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Available tests

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

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HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated.

  1. 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.
  2. 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.

GenPath Diagnostics. OnkoSight Advanced™. Accessed August 2024. https://www.genpathdiagnostics.com/hcp/onkosight-advanced-tm-next-generation-sequencing/#toggle-id-11
Caris Life Sciences. MI Tumor Seek™. Accessed August 2024. https://www.carislifesciences.com/wp-content/uploads/2024/05/TN0713-v2-Profile-Menu-Tissue-Blood_Singles.pdf
Caris Life Sciences. Comprehensive Molecular Profiling. Accessed August 2024. https://www.carislifesciences.com/wp-content/uploads/2024/05/TN0713-v2-Profile-Menu-Tissue-Blood_Singles.pdf
Exact Sciences. OncoExTra® for Advanced Prostate Cancer. Accessed August 2024. https://precisiononcology.exactsciences.com/-/media/project/precisiononcology/precisiononcology/files/oncoextra/oncoextra-prostate-overview-1-pager.pdf?rev=b456d46e5a904982b629681b33067a6d&hash=66C593E1AE6040AF63C79E7E3525226C
Foundation Medicine. FoundationOne CDx. Accessed August 2024. https://www.foundationmedicine.com/sites/default/files/media/documents/2024-01/F1CDxTechnicalSpecificationsSPEC-01197.pdf
GoPath Diagnostics. OncoTarget500®. Accessed August 2024. https://oncotargetdx.com/oncotarget500
Labcorp. OmniSeq INSIGHT®. Accessed August 2024. https://www.labcorp.com/tests/831177/omniseq-insight
Labcorp. OmniSeq INSIGHT® Gene List. Accessed August 2024. https://www.labcorp.com/assets-media/2667
Myriad Genetics. Precise™ Tumor – HCP Detailed Brochure. Accessed August 2024. https://eng1e.seismic.com/i/CzihLEzG0BiSL8nKNdPLUSSIGNhgIMk3Olq5AW9S0e7QCUgUqbmQgkFat4W7r3do5L618E1mX6uy2AgThhuLk3Md63PLUSSIGNuZDDtcY8QJtExnhJgu9nk7DVAFW5ulrzndzyVfysXvyI
NeoGenomics. NeoTYPE® HRR Profile. Accessed August 2024. https://neogenomics.com/test-menu/neotyper-hrr-profile
Quest Diagnostics. Solid Tumor Expanded Panel. Accessed August 2024. https://www.questdiagnostics.com/healthcare-professionals/clinical-education-center/faq/faq273
Tempus. Tempus xT Validation. Accessed August 2024.https://www.tempus.com/wp-content/uploads/2024/05/Tempus-xT_Validation.pdf
Foundation Medicine. FoundationOne® Liquid. Accessed August 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190032C.pdf
Guardant Health. Guardant360® CDx. Accessed August 2024. https://www.guardantcomplete.com/assets/pdf/Guardant360-CDx-Technical-Information-US.pdf
Guardant Health. Guardant360®. Accessed August 2024. https://www.guardantcomplete.com/assets/pdf/Guardant360-Specification-Sheet.pdf
Tempus. Tempus xF+ Validation. Accessed August 2024. https://www.tempus.com/wp-content/uploads/2024/02/Tempus-xFPlus_Validation.pdf
Ambry Genetics. CancerNext Expanded®. Accessed June 2024. https://www.ambrygen.com/providers/genetic-testing/28/oncology/cancernext-expanded
Ambry Genetics. ProstateNext®. Accessed June 2024. https://www.ambrygen.com/providers/genetic-testing/5/oncology/prostatenext
GenPath Diagnostics. OnkoRisk™ Hereditary Oncology Plus Panel. Accessed August 2024. https://www.genpathdiagnostics.com/hcp/oncology/hereditary-cancer-testing/specimen-requirements/
GenPath Diagnostics. OnkoRisk™ Hereditary Oncology Plus Panel Gene List. Accessed August 2024. https://www.genpathdiagnostics.com/hcp/oncology/hereditary-cancer-testing/hereditary-cancer-testing-options/#toggle-id-6
Exact Sciences. Riskguard™. Accessed August 2024. https://www.exactsciences.com/-/media/project/exactcore/documents/riskguard/hct-gene-chart.pdf?rev=6744870aeb694537a2e17b6002a35083&hash=904346088D825A2F71D82BCBE57A6EED
Exact Sciences. Riskguard™. Accessed August 2024. https://www.exactsciences.com/Our-Tests/riskguard/provider#started
GoPath Diagnostics. ProstateNOW. Accessed August 2024. https://gopathdx.com/test-menu/tproduct/542994917-775344969181-prostatenow
GoPath Diagnostics. Delivering clarity for a better tomorrow. ProstateNOW. Accessed August 2024. https://geneticsnow.com/prostatenow
Invitae. Multi-Cancer Panel. Accessed August 2024. https://www.invitae.com/us/providers/test-catalog/test-01101/
Labcorp. VistaSeq® Hereditary Cancer Panel. Accessed October 2024. https://www.labcorp.com/tests/481220/vistaseq-hereditary-cancer-panel
Myriad Genetics. Myriad BRACAnalysis®, COLARIS®, COLARIS® AP, and MyRisk® Hereditary Cancer Technical Specifications. Accessed August 2024. https://s3.amazonaws.com/myriad-library/technical-specifications/myRisk+Hereditary+Cancer+Tech+Specs.pdf
Quest Diagnostics. Comprehensive Hereditary Cancer Panel. Accessed August 2024. https://testdirectory.questdiagnostics.com/test/test-detail/38600/comprehensive-hereditary-cancer-panel?cc=MASTER
Tempus. Tempus xG Overview. Accessed August 2024. https://www.tempus.com/wp-content/uploads/2022/09/Tempus-xG_Overview.pdf
Yap TA et al. Am Soc Clin Oncol Educ Book 2023;43:e390738