Information about changes to the R444 panel following an update to the National Genomic Test Directory

The National Genomic Test Directory is updated twice a year to include the latest tests now commissioned by NHSE.

From July 31st, the Test Directory will include an extended R444 panel to include eligibility for Talazoparib, a PARP inhibitor used in the treatment of breast cancer.

This change reflects a decision made by NICE earlier this year to license Talazoparib for the treatment of HER2-negative advanced breast cancer patients who have germline variants in BRAC1 or BRCA2 genes.

We will be accepting R444 referrals for eligible patients from July 31st with an expected turnaround time of 42 days. There is no change to the referral pathway.

In order to provide a consistent approach for all breast cancer patients, we will test for variants on all genes included on the R444.1 panel, for both Olaparib and Talazoparib referrals.

Read the NICE guidance here and find the National Genomic Test Directory here.

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With any Whole Genome Sequencing (WGS) test ordered, a Record of Discussion (RoD) form will also need to be submitted. This document is to record the patient’s consent for genomic testing and their choice on taking part in research. Guidance on the patient choice conversation can be found here
 
This RoD form will be available for clinicians to download from this webpage. Once completed with the patient, it can be send to the lab with the corresponding test order form and sample.
Tests available to order will be listed in the National Genomic Test Directory. A test order form will soon be made available for clinicians on this webpage to download and complete. This form will include the address of the laboratory that the appropriate sample and completed form needs to be sent to.
 
Until the new Genomic Laboratory Service goes live, please continue to follow existing test order processes.
 
Later this year, the online test ordering tool for Whole Genome Sequencing will be integrated into the National Genomics Informatics System (NGIS) and clinicians will be able to search or filter to find a clinical indication, confirm eligibility criteria and start the test request process for their patient.