Gen. Vault Overview January 2005
The Problem Conventional biosample management will not meet the ensuing demand for access to genetic samples and testing.
The Products Gen. Vault’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.
Gen. Vault Consumables
Gen. Plate: Dry-State Storage Consumable 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
Permanent Sample Identification Barcode on each plate Highly accurate sample tracking via proprietary dual sample identification Gen. Codes linked to de-identified data remain with DNA at all times Gen. Code on each element
Gen. Plate Configurations
Element Recovery – Study Plate Assembly Cap Study Tube
DNA Recovery - Gen. Solve 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) Min 44 0. 3 Max 350 2. 3 Average 132 0. 9
Gen. Plate DNA Quality § Mostly double stranded DNA Picogreen quantitation § Large fragments (many Kb) PCR up to 9. 3 Kb PFGE shows >35 Kb § Compatible with downstream applications WGA (Qiagen (MSI), GE-Amersham, Rubicon) Genotyping n Illumina (Reproducibility >0. 98) Gen. Vault Eluted DNA Qiagen Extracted DNA Lanes 1 and 7; 500 bp ladder, Lanes 2 -5 are amplicons from Gen. Vault eluted DNA and lanes 8 -11 are amplicons from Qiagen extracted DNA. Lanes 2 and 8; 110 bp amplicon, Lanes 3 and 9; 558 bp amplicon, Lanes 4 and 10; 1764 bp amplicon and lanes 5 and 11; 1 Kbp amplicon. Products were amplified using one universal PCR protocol. 5 ng of ds. DNA was added to each reaction. Gel is 1% agarose, run at 120 V for 45 min and stained with Et. Br.
Gen. Plate vs. Qiagen via ABI Identifiler® Left: DNA extracted from blood sample using Qiagen. Right: DNA eluted from Gen. Vault media with same blood sample applied. DNA was then analyzed using the ABI Identifiler kit. DNA eluted from Gen. Plate performs as well as Qiagen extracted DNA on ABI Identifiler test.
Consumable Product Plans DNA Blood, Buccal, Buffy, Tissue Clones Bacterial Protein Blood, Tissue RNA 2004 2005 2006 Tissue
Next Year: Protein Plate
Next Year: Protein Plate § 80% of immunoassays “work” in dry state § 70% show signal increase relative to frozen § Evaluating on other platforms (MS)
Future: Gen. Plate for Paraffin Tissue Samples 307 M tissue samples are archived in the US, growing at an annual rate of 20 M samples (RAND, 2004) Feasibility established at M. D. Anderson and VA Hospital Direct thermal extraction of DNA Direct transfer of fluidized DNA to Gen. Plate Room temperature storage Greater than 75% recovery Supports: PCR up to 500 bp, WGA (Rubicon), Microsatellites (ABI Identifiler) Early genotyping results (Illumina)
Gen. Vault Storage Hardware
Storage Handling Equipment § Highly scalable (1 K – millions plates) § Highest throughput (300 plates/hr) § Highest density (800+ plates/sq. ft. ) § Smallest footprint (450 vs. 20 K 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 Capacity 990 Gen. Plates Footprint 81”H x 98”W x 30”D Viewing and access Three clear, locking cabinet doors Power requirements Standard 120 V Portability Wheels allow for easy relocations Software Windows XP, 2000 compatible Computer Desktop computer and accessories included Barcode scanner Included, reads Gen. Plate barcodes Air filtration 0. 3 micron HEPA filter
GV Series – Dynamic Archive Input and Output Stackers GV-100 – 400, 000 plate capacity
Gen. Vault Software
Gen. Vault 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 Gen. Vault Integrated Solution Gen. Vault’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.
Gen. Vault Enables a Multi-User Environment Site 1 Site 3 3 Gen. Vault Dynamic Archive Site 2 Site N
Gen. Vault Features and Benefits Room temperature storage and processing n Cost effective alternative to cryogenic storage Optimal use of sample n Enables ongoing sample use with hundreds of aliquots Tamper proof sample identification n Reliable chain of custody Streamlined, automated DNA extraction, aliquoting and storage n n No upfront sample processing before storage Immediately ready for downstream analysis
Gen. Vault Features and Benefits High quality DNA ready for analysis n Less DNA required for assays Conventional shipping, biohazard free n Operational cost advantage Secure, accurate, high-speed access and retrieval n n Eliminates human error Reduces labor requirements Custom, scalable design
Contact Information Gen. Vault Corporation 2101 Faraday Avenue Carlsbad, CA 92008 (760) 268 -5200 (760) 268 -5201 fax www. Gen. Vault. com
Gen. Port § Gen. Vault’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
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