Seraseq® ctDNA Prostate Mix AF0.5%

INTRODUCTION

While early-stage prostate cancer is often able to be surgically cured, castration resistant metastatic prostate cancer (mCRPC) is a difficult disease to manage with a 5-year survival rate of about 30%. Recent advances have shown that mCRPC can be managed with PARP inhibitor therapy if there are appropriate homologous recombination repair (HRR) gene mutation present in the tumor.

LGC Clinical Diagnostics has produced the Seraseq ctDNA Prostate Mix to aid in labs wanting to know the HRR status of ctDNA from mCRPC as well as survey for canonical mutations to monitor for recurrence of disease. The diverse set of 48 mutations present include SNVs, insertions, deletions, indels, duplications, translocations and CNVs making this the best-in-class reference material on the market.

FEATURES AND BENEFITS

• Validate and monitor performance of cfDNA prostate cancer assays using well defined, precisely built reference materials

• Variants present at 1% or 0.5% Variant Allele Frequency (VAF)

• Mutation targets are quantitated using highly sensitive digital PCR

• Orthogonal NGS data as well to support variant allele frequencies present and compare between assays

• Affordably priced for routine use

• All mutations are blended against GM24385 human genomic DNA as background ‘wild type’ material

• Manufactured in GMP-compliant and ISO 13485-certified facilities