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A profile on the FoundationFocus CDxBRCA tests.

Lindsey Ford1, Juliet E Wolford1, Sandra M Brown2

  • 1Chao Family Comprehensive Cancer Center, University of California Irvine Health, Orange, CA, USA.

Expert Review of Molecular Diagnostics
|February 8, 2020
PubMed
Summary
This summary is machine-generated.

Poly(ADP-ribose) polymerase (PARP) inhibitors and companion diagnostics like Foundation Focus CDxBRCA are crucial for treating ovarian cancer. Genomic testing identifies mutations predicting response to PARP inhibitors, improving patient outcomes.

Keywords:
PARP inhibitorRucaparibcompanion diagnosticfoundation focushomologous recombination deficiencyloss of heterozygosity (LOH)next-generation sequencingovarian cancerpredictive biomarker

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Area of Science:

  • Oncology
  • Genomics
  • Pharmacology

Background:

  • PARP inhibitors are approved for recurrent epithelial ovarian carcinoma, with rucaparib being a key example.
  • Foundation Focus CDxBRCA is an FDA-cleared assay for detecting BRCA1/2 mutations, guiding PARP inhibitor therapy.
  • Genomic biomarkers, including BRCA mutations and Loss of Heterozygosity (LOH), are vital for predicting response to PARP inhibitors.

Purpose of the Study:

  • To discuss the evolution of genomic testing in ovarian cancer concerning PARP inhibition.
  • To highlight the role of Foundation Focus CDxBRCA and CDxBRCA LOH as complementary diagnostics for rucaparib.
  • To review the predictive value of BRCA mutations and LOH for PARP inhibitor efficacy.

Main Methods:

  • Review of the literature on PARP inhibitors and ovarian cancer genomic testing.
  • Focus on the Foundation Focus CDxBRCA assay and its validation for detecting germline and somatic BRCA mutations.
  • Analysis of clinical trial data supporting the use of LOH as a biomarker and its inclusion in diagnostic assays.

Main Results:

  • Women with BRCA1/2 mutations show higher response rates and durability to PARP inhibitors.
  • Loss of Heterozygosity (LOH) is also a validated predictive biomarker for PARP inhibitor response.
  • The Foundation Focus CDxBRCA assay, including LOH detection, supports rucaparib's expanded FDA label for maintenance therapy.

Conclusions:

  • Genomic biomarkers and companion diagnostics are essential for targeted PARP inhibitor therapy in ovarian cancer.
  • The co-development of high-performance diagnostics is critical due to the complexity of PARP biomarkers.
  • Advancements in testing, like the inclusion of LOH, enhance the utility of PARP inhibitors and expand treatment options.