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TumorNext-HRD

Women with ovarian cancer need a reliable test to assess for hereditary cancer and guide targeted treatment decisions. TumorNext-HRD is a paired tumor and germline analysis of BRCA1 and BRCA2 plus 9 additional genes in the homologous recombination repair pathway. Looking at both the tumor and germline can provide more complete information to guide ovarian cancer management.
Ovarian Cancer Genetic Testing | TumorNext-HRD

Women with ovarian cancer need a reliable test to assess for hereditary cancer and guide targeted treatment decisions. TumorNext-HRD is a paired tumor and germline analysis of BRCA1 and BRCA2 plus 9 additional genes in the homologous recombination repair pathway. Looking at both the tumor and germline can provide more complete information to guide ovarian cancer management.

TumorNext-HRD targets detection of germline and somatic variants in genes in the homologous recombination repair pathway (ATM, BARD1, BRCA1, BRCA2, BRIP1, CHEK2, MRE11A, NBN, PALB2, RAD51C, and RAD51D). Genomic deoxyribonucleic acid (gDNA) is isolated from the patient’s specimen(s) using standardized methodology and quantified. For FFPE section, one thin (5 micron) tissue section is first cut and stained with hematoxylin and eosin (H&E). The H&E slide is examined by a pathologist to determine tissue quantity/quality and neoplastic cellularity (20% minimum). Sequence enrichment of the germline and tumor sample for the targeted coding exons and adjacent intronic nucleotides is carried out by a bait-capture methodology using long biotinylated oligonucleotide probes followed by polymerase chain reaction (PCR) and Next-Generation sequencing (NGS). The bioinformatics pipeline performs paired analysis of sequence data from both tumor and germline specimens to differentiate variants of somatic origin from germline origin. Optimized variant calling filters require a read coverage depth of >100X for tumor and > 20X for matched control blood DNA. For molecular analysis of variants of germline origin only, additional Sanger sequencing is performed for any regions missing or with insufficient read depth coverage for reliable heterozygous variant detection. Suspect variant calls of germline origin other than those classified as “likely benign” or “benign” detected on the paired analysis are verified by Sanger sequencing. The BRCA2 Portuguese founder mutation, c.156_157insAlu (also known as 384insAlu) is detected by  multiplex ligation-dependent probe amplification (MLPA). Germline gross deletion/duplication analysis of all sequenced genes is performed using targeted chromosomal microarray with confirmatory MLPA when applicable. 

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  1. SGO Clinical Practice Statement: Genetic Testing for Ovarian Cancer. October 2014 

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TumorNext-HRD can detect and differentiate between germline and somatic mutations in homologous recombination repair genes including BRCA1 and BRCA2 so that you can: Identify ovarian cancer patients who are at an increased risk for other cancers Identify patients who have family members that may be at a significantly increased risk for cancer and clarify management recommendations Learn if there are variants in the tumor that may cause homologous recombination deficiency (HRD) Guide targeted treatment, such as with PARP inhibitors1-11