よむ、つかう、まなぶ。
参考資料４_Action plan for whole genome analysis 2022 (25 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_33324.html |
| 出典情報 | 厚生科学審議会 科学技術部会全ゲノム解析等の推進に関する専門委員会（第15回 5／25）《厚生労働省》 |
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(b) Sequencing companies
Under the present Action Plan, uniform, high-quality analysis data will be
collected using a standardized methodology. Technologies for which analysis
methods have been established will be outsourced to companies that satisfy
all of the following five conditions:
1) The company has an analysis base in Japan, and security is ensured by
measures that include restricting the range of persons with access
privileges, monitoring access, strengthening identity authentication
(introduction of multi-factor authentication), data sanitization, and real-time
detection of unauthorized access. Risk and security assessments are
conducted on a regular basis by third parties, and the person in charge
takes appropriate action if issues are identified.
2) The company has a proven record of sequencing more than a certain
number of samples and is capable of sequencing large numbers of samples.
3) The company is a clinical laboratory, etc. that carries out accuracy
management for genetic testing.5
4) The company is capable of sequencing that meets the specifications for
international joint research with countries that are advanced in genome
analysis.
5) From the perspective of obtaining uniform data, the company has multiple
next-generation sequencers with a standardized system.
In addition, to ensure and to improve sequencing accuracy, sequencing
companies are required to conduct their own regular quality evaluation and
verification, and to also have external accuracy management.6
5
The company must be ISO 15189 certified (Japan Accreditation Board), CAP-LAP certified
(College of American Pathologists Laboratory Accreditation Program), or CLIA certified (Clinical
Laboratory Improvement Amendments).
6 During FY2022, external accuracy management will be conducted by the MHLW Science
Research Group for promotion of whole genome analysis of cancer and establishment of a system
for technology assessment related to whole genome analysis of each individual patient and its
clinical application, a center for data analysis and storage, information security and patient
confidentiality, and Ethical Legal and Social Implications (ELSI) (tentative name), which will use
the sequencing accuracy, the relevant summary values, and the pre-mapping quality control
values of the sequencing companies. After the Project Implementation Organization has been
established, this organization will carry out external accuracy management of companies.
24
Under the present Action Plan, uniform, high-quality analysis data will be
collected using a standardized methodology. Technologies for which analysis
methods have been established will be outsourced to companies that satisfy
all of the following five conditions:
1) The company has an analysis base in Japan, and security is ensured by
measures that include restricting the range of persons with access
privileges, monitoring access, strengthening identity authentication
(introduction of multi-factor authentication), data sanitization, and real-time
detection of unauthorized access. Risk and security assessments are
conducted on a regular basis by third parties, and the person in charge
takes appropriate action if issues are identified.
2) The company has a proven record of sequencing more than a certain
number of samples and is capable of sequencing large numbers of samples.
3) The company is a clinical laboratory, etc. that carries out accuracy
management for genetic testing.5
4) The company is capable of sequencing that meets the specifications for
international joint research with countries that are advanced in genome
analysis.
5) From the perspective of obtaining uniform data, the company has multiple
next-generation sequencers with a standardized system.
In addition, to ensure and to improve sequencing accuracy, sequencing
companies are required to conduct their own regular quality evaluation and
verification, and to also have external accuracy management.6
5
The company must be ISO 15189 certified (Japan Accreditation Board), CAP-LAP certified
(College of American Pathologists Laboratory Accreditation Program), or CLIA certified (Clinical
Laboratory Improvement Amendments).
6 During FY2022, external accuracy management will be conducted by the MHLW Science
Research Group for promotion of whole genome analysis of cancer and establishment of a system
for technology assessment related to whole genome analysis of each individual patient and its
clinical application, a center for data analysis and storage, information security and patient
confidentiality, and Ethical Legal and Social Implications (ELSI) (tentative name), which will use
the sequencing accuracy, the relevant summary values, and the pre-mapping quality control
values of the sequencing companies. After the Project Implementation Organization has been
established, this organization will carry out external accuracy management of companies.
24