Example HRRm Commercial
Laboratory Options
Explore currently available testing options and decide which is most appropriate based on sample type and HRR alteration coverage.* Bookmark and refer back to this page. We’ll update this page periodically as new information on tests becomes available.
TUMOR TISSUE
ctDNA (BLOOD PLASMA)
BLOOD/SALIVA
HRR Lab Option Overview
HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated.
- Other tests may be available that could cover HRR genes. These are the tests that are most likely being used to test for prostate cancer.
- Risk-conferring germline mutations in tumor tests are incidental findings and should be evaluated in a germline setting.30
*Not FDA-approved tests. These are Laboratory Developed Tests (LDTs), which are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements. Although LDTs must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet the regulatory requirements under CLIA to perform high complexity testing, these tests are not individually FDA-approved.
The diagnostic tests listed are generally commercially available HRR alteration gene panels. List is current as of October 2024. Tests listed may include analysis of genes outside of HRR pathways.
This information is intended as educational only and is not intended as a complete list of available testing options. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. Pfizer is not responsible for any test provider and does not endorse or recommend any particular diagnostic test. The accuracy and results of diagnostic tests vary, and Pfizer shall have no liability arising from such testing. The information provided herein should in no way be considered a guarantee of coverage, reimbursement, availability, or patient assistance. Providers should contact third-party laboratories for information.