Implementation and Audit of Mainstream Genetic Testing Within a High‐Volume UK Breast Unit for Pathogenic Variations Associated With Breast Cancer Using the R208 and R444.1 National Test Directory Criterion.

Introduction: It is estimated that 5%–10% of patients who develop breast cancer have a causative inherited pathogenic or likely pathogenic variant (P/LP variant). In 2020, the UK National Test Directory published criteria for mainstream genetic testing for breast cancer patients (R208) and, subseque...

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Publicado en:Breast Journal Vol. 2026; pp. 1 - 15
Autores principales: Conroy, Soraya, Keane, Emma, Rehman, Bushra, Wyborn, Eleanor, Brown, Catherine, Chen, Lamb, Chatten, Josh, Durston-Rand, Elijah, Sheehan, Blaise, Ferguson, Elizabeth, Miles, Tracie, Beck, Emma, Hunter-Smith, Alison, Laban, Christiana, Smith, Katherine, Dalgliesh, Diana, Bowen, Rebecca, Laurence, Nicola, Wani, Imtiaz
Formato: pictorial research tables/charts Journal Article
Publicado: Wiley-Blackwell 7/27/2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 7/27/2026
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1155/tbj/2657384
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        atl: Implementation and Audit of Mainstream Genetic Testing Within a High‐Volume UK Breast Unit for Pathogenic Variations Associated With Breast Cancer Using the R208 and R444.1 National Test Directory Criterion.
      aug:
        au:
          Conroy, Soraya
          Keane, Emma
          Rehman, Bushra
          Wyborn, Eleanor
          Brown, Catherine
          Chen, Lamb
          Chatten, Josh
          Durston-Rand, Elijah
          Sheehan, Blaise
          Ferguson, Elizabeth
          Miles, Tracie
          Beck, Emma
          Hunter-Smith, Alison
          Laban, Christiana
          Smith, Katherine
          Dalgliesh, Diana
          Bowen, Rebecca
          Laurence, Nicola
          Wani, Imtiaz
        affil: Breast Unit,, Royal United Hospital,, Bath, UK
      sug:
        subj:
          Breast Neoplasms Familial and Genetic
          Breast Neoplasms Pathology
          Genetic Variation
          Genetic Screening Methods
          Oncology Care Units Administration
          Audit
          Program Implementation
          Program Evaluation
          National Health Programs Standards
          Human
          Female
          Adult
          Middle Age
          Aged
          United Kingdom
          Cancer Care Facilities
          Cancer Screening
          Hospital Programs
          Oncogenes
          Gene Expression
          Registries, Disease
          Genomics
          Cancer Patients
          Breast Neoplasms Surgery
          Mastectomy
          Prospective Studies
          Questionnaires
          Tumor Markers, Biological
          Eligibility Determination
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Aged: 65+ years
          Female
      ab: Introduction: It is estimated that 5%–10% of patients who develop breast cancer have a causative inherited pathogenic or likely pathogenic variant (P/LP variant). In 2020, the UK National Test Directory published criteria for mainstream genetic testing for breast cancer patients (R208) and, subsequently, eligibility criteria to determine which patients are eligible for gene testing and PARP inhibitor treatment (R444.1). Methods: Using the clearly defined criteria from NHS genomics, eligibility for testing under R208/R444.1 was determined for all patients diagnosed with breast cancer between March 2021 and March 2025. Eligible patients were offered genetic testing. Incidence of P/LP variants and impact on treatment were examined. Results: A total of 1812 patients had new DCIS/invasive breast cancer diagnoses, 255 were eligible for testing and 196 consented. Of these, 28 patients (14.3%) had a P/LP variant. Eight of these patients were eligible only using family history criteria. Twenty‐one patients were eligible for breast conservation surgery. Preoperative genetic results were available for 13: eight patients opted for bilateral mastectomy rather than breast conservation. Where results were available postoperatively, three of eight patients who had breast conservation are planning bilateral risk reducing surgery. Three women newly diagnosed with a BRCA variant received a PARP inhibitor. Eligibility assessment for testing was time‐consuming for trained clinicians. Conclusion: 14.3% of patients eligible and tested for a breast cancer–related hereditary P/LP variant were positive, which aligns with the expected number predicted by Genomics England. Family history scoring is an important element. Positive results were associated with changes in surgical decision‐making for 14 women and enabled 3 patients to receive a PARP inhibitor.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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