AmoyDx® HRD Complete Panel (IVDR)

AmoyDx^® HRD Complete Panel (IVDR)

Technology

NGS

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The AmoyDx® HRD Complete Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay for qualitative detection and classification of single nucleotide variants (SNVs), insertions and deletions (InDels), and homozygous deletions (HDs) in protein coding regions and intron/exon boundaries of 20 homologous recombination repair (HRR) genes from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens in prostate cancer patients.

The detection of pathogenic or likely pathogenic BRCA1 and BRCA2 variants, with SNVs, InDels, and homozygous deletions (HDs), by this Panel is intended for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) who may be eligible for treatment with Lynparza® (olaparib) monotherapy following progression on prior therapy that included a novel hormonal agent.

Non-CDx sequence variations in genes including ATM, BARD1, BRIP1, CDH1, CDK12, CHEK1, CHEK2, FANCA, FANCL, HDAC2, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L and TP53 have either been analytically validated or have representative validation. Safe and effective use of non-CDx variants has not been established for selecting therapies.

Clinical Evidence: Meaningful rPFS Benefit
HRD Complete‒identified BRCAm subgroup:

Mutations( Hover over each mutational type to highlight genes covered )

All

SNV/INDELS

SNV/INDELS

TAT for library preparation

5 hours (hands-on time <1 hour)

Sample type

FFPE tissue

Sequencer

Illumina NextSeq 550Dx

TAT from sample to report

3 days

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AmoyDx^® HRD Complete Panel(IVDR)

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