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DiaCarta Gets CE Mark for qPCR-based Mutation Detection Kits

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Molecular diagnostics startup DiaCarta said this week that it has received a CE IVD mark for several of its QClamp line of real-time PCR-based mutation detection kits.

Specifically, the company received CE marking for QClamps KRAS (including codon 146 and 117), NRAS (including codon 146), EGFR (including T790M and all deletions and insertions), BRAF, JAK2, and PIK3CA.

The mutation test kits can derive results in two hours directly from samples such as formalin-fixed paraffin-embedded tissue, fresh tissue, and blood without DNA purification, the company said. The kits can also be used on any commercially available real-time PCR machines.

All of DiaCarta's tests use xenonucleic acid (XNA) to "clamp," or silence, amplification of non-mutant DNA in heterogeneous samples, thus exclusively amplifying the target mutant DNA.

The QClamp technology is particularly suited to liquid biopsy applications to detect tumor-derived, cell-free DNA in plasma or urine, with sensitivities equivalent to or better than droplet digital PCR, the company said. Using standard real-time qPCR instrumentation, the tests can detect mutated DNA at concentrations below 0.1 percent.

The method also improves mutation detection because a SNP mismatch causes a 15- to 20-degree difference in melt temperature — a 10-fold increase over other PCR methods, the company said.

DiaCarta, based in Hayward, Calif., commercially launched its mutation detection tests for research use only in October.

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