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United States

Fulgent Therapeutics

4399 Santa Anita Ave., 91731, El Monte, CA, United States

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A2LA 6359.01ISO 15189Register refreshed 2026-11-06

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Scope lines
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A2LA certificate
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A2LA accredited scope

What this lab is accredited for

We found no published test standard numbers in this lab’s scope. The full scope as published is below.

Only this lab. Searches the method, matrix and range of each of the 2 scope lines.

A2LA certificate 6359.01 · 2 lines

LineMethodMatrixRange
1-Whole Blood (WB); Saliva Swab; Fresh Tissues
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 6359.01) 04/24/2025 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO 15189:2022 FULGENT THERAPEUTICS 4399 Santa Anita Ave. El Monte, California Ed Menezes Phone: 626-350-0537 CLINICAL Valid To: April 30, 2027 Certificate Number: 6359.01 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: Whole Blood (WB), Saliva Swab, and Fresh Tissues. Specialty Sub Specialty Test/Analyte Method Matrices Pathology Molecular Pathology Clinical/Whole Exome Next Generation Sampling WB, Saliva Swab & Fresh Tissues Custom Panel Testing Next Generation Sampling WB, Saliva Swab & Fresh Tissues Hereditary Cancer Next Generation Sampling WB, Saliva Swab & Fresh Tissues Mitochondrial Genome Next Generation Sampling WB, Saliva Swab & Fresh Tissues Newborn Genetic Analysis Next Generation Sampling WB, Saliva Swab & Fresh Tissues Rare Hereditary Disease Next Generation Sampling WB, Saliva Swab & Fresh Tissues Repeat Expansion Analysis Next Generation Sampling, PCR- based WB, Saliva Swab & Fresh Tissues Reproductive Genetic Testing Next Generation Sampling WB, Saliva Swab & Fresh Tissues Single Gene testing Next Generation Sampling WB, Saliva Swab & Fresh Tissues Targeted Mutation/Familial Genetic Testing Next Generation Sampling WB, Saliva Swab & Fresh Tissues Whole Genome Next Generation Sampling WB, Saliva Swab & Fresh Tissues
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Extracted from the scope document; tables may not line up. View scope for the original.

For the types of tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation. Accredited Laboratory A2LA has accredited FULGENT THERAPEUTICS El Monte, California for technical competence in the field of Clinical Testing 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 24th day of April 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 6359.01 Valid to April 30, 2027

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

4399 Santa Anita Ave., El Monte, CA, 91731, US

34.07516, -118.03685

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Accreditation data refreshed from the A2LA register on .

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