Seraseq® NGS Reference Materials
Ground-Truth Standards for Molecular Assurance
Seraseq® NGS reference materials give clinical and translational laboratories a ground-truth standard for developing, validating and monitoring next-generation sequencing assays. This comprehensive, platform-agnostic suite of patient-like reference materials accelerates development, streamlines validation, and builds confidence in the results of today's demanding clinical genomics assays.
Replicating Real Patient Biopsies
Because Seraseq products are engineered from well-characterised cell lines and biosynthetic DNA/RNA targets, they can be handled in an identical fashion to a patient sample. This consistency spans the complete analytical process—from nucleic-acid extraction and quantitation, through library construction and sequencing, to final bioinformatic data analysis.
- Primary Platforms: Next-Generation Sequencing (NGS), Sanger Sequencing
- Downstream Molecular Technologies: Real-time PCR, digital PCR (dPCR), and Microarray workflows
- Manufacturing Standards: Produced under cGMP-compliant conditions inside ISO 13485-certified facilities to ensure robust lot-to-lot consistency.
- For Research Use Only. Not for use in diagnostic procedures.
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Built for confident NGS assay development
All variant types
Ready-to-use materials covering clinically relevant SNVs, indels, CNVs and RNA fusions.
Highly multiplexed
More data per NGS run, reducing sequencing cost while broadening coverage.
Multiple formats
Purified DNA & RNA, ctDNA, encapsulated ctDNA in plasma, and FFPE to match your workflow.
cGMP & ISO 13485
Manufactured under stringent quality systems for lot-to-lot consistency.
dPCR-qualified
Every allele frequency and copy number verified by digital PCR at release.
Regulatory-recognised
Accepted by major reference regulatory testing boards to establish baseline analytical validation.
The technology
Innovative, patient-like biosynthetic design
SeraCare engineers biosynthetic DNA/RNA targets and well-characterised cell lines, then blends them with a single, well-characterised background (GM24385) at the required allele frequency. Digital PCR precisely modulates and controls each level, so you get scalable, flexible and commutable reference standards for a wide range of targeted panels — in both DNA and RNA formats.
Full-process control
Handled just like a patient sample
Stable circulating cell-free DNA in synthetic plasma-like material and FFPE cell lines let Seraseq products monitor your entire workflow — not only the sequencer. Use them across nucleic-acid extraction, quantitation, NGS library construction, template preparation, sequencing and data analysis to pinpoint exactly where variability enters your assay.
Clinical applications
Find your reference materials
Somatic Cancer / Oncology
112 references — solid tumour, heme/myeloid, immuno-oncology (TMB, MSI, HRD) and liquid biopsy (ctDNA).
Reproductive Health
31 references — NIPT trisomies, microdeletions, sex-chromosome aneuploidies and PGT-A.
Need help selecting?
Match the right reference material to your assay
From limit-of-detection studies to complex genomic signatures, our Life Sciences specialists help you choose the right Seraseq format, allele frequency and variant set — or scope a custom solution.
