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：Akiruno

○BRCA1/2 gene test (HBOC)

CODE：0R638 6

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)
7.0
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

The test is used to identify patients at high risk for hereditary breast-ovarian carcinoma syndrome (HBOC) among patients with breast, ovarian or fallopian tube carcinoma, and to assist in determining medical management.
Avoid freezing. Please be sure to specify your sex when making your request. Avoid duplicate requests with other items. This testing method can be affected by contamination, so 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 used to provide medical professionals with a clinically meaningful variant classification of patients and to assist in determining the indication for olaparib.
*For breast carcinoma only, it is a companion diagnostic used to assist in determining the indication for olaparib and talazoparib tosylate.
●About submission
・When requesting this test, obtain your Myriad account ID in advance.
・Be sure to collect blood in a special blood collection tube and submit it on the same day.
・Samples cannot be returned thank you for your understanding.
●Precautions for consignment
Persons who fall under the following conditions cannot request this item.
・Persons other than breast carcinoma and ovarian carcinoma *Cannot be used to diagnose asymptomatic 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
When making a request, please read the information below and use the special request form.
1. To protect personal information, 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.
3. For inquiries about test results, 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. Check the announcements from related academic societies, etc.
●How to make a request
1. Access the dedicated request entry 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, 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. Avoid duplicate requests with other items.
This testing method can be affected by contamination, so be careful when handling the specimen.
Please submit the specimen on the same day after collection.