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Order or find a test

The National Genomic Test Directories specify which genomic tests are commissioned by the NHS in England, to be delivered by Genomic Laboratory Hubs.

Clinical Indication ID & Name

R444

NICE approved PARP inhibitor treatment – breast cancer | NICE approved PARP inhibitor treatment – prostate cancer

Test Group

Core

Specialties

Clinical Genetics Surgery Oncology

Test code

R444.1

Test name

N/A

Target genes

BRCA1; BRCA2;

Test scope

Small variants, CNVs

Test method/ technology

Small panel

Optimal Family Structure

n/a

Eligibility Criteria

Testing Criteria only applies to patients not meeting R208/R430 criteria AND with current cancer diagnosis for treatment decisions.
R444.1 Breast Cancer
1.For people with triple negative breast cancer who have received neo-adjuvant chemotherapy:
residual invasive cancer in the breast, the resected lymph nodes (non-pathological complete response) or both at the time of surgery
2.For people with triple-negative breast cancer having adjuvant chemotherapy:
▪node-positive OR
▪node-negative cancer with a primary tumour ≥ 2 cm
3.For people with hormone receptor-positive, HER2-negative breast cancer who have received neoadjuvant chemotherapy:
▪residual invasive cancer in the breast, the resected lymph nodes (non-pathologic complete response) or both at the time of surgery, AND
▪a CPS + EG score of ≥3 based on pre-treatment clinical and posttreatment pathological stage, receptor status and histological grade
4.For people with hormone receptor-positive, HER2-negative breast cancer having adjuvant chemotherapy:
▪4 or more pathologically confirmed positive lymph nodes.
5.For people who have HER2-negative locally advanced or metastatic breast cancer:
▪Patients should have been previously treated with an anthracycline and/or a taxane in the neo/adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.
▪Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
R444.2 Prostate Cancer
Metastatic, castration-resistant prostate cancer where somatic tumour testing (M218.1) has failed.

Test code

R444.2

Test name

N/A

Target genes

BRCA1, BRCA2

Test scope

Small variants, CNVs

Test method/ technology

Small panel

Optimal Family Structure

n/a

Eligibility Criteria

Testing Criteria only applies to patients not meeting R208/R430 criteria AND with current cancer diagnosis for treatment decisions.
R444.1 Breast Cancer
1.For people with triple negative breast cancer who have received neo-adjuvant chemotherapy:
residual invasive cancer in the breast, the resected lymph nodes (non-pathological complete response) or both at the time of surgery
2.For people with triple-negative breast cancer having adjuvant chemotherapy:
▪node-positive OR
▪node-negative cancer with a primary tumour ≥ 2 cm
3.For people with hormone receptor-positive, HER2-negative breast cancer who have received neoadjuvant chemotherapy:
▪residual invasive cancer in the breast, the resected lymph nodes (non-pathologic complete response) or both at the time of surgery, AND
▪a CPS + EG score of ≥3 based on pre-treatment clinical and posttreatment pathological stage, receptor status and histological grade
4.For people with hormone receptor-positive, HER2-negative breast cancer having adjuvant chemotherapy:
▪4 or more pathologically confirmed positive lymph nodes.
5.For people who have HER2-negative locally advanced or metastatic breast cancer:
▪Patients should have been previously treated with an anthracycline and/or a taxane in the neo/adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.
▪Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
R444.2 Prostate Cancer
Metastatic, castration-resistant prostate cancer where somatic tumour testing (M218.1) has failed.

Commissioning group

Core

Overlapping idications

•R208 Inherited breast cancer and ovarian cancer •R430 Inherited prostate cancer •M3 breast cancer should be used for somatic testing •M218 prostate cancer should be used for somatic testing Referrals for testing will be triaged by the Genomic Laboratory; testing should be targeted at those where a genetic or genomic diagnosis will guide management for the proband or family.

Address for samples/request forms

Genetics Laboratory
5th Floor Tower Wing
Guy’s Hospital
London
SE1 9RT

Contact with queries

gst-tr.southeastglh@nhs.net

Supporting documents

n/a

Education resources

n/a

Turn around times

All our turnaround times are listed on our specific turn around page https://southeastgenomics.nhs.uk/professionals/service-turn-around-times/

Request form download

Rare Disease Order Form Record of Discussion Form

Consent record

See consent guidance in test request form

Sample requirements

Sample Requirements Each sample must be sent labelled with 3 patient identifiers and must state the sample type clearly on the sample container. Sample Rejection Samples may be rejected for the following reasons: 1. Samples and request form do not show at least three identical patient identifiers 2. The sample is in the incorrect collection media 3. The request form is not sufficiently completed 4. The sample is not of sufficient volume 5. The sample is too old