- PATIENT-LIKE REFERENCE MATERIALS
- HIGHLY MULTIPLEXED
- dPCR-QUALIFIED VARIANTS
- cGMP / ISO 13485 MANUFACTURED
- FULL-PROCESS QC
- PATIENT-LIKE REFERENCE MATERIALS
- HIGHLY MULTIPLEXED
- dPCR-QUALIFIED VARIANTS
- cGMP / ISO 13485 MANUFACTURED
- FULL-PROCESS QC
Ordering Information
Somatic Cancer / Oncology
| Highly multiplexed genomic DNA blends designed to validate somatic variant calling across hot-spot mutation panels. | ||
| Article Number | Description | Package Insert Link |
| 0710-0094 | Seraseq Tumor Mut DNA Mix v2 AF10 HC | 0710-0094 |
| 0710-0095 | Seraseq Tumor Mut DNA Mix v2 AF7 HC | 0710-0095 |
| 0710-0097 | Seraseq Tri-Lvl Tumor Mut DNA Mix v2 HC | 0710-0097 |
| 0710-3460 | Seraseq Tumor Mutation DNA Mix v3 AF10% | 0710-3460 |
| 0710-3461 | Seraseq Tumor Mutation DNA Mix v3 AF7% | 0710-3461 |
| 0710-3462 | Seraseq Tumor Mut DNA Mix v3 Tri-Level | 0710-3462 |
| Multiplexed fragmentated DNA standards engineered to mimic circulating tumor DNA profiles for liquid biopsy assay optimization. | ||
| Article Number | Description | Package Insert Link |
| 0710-0139 | Seraseq ctDNA Mutation Mix v2 AF2% | 0710-0139 |
| 0710-0140 | Seraseq ctDNA Mutation Mix v2 AF1% | 0710-0140 |
| 0710-0141 | Seraseq ctDNA Mutation Mix v2 AF0.5% | 0710-0141 |
| 0710-0142 | Seraseq ctDNA Mutation Mix v2 AF0.25% | 0710-0142 |
| 0710-0143 | Seraseq ctDNA Mutation Mix v2 AF0.13% | 0710-0143 |
| 0710-0144 | Seraseq ctDNA Mutation Mix v2 WT | 0710-0144 |
| 0710-3097 | Seraseq ctDNA Mutation Mix v4 AF0.1% | 0710-3097 |
| 0710-3099 | Seraseq ctDNA Mutation Mix v4 AF0.5% | 0710-3099 |
| 0710-3100 | Seraseq ctDNA Mutation Mix v4 AF5% | 0710-3100 |
| 0710-3101 | Seraseq ctDNA Mutation Mix v4 WT | 0710-3101 |
| Full-process, fragmented circulating cell-free DNA structures for evaluating analytical sensitivity at low variant allele frequencies. | ||
| Article Number | Description | Package Insert Link |
| 0710-0203 | Seraseq ctDNA Ref Material v2 AF2% | 0710-0203 |
| 0710-0204 | Seraseq ctDNA Ref Material v2 AF1% | 0710-0204 |
| 0710-0205 | Seraseq ctDNA Ref Material v2 AF0.5% | 0710-0205 |
| 0710-0207 | Seraseq ctDNA Ref Material v2 AF0.125% | 0710-0207 |
| 0710-0208 | Seraseq ctDNA Ref Material v2 WT | 0710-0208 |
| 0710-3989 | Seraseq ctDNA Reference Material v4 WT | 0710-3989 |
| 0710-3990 | Seraseq ctDNA Reference Material v4 AF5% | 0710-3990 |
| 0710-3991 | Seraseq ctDNA Reference Material v4 AF0.5% | 0710-3991 |
| 0710-3992 | Seraseq ctDNA Reference Material v4 AF0.1% | 0710-3992 |
| Artificially modified and fragmented nucleosomal structures used to simulate degraded plasma specimens for stress-testing assay limits. | ||
| Article Number | Description | Package Insert Link |
| 0710-0528 | Seraseq ctDNA Comp Mut Mix AF 5% | 0710-0528 |
| 0710-0529 | Seraseq ctDNA Comp Mut Mix AF 2.5% | 0710-0529 |
| 0710-0530 | Seraseq ctDNA Comp Mut Mix AF 1% | 0710-0530 |
| 0710-0531 | Seraseq ctDNA Comp Mut Mix AF 0.5% | 0710-0531 |
| 0710-0532 | Seraseq ctDNA Comp Mut Mix AF 0.1% | 0710-0532 |
| 0710-0533 | Seraseq ctDNA Comp Mut Mix WT | 0710-0533 |
| 0710-0669 | Seraseq ctDNA Comp Ref Material AF5% | 0710-0669 |
| 0710-0670 | Seraseq ctDNA Comp Ref Material AF2.5% | 0710-0670 |
| 0710-0671 | Seraseq ctDNA Comp Ref Material AF1% | 0710-0671 |
| 0710-0672 | Seraseq ctDNA Comp Ref Material AF0.5% | 0710-0672 |
