GenVault Overview January 2005

The Problem Conventional biosample management will not meet the ensuing demand for access to genetic samples and testing.

The Products GenVault’s complete sample management solution:  Consumables – sample storage & recovery plates  Hardware – sample handling equipment  Software – sample tracking & annotation …for the storage, retrieval, recovery and distribution of biosamples.

GenVault Consumables

Porous Storage Support Media  Little upfront effort to store samples long term  Chemically treated to isolate and preserve DNA for years (14 so far) at room temperature  Optimal use of sample  Easy access to 384 independent aliquots  Store enough DNA for multiple experiments per dry aliquot (element)  Conventional shipping methods  No biohazard labeling/treatment  DNA easily extracted from elements w/ proprietary room temperature protocol GenPlate: Dry-State Storage Consumable

Permanent Sample Identification  Highly accurate sample tracking via proprietary dual sample identification  GenCodes linked to de-identified data remain with DNA at all times Barcode on each plate GenCode on each element

GenPlate Configurations

Element Recovery – Study Plate Assembly Cap Study Tube

DNA Recovery - GenSolve Wash elements Purify DNA

DNA Recovery  Semi-automated protocol  Punching and recovery station  Multi-channel pipette  1-12 Study Tubes  Automated protocol  96 tip liquid handler  1-96 Study Tubes

Element DNA Yield and Variability Quantity (ng) Concentration (ng/  l) Min440.3 Max Average1320.9

GenPlate DNA Quality  Mostly double stranded DNA  Picogreen quantitation  Large fragments (many Kb)  PCR up to 9.3Kb  PFGE shows >35Kb  Compatible with downstream applications  WGA (Qiagen (MSI), GE-Amersham, Rubicon)  Genotyping Illumina (Reproducibility >0.98) Lanes 1 and 7; 500bp ladder, Lanes 2-5 are amplicons from GenVault eluted DNA and lanes 8-11 are amplicons from Qiagen extracted DNA. Lanes 2 and 8; 110bp amplicon, Lanes 3 and 9; 558bp amplicon, Lanes 4 and 10; 1764bp amplicon and lanes 5 and 11; 1Kbp amplicon. Products were amplified using one universal PCR protocol. 5ng of dsDNA was added to each reaction. Gel is 1% agarose, run at 120V for 45 min and stained with EtBr. GenVault Eluted DNA Qiagen Extracted DNA

GenPlate vs. Qiagen via ABI Identifiler ® Left: DNA extracted from blood sample using Qiagen. Right: DNA eluted from GenVault media with same blood sample applied. DNA was then analyzed using the ABI Identifiler kit. DNA eluted from GenPlate performs as well as Qiagen extracted DNA on ABI Identifiler test.

Consumable Product Plans DNA Protein RNA Blood, Buccal, Buffy, Tissue Blood, Tissue Tissue Clones Bacterial

Next Year: Protein Plate

 80% of immunoassays “work” in dry state  70% show signal increase relative to frozen  Evaluating on other platforms (MS)

Future: GenPlate for Paraffin Tissue Samples 307M tissue samples are archived in the US, growing at an annual rate of 20M samples (RAND, 2004)  Feasibility established at M.D. Anderson and VA Hospital  Direct thermal extraction of DNA  Direct transfer of fluidized DNA to GenPlate  Room temperature storage  Greater than 75% recovery  Supports: PCR up to 500bp, WGA (Rubicon), Microsatellites (ABI Identifiler)  Early genotyping results (Illumina)

GenVault Storage Hardware

Storage Handling Equipment  Highly scalable (1K – millions plates)  Highest throughput (300 plates/hr)  Highest density (800+ plates/sq. ft.)  Smallest footprint (450 vs. 20K sq. ft.)  Low operating costs (room temp)  Installed in fireproof vault (class 125)  Multi-applications (DNA, proteins, …)  Built by experienced ASRS provider  Industrial quality for 24/7 operation

GV Series – Personal Archive Capacity990 GenPlates Footprint81”H x 98”W x 30”D Viewing and access Three clear, locking cabinet doors Power requirements Standard 120V PortabilityWheels allow for easy relocations SoftwareWindows XP, 2000 compatible ComputerDesktop computer and accessories included Barcode scannerIncluded, reads GenPlate barcodes Air filtration0.3 micron HEPA filter

GV Series – Dynamic Archive Input and Output Stackers GV-100 – 400,000 plate capacity

GenVault Software

GenVault Software Architecture

Advanced Informatics  Easy access  Web browser and Java client access  Flexible annotation  XML-based data element definitions  Easy integration  Web services engine / SOAP API to integrate with existing LIMS  Networkable and easy expansion  Seamless integration of multiple archives

Advanced Informatics  Role and study based authorization  Multiple roles and multiple study permissions  Secure authentication  128-bit encryption  Audit trails  Record all transactions by authenticated users  Advanced workflow  Ability to model lab processes and enforce steps

The GenVault Integrated Solution GenVault’s complete sample management solution:  Consumables – sample storage & recovery plates  Hardware – sample handling equipment  Software – sample tracking & annotation …for the storage, retrieval, recovery and distribution of biosamples.

GenVault Enables a Multi-User Environment Site 1 Site 3 Site 2 Site N GenVault Dynamic Archive Site 3

GenVault Features and Benefits  Room temperature storage and processing Cost effective alternative to cryogenic storage  Optimal use of sample Enables ongoing sample use with hundreds of aliquots  Tamper proof sample identification Reliable chain of custody  Streamlined, automated DNA extraction, aliquoting and storage No upfront sample processing before storage Immediately ready for downstream analysis

GenVault Features and Benefits  High quality DNA ready for analysis Less DNA required for assays  Conventional shipping, biohazard free Operational cost advantage  Secure, accurate, high-speed access and retrieval Eliminates human error Reduces labor requirements  Custom, scalable design

GenVault Corporation 2101 Faraday Avenue Carlsbad, CA (760) (760) fax Contact Information

GenPort  GenVault’s GV-100 Dynamic Archive  IRB-approved and GLP certified  Access and retrieve samples and data with web-based interface  Safe, secure and reliable storage  Fast retrieval and distribution of samples to multiple locations  Low shipping costs