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United States

Myriad Genetic

322 N 2200 W, 84116, Salt Lake City, UT, United States

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A2LA 5165.01ISO 15189Register refreshed 2026-11-06

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Scope lines
3
A2LA certificate
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1
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 3 scope lines.

A2LA certificate 5165.01 · 3 lines

LineMethodMatrixRange
1-human samples, including Saliva (S); Whole Blood (WB); Formalin Fixed Paraffin Embedded (FFPE) Samples; Extracted DNA; Extracted RNA; WB; S; FFPE Sample; Extracted RNA
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 5165.01) REVISED 10/20/2025 Page 1 of 2 SCOPE OF ACCREDITATION TO ISO 15189:2022 MYRIAD GENETIC LABORATORIES 322 North 2200 West Salt Lake City, UT 84116 Dr. Benjamin B. Roa Phone: 801-584-3049 CLINICAL Valid To: March 31, 2027 Certificate Number: 5165.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following testing on human samples, including Saliva (S), Whole Blood (WB) , Formalin Fixed Paraffin Embedded (FFPE) Samples, Extracted DNA, and Extracted RNA: Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Molecular Pathology BRACAnalysis CDxTM Genetic Mutation Detection Targeting BRCA1/BRCA2, FDA- Approved for Companion Diagnostic Use Sanger Sequencing, PCR WB BRACAnalysis® Hereditary Breast and Ovarian Mutation Detection Targeting BRCA1/BRCA2 Next Generation Sequencing WB, S BRACAnalysis® 診断システム HBOC Syndrome Mutation Detection Targeting BRCA1/BRCA2, Approved by Japan’s MHLW for CDx Use Sanger Sequencing, PCR WB Colaris AP® Hereditary Mutation Detection Targeting APC, MYH Next Generation Sequencing WB, S Colaris® Hereditary Mutation Detection Targeting MLH1, MSH2, MSH6, PMS2 Next Generation Sequencing WB, S EndoPredict® Breast Cancer Recurrence Score Quantitative Reverse Transcription-PCR FFPE Sample, Extracted RNA Melaris® Hereditary Mutation Detection Targeting CDKN2A, INK4A Next Generation Sequencing WB, S
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2-FFPE Sample, Extracted DNA; WB, S; FFPE
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 5165.01) REVISED 10/20/2025 Page 2 of 2 Specialty Sub Specialty Test/Analyte Method(s) Matrix(ces) Pathology Molecular Pathology (cont.) myChoice® Homologous Recombination Deficiency (HRD) and Mutation Detection Test Offerings include: • myChoice® CDx – GIS + B1/B2, FDA Approved for CDx use • myChoice® 診断システム – GIS + B1/B2, Approved by Japan’s MHLW for CDx Use • myChoice® CDx PLUS – GIS + B1/B2 or GIS + 15 Gene Panel, CE Marked for CDx Use • myChoice® HRD – GIS + B1/B2 (no CDx claims) Next Generation Sequencing FFPE Sample, Extracted DNA myRiskTM Hereditary Cancer Next Generation Sequencing WB, S PanexiaTM Hereditary Mutation Detection Targeting PALB2, BRCA2 Next Generation Sequencing WB, S Precise TM Solid Tumor Assay Next Generation Sequencing FFPE Prolaris® Prostate Cancer Prognosis Score Quantitative Reverse Transcription-PCR FFPE Sample, Extracted RNA
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Extracted from the scope document; tables may not line up. View scope for the original.

For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation. Accredited Laboratory A2LA has accredited MYRIAD GENETIC LABORATORIES Salt Lake City, UT 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 February 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 5165.01 Valid to March 31, 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

322 N 2200 W, Salt Lake City, UT, 84116, US

40.75962, -111.88680

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