| 0710-0673 | Seraseq ctDNA Comp Ref Material AF0.1% | 0710-0673 |
| 0710-0674 | Seraseq ctDNA Comp Ref Material WT | 0710-0674 |
| Ultra-low variant frequency reference points explicitly calibrated to optimize and validate Minimal Residual Disease (MRD) tracks. | ||
| Article Number | Description | Package Insert Link |
| 0710-2146 | ctDNA MRD Panel Mix | 0710-2146 |
| 0710-3670 | Seraseq ctDNA MRD 0% Tumor | 0710-3670 |
| 0710-3671 | Seraseq ctDNA MRD 0.5% Tumor | 0710-3671 |
| 0710-3672 | Seraseq ctDNA MRD 0.05% Tumor | 0710-3672 |
| 0710-3673 | Seraseq ctDNA MRD 0.005% Tumor | 0710-3673 |
| Targeted blood-derived cancer profiles matching translocation and hotspot variants key to hematological sequencing workflows. | ||
| Article Number | Description | Package Insert Link |
| 0710-2646 | Seraseq ctDNA Myeloid Mix, 0% (WT) | 0710-2646 |
| 0710-2647 | Seraseq ctDNA Myeloid Mix, AF0.1% | 0710-2647 |
| 0710-2648 | Seraseq ctDNA Myeloid Mix, AF0.5% | 0710-2648 |
| 0710-2649 | Seraseq ctDNA Myeloid Mix, AF1% | 0710-2649 |
| Liquid biopsy standards engineered with targeted structural and single-nucleotide alterations characteristic of non-Hodgkin lymphomas. | ||
| Article Number | Description | Package Insert Link |
| 0710-3181 | Seraseq ctDNA Lymphoma Mix WT | 0710-3181 |
| 0710-3182 | Seraseq ctDNA Lymphoma Mix AF1% | 0710-3182 |
| 0710-3183 | Seraseq ctDNA Lymphoma Mix AF0.5% | 0710-3183 |
| 0710-3184 | Seraseq ctDNA Lymphoma Mix AF0.1% | 0710-3184 |
| Multiplexed liquid biopsy standards configured with actionable variant markers for monitoring advanced prostate cancer indications. | ||
| Article Number | Description | Package Insert Link |
| 0710-3327 | Seraseq ctDNA Prostate Mix WT | 0710-3327 |
| 0710-3328 | Seraseq ctDNA Prostate Mix AF1% | 0710-3328 |
| 0710-3329 | Seraseq ctDNA Prostate Mix AF0.5% | 0710-3329 |
| Varying concentrations of cell-free fragments in plasma to assess and normalize the efficiency of automated nucleic acid isolation machinery. | ||
| Article Number | Description | Package Insert Link |
| 0710-3294 | Seraseq ctDNA Extraction RM 20ng/mL | 0710-3294 |
| 0710-3295 | Seraseq ctDNA Extraction RM 50ng/mL | 0710-3295 |
| 0710-3296 | Seraseq ctDNA Extraction RM 80ng/mL | 0710-3296 |
| Genomic DNA structures presenting quantified amplification stages of key driver oncogenes to validate diagnostic copy number determinations. | ||
| Article Number | Description | Package Insert Link |
| 0710-0411 | SeraSeq Breast CNV Mix, +3 copies | 0710-0411 |
| 0710-0412 | SeraSeq Breast CNV Mix, +6 copies | 0710-0412 |
| 0710-0413 | SeraSeq Breast CNV Mix, +12 copies | 0710-0413 |
| 0710-0414 | SeraSeq Lung & Brain CNV Mix, +3 copies | 0710-0414 |
| 0710-0415 | SeraSeq Lung & Brain CNV Mix, +6 Copies | 0710-0415 |
| 0710-0416 | SeraSeq Lung & Brain CNV Mix, +12 Copies | 0710-0416 |
| 0710-2865 | Seraseq FFPE Solid Tumor CNV RM | 0710-2865 |
| 0710-2866 | Seraseq Solid Tumor CNV Mix +3 copies | 0710-2866 |
| 0710-2867 | Seraseq Solid Tumor CNV Mix +6 copies | 0710-2867 |
| 0710-2868 | Seraseq Solid Tumor CNV Mix +12 copies | 0710-2868 |
| 0710-4109 | Seraseq CNV Copy Loss DNA Mix | 0710-4109 |
