Donor-Derived Circulating Cell-Free DNA (ccfDNA) Reference Materials for Concordance Studies

The limited quantities of ccfDNA in plasma and the limited amount of ccfDNA that can therefore be obtained from a single donor can make it difficult to assess the sensitivities and specificities of circulating tumor DNA (ctDNA) assays because there is often insufficient material to confirm the presence or absence of particular mutations by orthogonal assays.

Additionally, there have been reports of discordance between different ctDNA assays with patient samples at lower variant allele frequencies (VAFs). The limited and ephemeral nature of patient samples has been a bottleneck to investigating and resolving the causes of discordance. To overcome this, we developed a method to amplify nanograms of ccfDNA from donors to microgram quantities.

Download this poster to see how amplified ccfDNA is likely an effective analyte for concordance studies and can be manufactured in quantities and formats that should allow for investigations of underlying causes of discordance.

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