HER2 Testing in Breast Cancer | 合法醫療器材資訊網

AccreditationchecklistrequirementsregardingHER2assayvalidation,specimenfixation,proficiencytesting,anduseoftheASCO/CAPscoringcriteriafor ...

The 2023 “Human Epidermal Growth Factor Receptor 2 (HER2) Breast Testing Guideline Update”[1] reaffirms the 2018 “HER2 Breast Testing Guideline Focused Update.”

This reaffirmation was propelled by results of the 2022 DESTINY-Breast04 trial, which prompted the United States Food and Drug Administration (FDA) to expand the approval of the HER2 antibody-drug conjugate, trastuzumab deruxtecan, from metastatic breast cancer patients with HER2 protein over-expression/amplification to also include metastatic patients with HER2 IHC 1+ or 2+/ISH negative results.

This guideline update does not support the use of a HER2-Low interpretive category because the DESTINY-Breast04 trial did not include patients with HER2 IHC 0 results, there is no evidence to support that IHC 1+ or 2+/ISH negative results are predictive of trastuzumab deruxtecan treatment response when compared to IHC 0 results. Therefo...

HER2 Testing in Breast Cancer | 合法醫療器材資訊網

Accreditation checklist requirements regarding HER2 assay validation, specimen fixation, proficiency testing, and use of the ASCO/CAP scoring criteria for ... Read More

ASCO CAP 2018 HER2 Testing for Breast Cancer ... | 合法醫療器材資訊網

Duration of fixation: 6-72 hours. These requirements apply to core biopsies and resections. There are no changes to ASCO CAP's 2013 HER2 testing guidelines ... Read More

HER2 | 合法醫療器材資訊網

This is a tool based on an ASCO and CAP guideline and is not intended to substitute for the independent professional judgment of the treating physician. Read More

Estrogen and Progesterone Receptor Testing in Breast ... | 合法醫療器材資訊網

由 KH Allison 著作 · 2020 · 被引用 129 次 — PURPOSETo update key recommendations of the American Society of ... Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. Read More

Adding precision to 2018 ASCOCAP HER2 testing guidelines ... | 合法醫療器材資訊網

由 A Brufsky 著作 · 2020 — Previous work showed a substantial proportion of tumors identified as HER2 equivocal or HER2 positive by 2013 ASCO/CAP guidelines may ... Read More

Update to ASCOCAP Guideline in Breast Cancer | 合法醫療器材資訊網

2020年1月21日 — An update to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) clinical practice guideline on estrogen ... Read More

Applying the New Guidelines of HER2 Testing in Breast Cancer | 合法醫療器材資訊網

由 H Zhang 著作 · 2020 · 被引用 7 次 — The American Society of Clinical Oncology/College of American Pathology (ASCO/CAP) has published HER2 testing guidelines in breast ... Read More

Summary of ASCOCAP ER and PgR Guideline ... | 合法醫療器材資訊網

Accession slip and report must include guideline-detailed elements. Optimal algorithm for ER/PgR testing. Optimal testing conditions. Summary of ASCO/CAP ... Read More

er pgr guideline update | 合法醫療器材資訊網

2020年1月13日 — Cancer: ASCO/CAP 2020 Guideline Update. Date: January 13, 2020. Background: The CAP and the American Society of Clinical Oncology ... Read More

Guideline Summary | 合法醫療器材資訊網

The Panel recommends that HER2 status be determined for all invasive breast cancers. Methodology. The ASCO/CAP Expert Panel used evidence from January ... Read More

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