| These reference materials provide stable, cell-line derived standards carrying exome-wide, dPCR-vetted mutations. They are engineered to calibrate and stabilize bioinformatics pipelines generating complex TMB somatic mutation metrics across both purified genomic DNA and FFPE preparation layers, mitigating workflow bias. | ||
| Article Number | Description | Package Insert Link |
| 0710-1307 | Seraseq FFPE TMB RM Score 26 | 0710-1307 |
| 0710-1308 | Seraseq FFPE TMB RM Score 9 | 0710-1308 |
| 0710-1309 | Seraseq FFPE TMB RM Score 20 | 0710-1309 |
| 0710-1310 | Seraseq FFPE TMB RM Score 7 | 0710-1310 |
| 0710-1323 | Seraseq gDNA TMB Mix Score 26 | 0710-1323 |
| 0710-1324 | Seraseq gDNA TMB Mix Score 20 | 0710-1324 |
| 0710-1325 | Seraseq gDNA TMB Mix Score 9 | 0710-1325 |
| 0710-1326 | Seraseq gDNA TMB Mix Score 7 | 0710-1326 |
| 0710-1586 | Seraseq gDNA TMB Mix Score 13 | 0710-1586 |
| 0710-1618 | Seraseq FFPE TMB RM Score 13 | 0710-1618 |
| 0710-2087 | Seraseq Blood TMB Mix Score 7 | 0710-2087 |
| 0710-2088 | Seraseq Blood TMB Mix Score 13 | 0710-2088 |
| 0710-2089 | Seraseq Blood TMB Mix Score 20 | 0710-2089 |
| 0710-2090 | Seraseq Blood TMB Mix Score 26 | 0710-2090 |
| 0710-2463 | Seraseq gDNA TMB Reference Panel Mix | 0710-2463 |
| Reference standards containing specific configurations of short mononucleotide repeat tracks to assess assay proficiency in parsing micro-deletions. | ||
| Article Number | Description | Package Insert Link |
| 0710-1670 | Seraseq gDNA MSI-High Mix | 0710-1670 |
| 0710-1675 | Seraseq MSI Reference Panel Mix AF5 | 0710-1675 |
| 0710-1676 | Seraseq MSI Ref Panel Mix AF20 | 0710-1676 |
| 0710-2236 | Seraseq FFPE MSI-High RM | 0710-2236 |
| Complex cellular genomic materials displaying trace evidence of genomic instability, designed to standardize HRD scoring algorithms. | ||
| Article Number | Description | Package Insert Link |
| 0710-2643 | Seraseq FFPE HRD High-Pos RM | 0710-2643 |
| 0710-2644 | Seraseq FFPE HRD Negative RM | 0710-2644 |
| 0710-2645 | Seraseq FFPE HRD Low-Pos RM | 0710-2645 |
| 0710-2879 | Seraseq gDNA HRD High-Positive Mix | 0710-2879 |
| 0710-2880 | Seraseq gDNA HRD Low-Positive Mix | 0710-2880 |
| 0710-2881 | Seraseq gDNA HRD Negative Mix | 0710-2881 |
| This highly targeted multiplex RNA standard consolidates rare, clinically impactful translocation variants critical to sarcoma oncology classifications. It functions as a platform-agnostic control to optimize fusion splicing detection and alignment algorithms across extensive RNA sequencing panels. | ||
| Article Number | Description | Package Insert Link |
| 0710-3809 | Seraseq Sarcoma Plus RNA Fusion Mix | 0710-3809 |
| Stabilized, fragmented cell-free RNA matrices designed to validate structural driver fusion detections directly from circulating fluid profiles. | ||
| Article Number | Description | Package Insert Link |
| 0710-4078 | Seraseq cfRNA Fusion Mix | 0710-4078 |
| Fixed structural cellular models ensuring accurate cross-linking and processing simulation during diagnostic protocol verification. | ||
| Article Number | Description | Package Insert Link |
| 0710-3634 | Seraseq Solid Tumor FFPE DNA RM | 0710-3634 |
| Intentionally heat-altered or partially degraded embedded cellular samples to model difficult real-world archival block processing profiles. | ||
| Article Number | Description | Package Insert Link |
| 0710-1492 | Compromised FFPE Tumor DNA RM | 0710-1492 |
