RapidHIT™ 200
Integrated Sample-to-profile System
Keith Elliott
May 2012
Overview
1. Introduction to IntegenX
2. Overview of the RapidHIT™ 200
3. Poweplex® 16 Data from prototypes
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Overview
Who We Are
Founded in 2003, Pleasanton, CA
Solutions oriented, growth-stage company
Next Generation Sequencing products
RapidHIT 200 Pre-Production Units – Q2 2012
Company
Over 125 employees in Pleasanton, CA & UK sales office
R&D, engineering, scientific, microfabrication
Operations, instrument and reagent manufacturing
Sales, marketing, support, world-wide distributors
Funding: over $100M in grants, contracts and venture capital
Strong IP position with patents, licenses and supply agreements
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Product Solutions
Rapid Human Identification – RapidHIT™ 200
Need Rapid answers for DNA human identification for defense, law
enforcement, IQ, and DHS agencies
Solution Sample-to-answer in less than 90 min
Next-Gen Sequencing Library Preparation – Apollo™ 324
Need
Solution
Human error and lack of platform flexibility in DNA and RNA
sequencing prep
Walk-away automation that serves multiple sequencing
platforms
Room Temperature Stabilization and Storage – GenPlate™ and GenTegra™
Need
Eliminate -80oC and cold chain
Solution Inorganic stabilization and protection
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RapidHIT 200
Rapid human identification system
May 2012
Rapid Human Identification: RapidHIT 200
The traditional HID process can take days to months:
In
Out
Swabs
Blood
Saliva
Etc.
DNA
Identity
Results in <90 minutes
Sample in, profile out
Minimal training required
Point-of-action solution
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RapidHIT™ 200: The Complete HID Solution
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RapidHIT™ 200: The Complete HID Solution
•
Input: Up to 8 swabs, buccal swabs, blood,
other liquids, lysates or sample types
•
Output: xml data file or query of on-board or
remote databases
•
Cartridge-based operation and consumables
Sample cartridge +/- Control cartridge
Anode cartridge
Buffer cartridge
Patent pending
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RapidHIT 200 Modular Design with Field Replaceable Modules
2. Capillary Plate
Module
3. Optics Module
1) Sample Cartridge Interface
Module and Sample cartridge
High Voltage
Module
1. Sample
Processing
2. Separations
3. Detection
4. Analysis
2. Anode
Module and
cartridge
Patent pending
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2. Buffer
Module and
cartridge
IntegenX Sample Cartridges
Disposable single use cartridges with on-board reagent
storage that integrate the HID sample preparation workflow
Performs all of the fluidic sample preparation operations
• Lyses cells, extracts and purifies DNA, multiplex PCR
amplification, addition of size standard, and injection
• Microscale On-chip Valves (MOVe™), licensed exclusively
from UC Berkeley, integrate fluidics
• STR reagents: license and supply agreement with Promega
Patent pending
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Cartridge Operation
MOVe lysis solution to swabs
Patent pending
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Cartridge Operation
MOVe lysate to beads
Patent pending
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Cartridge Operation
Capture DNA onto beads,
mix, and wash twice
Patent pending
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The DNA IQ™ System
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Consistent Yields with DNA IQ
™


DNA Bound

Databasing Applications
Small Sample
Casework

Sample Added
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Cartridge Operation
MOVe beads to
cycling region
Patent pending
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Cartridge Operation
Fill with premix
Patent pending
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Cartridge Operation
Thermocycle
Patent pending
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Cartridge Operation
MOVe STR amplicons and
dilute with size standard
Patent pending
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Cartridge Operation
MOVe STR samples to
inject into capillary array
electrophoresis
Patent pending
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Automated Identification Answers
SoftGenetics Genotyping Software
IXI TraceAnalyzer Software
Sizing and Bin Calibration
Raw Data
TraceAnalyzer
Processed
Allele Assignment + Quality Rules
Ladder
Database
Query
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Allele Table (CSV, Q Values)
RDIS/
CODIS (XML)
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RapidHIT™ 200 Pre-Production data
Sample 60M Buccal Swab
Capillaries 2 and 6
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02-29-2012
RapidHIT ™ 200 Pre-Production Unit 4
02-29-2012
Heterozygous peak balance
Sample
Sample
Cap2: 60M Buccal
Cap6: 60M Buccal
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Alleles
Pk Ht (rfu)
Pk Ht (rfu)
PHR(%)
Alleles
Pk Ht (rfu)
Pk Ht (rfu)
PHR(%)
D3S1358
17,17
100882
n/a
n/a
D3S1358
17,17
110501
n/a
n/a
THO1
6,7
13284
15819
84.0%
THO1
6,7
16201
21311
76.0%
D21S11
28,30
42017
37641
89.6%
D21S11
28,30
44578
48880
91.2%
D18S51
13,14
59075
54996
93.1%
D18S51
13,14
61880
61370
99.2%
PentaE
7,10
32751
32799
99.9%
PentaE
7,10
34899
30145
86.4%
D5S818
12,12
137731
n/a
n/a
D5S818
12,12
144917
n/a
n/a
D13S17
9,13
45463
40397
88.9%
D13S17
9,13
53851
68.4%
D7S820
10,11
56523
44707
79.1%
D7S820
10,11
83%
36820
48710
46579
95.6%
D16S539
8,12
29209
23011
78.8%
D16S539
8,12
18606
27570
67.5%
CSF1PO
10,12
30609
38897
78.7%
CSF1PO
10,12
29716
29261
98.5%
PentaD
11,13
35174
30636
87.1%
PentaD
11,13
46835
28881
61.7%
Amel
X,Y
37292
33314
89.3%
Amel
X,Y
36597
40877
89.5%
vWA
15,18
19084
21006
90.9%
vWA
15,18
27689
20669
74.6%
D8S1179
13,13
49611
n/a
n/a
D8S1179
13,13
54902
n/a
n/a
TPOX
9,10
6724
5765
85.7%
TPOX
9,10
6230
6932
89.9%
FGA
19,19
19350
n/a
n/a
FGA
19,19
15718
n/a
n/a
87%
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Comparison of profile morphology
02-29-2012
RapidHIT
3130
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Comparison of profile morphology
3130
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02-29-2012
RapidHIT
Early data on more challenging samples
Samples generated by early trial customer
Intended application is in-field covert recovery of samples for ID
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RapidHIT 200 Prototype Data
01-30-2012
BandAid
64,364
51,561
29,404
31,682
19,100
10,469
86,276
74,634
73,891
42,038
18,341
26,140
36,034
13,012
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and Proprietary
IntegenX/Proprietary
andConfidential
Confidential
9,933
12,168
30,847
RapidHIT 200 Prototype Data
Hair
Has possible contamination
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and Proprietary
IntegenX/Proprietary
andConfidential
Confidential
01-30-2012
RapidHIT 200 Prototype Data
Stub
Some adhesives affect amplification
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and Proprietary
IntegenX/Proprietary
andConfidential
Confidential
01-30-2012
RapidHIT 200 Prototype Data
Cigarette
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02-01-2012
Summary
o Provisional data only
o Profile quality
o Reproducibility
o Sensitivity
o Detailed customer trials have just started
o
o
o
o
Trials in progress/planned:
6 groups is US
2 in Europe
1 in Australasia
o European reagents (Powerplex® ESI17): Autumn 2012
o Launch events: Summer/Autumn 2012:
o UK (Key Forensic Services) June 2012
o EAFS (Hague) August 2012
o US events- Autumn 2012
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May 2012