BRCA1/2 gene test (HBOC) | TEST DIRECTORY

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gene-related test
germline gene analysis (assessment of indication for anti-malignant tumor drugs)
BRCA1/2 gene test (HBOC)

Laboratory：Hachioji

○BRCA1/2 gene test (HBOC)

CODE：R638 8

TEST NAME SPECIMEN
REQUIREMENT
（ｍL） CONTAINER CAP COLOR STORE
TEMPERATURE
(STABILITY) TURNAROUND
TIME (DAY) METHODOLOGY REFERENCE RANGE
(UNIT)
BRCA1/2 gene test (HBOC)
Blood (EDTA-2K added)
7
PNM
10-18 PCR and Sanger sequencing
PCR (Polymerase chain reaction)
A method for exponentially amplifying the target DNA region by using the fact that DNA dissociates from double-stranded DNA to single-stranded DNA by heating and returns to double-stranded DNA by cooling, binding the target primer to single-stranded DNA as a template, and repeatedly performing DNA synthesis by the transcription reaction of DNA polymerase.
Sanger sequencing
This method uses DNA polymerase, a DNA replication enzyme, to synthesize DNA fragments whose ends correspond to specific bases, and currently uses dideoxynucleotides labeled with four different fluorescent dyes in the elongation reaction. Sequences are determined by using a capillary electrophoresis system to detect the type of fluorescent dye of dye-terminator and the length of DNA fragments, incorporated randomly in the elongation reaction from a single primer that binds specifically to the template DNA.

COMMENT

This test is used to help identify and determine medical management of patients with breast，ovarian，or fallopian tube cancer who are at high risk for hereditary breast and ovarian cancer syndrome (HBOC).
Avoid cryopreservation. Please be sure to specify your sex when making your request. Please avoid duplicate requests with other items. This testing method increases the influence of contamination，so please be careful when handling the specimen. The number of days required may vary depending on the measurement and analysis situation.
●What is BRCA1/2 genetic testing? It is a companion diagnostic that provides clinically meaningful variant classification of patients to healthcare professionals and is used to assist in determining suitability for olaparib.
●About submission
・When requesting this test，please obtain your Myriad account ID in advance.
・Please be sure to collect blood in a special blood collection tube and submit it on the same day.
・Samples cannot be returned. Please note.
●Notes on entrustment
Persons who fall under the following conditions cannot request this item.
・Persons other than breast cancer and ovarian cancer *Cannot be used to diagnose unsymptomatic or blood relatives
・Persons with a history of allogeneic bone marrow transplantation
・Hematopoietic tumors (CLL，MDS，bone marrow proliferation) Persons who have developed a sexual disease)
・Persons whose hematopoietic tumors (ALL，AML，CML) are not in remission

●When requesting this test
Please request this test. When making a request，please read the information below and use the special request form.
1. To protect personal information，please anonymize the test subject's name and enter it in the anonymous code" field.
2. To confirm that the purpose and limitations of the test and the significance of the BRCA1/2 genes have been explained，and that written consent has been obtained from the test subject，please check.
3. For inquiries about test results，please use an anonymous code.
4. Some of the anonymized personal information will be used by Myriad Genetic Laboratories，Inc. (USA)，the measurement and analysis organization for this test，to ensure the quality of the BRCA1/2 genetic test. It may be used to improve.
5.Please check the announcements from related academic societies，etc.
●How to make a request
1. Access the dedicated request input site (https://db.myriadgenetics-ops.com/secure/login.aspx).
2. After logging in，enter the necessary request information according to the "Myriad Genetics Test Request Input System Operation Guide".
3. After completing the input，please print out the request form and submit it along with the specimen.
*Internet connection environment is required.

Collect blood in a special container，mix well，and store at room temperature. Please avoid duplicate requests with other items.
This testing method increases the influence of contamination，so please be careful when handling the specimen.
Please submit the specimen on the same day after collection."