Genomic Health
Redwood City, CA, United States
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Register record
- A2LARefreshed
- 3922.01Active
Accredited standards
We have not yet extracted the standard numbers from this lab’s scope document. The scope text we hold is below.
Scope as published by A2LA
2 lines
ISO/IEC 17025
Active3922.01
The scope document we hold says it is valid until 2028-03-31.
Accredited scope, certificate 3922.01
This scope has not been split into individual lines yet. Below is the text of the scope document as published.
Part 1 of 2
(A2LA Cert. No. 3922.01) 04/08/2026 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO 15189:2022 GENOMIC HEALTH, INC. 301 Penobscot Drive Redwood City, CA 94063 Dr. Thuy Can Phone: 650-569-2111 CLINICAL Valid To: March 31, 2028 Certificate Number: 3922.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including: formalin fixed paraffin embedded (FFPE) samples. Specialty Sub Specialty Test/Analyte Method Matrix Pathology Molecular Pathology Oncotype DX ® Breast DCIS Score RT-PCR FFPE samples Oncotype DX ® Breast Recurrence Score RT-PCR FFPE samples Oncotype DX ® Colon Recurrence Score RT-PCR FFPE samples
Part 2 of 2
For the tests which this accreditation applies, please refer to the laboratory’s «field» Scope of Accreditation. Accredited Laboratory A2LA has accredited GENOMIC HEALTH INC. Redwood City, CA for technical competence in the field of Clinical This laboratory is accredited in accordance with the recognized International Standard ISO 15189:2022 Medical laboratories - Requirements for quality and competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint IAF-ILAC-ISO Communiqué dated November 2021). Presented this 8th day of April 2026. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 3922.01 Valid to March 31, 2028
Text extracted from the accredited scope document. Layout and tables from the original may not carry over; the scope document itself is the authoritative copy.
Other Locations
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