The Seraseq Tumor Mutation DNA Mix v2 (RUO-GMP) and Seraseq FFPE Tumor KRAS Reference Material Kit are claimed to be accurate, precise and consistent materials and can help laboratories in determining the performance of their clinical oncology assays.

SeraCare says that detecting cancer-relevant mutations with the help of technologies such as NGS or qPCR can be challenging for various reasons.

The presence of variant at allele frequencies approaching lower limit of detection (LoD), variation that affects results can be difficult to trace and often arises across complex workflows.

Assays can have different levels of sensitivities across different types of mutations. Along with this, using residual patient samples or cell lines that are positive for single mutation as reference materials may not be cost effective for highly multiplexed assays which can detect many biomarkers in a single run.

According to SeraCare, the Seraseq Tumor Mutation DNA Mix v2 has 40 clinically actionable and analytically challenging mutations at 10%, 7% and 4% Minor Allele Frequency (MAF). The company says that it has been produced with good manufacturing practices (GMP) to ensure consistency between lots.

The multiplexed material contains challenging and relevant variant types in a reference material on the market, which includes structural variants with defined intronic breakpoints, insertion/deletion mutations and variants present in repetitive sequence contexts.

It is available in a Tri-Level format, where the 40 mutations are distributed across three MAFs, in a single vial.

On the other hand, the Seraseq FFPE Tumor KRAS Reference Material Kit v1 has 7 mutations affecting codons 12 and 13 of the KRAS gene, which account for about 97% of all characterized KRAS mutation subtypes. All the variants are present at about 5% MAF in order to rigorously challenge the LoD for common and commercially available KRAS tests.

SeraCare chief scientific officer Russell Garlick said: "We are very pleased to introduce these new reference materials to our partners and customers who are developing, validating, and running clinical oncology molecular tests. 

"Along with our other Seraseq reference materials as well as our iQ NGS QC Management software solution, they will help ensure laboratories are able to focus on their patients, and can implement a highly effective, cost-efficient QC strategy."