SeraCare provides reference materials and tools to address challenges in precision medicine and next generation sequencing (NGS)-based assays. Their highly multiplexed reference materials allow labs to identify assay variability and design reference materials in silico. Their biomimetic materials mimic patient samples with equivalent performance and enhanced stability. Engineered cell lines mimic rare patient-derived tumor types and variants. Their products and technologies help with development, validation, production, and reporting for a variety of NGS-based assays including tumor profiling, circulating tumor and fetal DNA, and infectious and inherited disease assays. They provide full-process reference materials in various formats including FFPE tissues, synthetic plasma, and purified DNA produced using digital PCR for high accuracy.

1. Acute needs in Precision Medicine
• High complexity of data
– 10’s of thousands bases vs. 10’s of millions of bases
• Incompleteness of variant coverage
– homologous regions
– repetitive regions
– homopolymers
– copy number variants
• No minimal reporting standards

2. Our Approach
Highly multiplexed assays require
highly multiplexed reference
materials

3. SeraCare Technology Overview
TechnologyProblem SeraCare Solution
Biosynthetics
Highly multiplexed, rare
variants, precise
frequencies
“Ground Truth”
materials allow labs to
identify assay variability,
in silico design
Biomimetics
Lack of reference
materials except
remnant patient samples
Commutable, patient-like
materials with equivalent
performance and
enhanced stability
Engineered
Cell Lines
Need to mimic patient-
derived tumor types, rare
variants, full process
RNA (12) or DNA (15)
variants, FFPE

4. Select NGS Challenges Addressed by
SeraCare Products and Technologies
Development
• Rare variants
• Positive controls
Validation
• Scarcity of human materials
• Lack of ‘ground truth’ materials
to normalize performance
Production
• Performance monitoring
• Tracking and trending data
Reporting
• CAP CLIA
• Proficiency testing
SeraCare
Products and
Technology
4

5. Seraseq™ QC Data Tools
5
Tools for
NGS-based
Assays
Tumor
profiling
assays
Circulating
tumor DNA
assays
Circulating
fetal DNA
(NIPT)
Inherited
disease
assays
Infectious
disease
assays
QC Data
Informatics
/Lab
efficiency

6. Seraseq Tools for Precision Medicine
• Multiple full-process formats
– FFPE Tissues
– synthetic plasma
– purified DNA
• Flexible technologies
– Digital PCR for high quantitation accuracy
– Ability to target any percentage of mutation to wild-
type
• VariantFlex custom capability
– Custom formats, mutations, allele frequencies

7. Seraseq Tools for Precision Medicine
FFPE Format
• FFPE Tumor Fusion RNA Reference Material v1
• FFPE Tumor Reference Material v1
Plasma-like Format
• ctDNA Reference Material v1
• Trisomy 21 Reference Material v1
• Trisomy 18 Reference Material v1
• Trisomy 13 Reference Material v1
• Trisomy 21, 18 & 13 Reference Material v1
• Trisomy 21 Aneuploidy Linearity Kit Reference Material v1
• Aneuploidy Negative (Euploid) Reference Material
Purified DNA Format
• Tumor Mutation DNA Mix v2
• Tri-Level Tumor Mutation DNA Mix v1
• ctDNA Mutation Mix Kit v1
• Cardiomyopathy Mutation DNA Mix v1
• Inherited Cancer Mutation DNA Mix v1