| Purified, non-mutated Total Nucleic Acid (TNA) configurations delivering clean negative-baseline parameters for broad molecular assays. | ||
| Article Number | Description | Package Insert Link |
| 0710-1580 | Seraseq TNA Wild Type Mix | 0710-1580 |
| A high-diversity multiplex transcript mixture optimized to track linear coverage metrics and call rates across exhaustive discovery workflows. | ||
| Article Number | Description | Package Insert Link |
| 0710-2129 | Seraseq Whole Transcriptome RNA Seq Mix | 0710-2129 |
Ordering Information
Reproductive Health
| Article Number | Description | Package Insert Link |
| 0720-0167 | Seraseq T21 Male Matched RM | 0720-0167 |
| 0720-0168 | Seraseq T21 Female Matched RM | 0720-0168 |
| 0720-0169 | Seraseq Euploid Male Matched RM | 0720-0169 |
| 0720-0170 | Seraseq Euploid Female Matched RM | 0720-0170 |
| 0720-0171 | Seraseq T18 Male Matched RM | 0720-0171 |
| 0720-0172 | Seraseq T18 Female Matched RM | 0720-0172 |
| 0720-0173 | Seraseq 22q11 Male Matched RM | 0720-0173 |
| 0720-0174 | Seraseq 22q11 Female Matched RM | 0720-0174 |
| 0720-0779 | Seraseq T13 Male Matched RM | 0720-0779 |
| 0720-0780 | Seraseq T13 Female Matched RM | 0720-0780 |
| 0720-0952 | Seraseq Turner Syn (XO) Ref Mat | 0720-0952 |
| 0720-0953 | Seraseq Klinefelter Syn (XXY) Ref Mat | 0720-0953 |
| 0720-0954 | Seraseq Jacobs Syn (XYY) Ref Mat | 0720-0954 |
| 0720-1069 | Seraseq Triple X Syndrome Ref. Material | 0720-1069 |
| 0720-1100 | Seraseq Antepartum T21 Male cfDNA | 0720-1100 |
| 0720-1101 | Seraseq Postpartum T21 Male cfDNA | 0720-1101 |
| 0720-1102 | Seraseq Antepartum 22q11 Male cfDNA | 0720-1102 |
| 0720-1103 | Seraseq Postpartum 22q11 Male cfDNA | 0720-1103 |
| 0720-1115 | Seraseq Antepartum SMA Male cfDNA | 0720-1115 |
| 0720-1116 | Seraseq 22q11 Male Twins Matched cfDNA | 0720-1116 |
| 0720-1117 | Seraseq Euploid Male Twins Matched cfDNA | 0720-1117 |
| 0720-1136 | Seraseq Euploid Female RM Lyophilized | 0720-1136 |
| 0720-1137 | Seraseq T21 Male RM Lyophilized | 0720-1137 |
| 0720-1138 | Seraseq T18 Female RM Lyophilized | 0720-1138 |
Ordering Information
Inherited Disease
Frequently Asked Questions
Key information on Seraseq NGS reference materials, formats and use.
Seraseq NGS reference materials are labelled For Research Use Only (not for use in diagnostic procedures), and are widely used for analytical development and validation of clinical NGS assays. Major international validation departments consistently accept them within technical file dossiers.
Purified DNA and RNA, circulating tumour DNA (ctDNA), encapsulated ctDNA in synthetic plasma, and FFPE — so you can mirror your real sample type end to end.
Each reference material carries many clinically relevant variants at once, giving significantly more data per NGS run and reducing the number of controls and sequencing cost.
Every variant is qualified by digital PCR (dPCR) as the gold-standard release test, so the stated allele frequency or copy number is precise and traceable.
Yes. SeraCare offers expert-designed bespoke reference materials with customised allele frequency, format, variant type and matrix, drawing on a library of >400 clinically actionable variants.
Each product's package insert is available directly on its corresponding row in the catalog matrices above.