the mutation was previously detected. Obtaining informed consent from the patient prior to genetic testing is strongly recommended. If desired, a UMHS Request and Consent for Genetic Testing form can be obtained from the MMGL Molecular Genetics Laboratory by contacting the MLabs Client Services Center at 800-862-7284 or online at https://mlabs.umich.edu/media/188.

Normal Volume
5 - 10 mL EDTA whole blood
Minimum Volume
5 mL EDTA whole blood
Additional Information

Most insurance carriers require prior authorization for payment. BRCA testing will not begin until insurance prior authorization is received by the MMGL Laboratory or it has been confirmed that prior authorization is not required. It is the obligation of the ordering health care provider to obtain prior authorization before testing can begin. To obtain BCN prior authorization call Joint Venture Hospital Laboratories (JVHL) at 800-445-4979; for HAP refer to CareAffiliate via www.hap.org; for all others, contact the plan directly. By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes medical geneticist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
BRF1: 81215, BRF2: 81217
Fee Code
BRF1: DA079, BRF2: DA080
Pro Fee CPT
G0452-26