Description
To further accelerate the validation and clinical application of liquid biopsy-based ccfDNA targeted NGS assays, SeraCare has developed the Seraseq ctDNA Complete that expands coverage of all relevant variant types (SNVs, INDELs, CNVs, and gene fusions) in a single, highly multiplexed reference sample. These new products are offered in either a purified ctDNA format or a plasma-like matrix format, all precisely quantitated by digital PCR against a single well-characterized genomic background (GM24385), and orthogonally validated with NGS technology.
This specific ctDNA Complete product has an allele frequency of 0%.
- 25 unique multiplexed variants in 16 genes, covering 12 SNVs, 7 INDELs, 3 CNVs, and 3 SVs, in purified and plasma-like matrix formats
 - 6 different allele frequencies (AF) – WT, 0.1%, 0.5%, 1%, 2.5% and 5%
 - Allows end-to-end evaluation of assay performance across the entire workflow, including pre-analytic extraction steps
 - Variants quantitated with digital PCR and orthogonally validated by NGS
 - Blends with well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
 - Manufactured within cGMP compliant, ISO 9001 and ISO 13485 certified facilities
 
| t Specifications | |
| # of Variants | 25 | 
| Allele Frequency | WT | 
| Fragment Size | ~170bp average | 
| Concentration | 25 ng/mL | 
| Volume | 5 mL | 
| Amount | 125 ng (single vial) | 
| Matrix | SeraCon Matribase (human plasma-like) | 
| NGS-Based Assay Compatibility Chart | |||||
| Archer® Reveal ctDNA 28 Kit | Oncomine® Pan-  Cancer Cell-Free Assay  | 
Oncomine Lung  cfDNA Assay  | 
Oncomine  Colon cfDNA  | 
UltraSEEK  Colon Panel  | 
UltraSEEK  Lung Panel  | 
| AKT1 | AKT1 | ALK | AKT1 | BRAF | BRAF | 
| ALK | ALK | BRAF | BRAF | EGFR | EGFR | 
| BRAF | BRAF | EGFR | EGFR | KRAS | ERBB2 | 
| EGFR | EGFR | ERBB2 | ERBB2 | NRAS | KRAS | 
| ERBB2 | ERBB2 | KRAS | KRAS | PIK3CA | PIK3CA | 
| KIT | KIT | MET | NRAS | ||
| KRAS | KRAS | NRAS | PIK3CA | ||
| MET | MET | PIK3CA | |||
| NRAS | MYC | ROS1 | |||
| PIK3CA | NRAS | ||||
| RET | PIK3CA | ||||
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 Archer® is a registered trademark, and Reveal ctDNA is a trademark of ArcherDx, Inc. 
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