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Headquartered in Vista, CA
FDA QSR/ISO 13485/CMDCAS Certified
Experienced Management Team
FDA 510(k) cleared products, 22 CE marked products
In house - Reagent & Analyzer R&D & Manufacturing
Hotline, Technical Support & Field Service Staff in house
>200 Instruments in Global Market
Microarray
BioInformatics
Sample
handler
AutoGenomics
Scanning
Fluidics
Hybridization
INFINITI Analyzer
Load N Go Automation
Integrates DNA & Protein analysis
into one Analyzer
Improves Lab workflow efficiency
Vendor
TEST PROCESSING
Amplification
Purified
DNA
PSS
RESULTS
Tabulated
Amplified
Sample
Eppendorf
Hands on Time
< 5 min
< 5 min
Process Time
~ 20 min
~ 85 min
AutoGenomics
< 5 min
210 min
< 15 min
315 min
Process
Automation
BioFilmChip Microarray
Software
Scheduler
BioFilmChip Microarray
Surfactant layer
Linker layer
Coated Film
Film roll
Film chip
Arrays spotted
With Oligos
BioFilmChip
Microarray
Magazine with
12 BioFilmChips
10
11
12
13
14
Reg
16
17
31
32
18
19
20
21
22
23
24
25
26
27
33
34
35
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39
40
41
42
16
46
47
48
76
91
106
121
136
151
166
181
196
28
29
30
43
44
45
59
60
16
49
50
51
52
53
54
55
56
57
89
61
15
Reg
58
10
62
63
64
65
31
87
13
70
66
67
68
69
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71
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72
14
97
32
77
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89
29
86
12
65
14
15
18
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20
81
15
99
33
92
93
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96
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100
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104
28
85
11
63
13
21
85
18
54
107
108
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111
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114
115
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119
25
81
61
12
16
22
86
19
61
122
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133
134
24
72
54
11
24
87
20
63
137
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149
22
70
33
32
31
29
28
25
89
21
65
152
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164
65
10
99
97
22
70
168
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178
63
61
54
33
32
31
29
28
25
24
183
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193
21
20
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11
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16
10
99
97
89
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81
72
16
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167
182
197
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232
Reg
Bin
Bin
75
90
105
120
135
150
165
179
180
194
195
209
210
224
225
239
240
Bin
Ref
Assay Specific
Magazine with 12 pre-spotted
BioFilmChip Microarrays
10
11
12
13
14
16
17
18
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21
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24
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10
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90
38
27
30
97
61
38
27
94
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103
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105
39
63
37
60
63
39
63
110
111
112
113
114
115
116
117
118
119
120
133
134
135
148
149
150
163
164
165
178
179
180
Reg
91
92
93
16
106
107
108
109
7
60
61
16
62
60
61
121
122
123
124
125
126
127
128
129
130
131
132
97
89
39
82
97
89
139
140
141
142
143
144
145
146
147
37
62
90
38
90
37
82
90
154
155
156
157
158
159
160
161
162
30
82
10
27
89
30
62
10
169
170
171
172
173
174
175
176
177
136
151
166
15
Reg
137
152
167
138
153
168
16
16
181
182
183
184
185
186
187
188
189
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191
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225
226
227
228
229
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231
232
233
234
235
236
237
238
239
240
Ref
Reg
Anti-Zipcode X
B
Zipcode X
Blood
Tissue
Urine
Nasopharyngeal swabs
Vaginal smears
Buccal swabs / Saliva
Contains Analyte
Specific Primer to be
extended
Assay identification
Reagent lot number
Expiration date
Number of tests remaining
Foil sealed reagent compartments
Automatically pierced during processing
Evaporation control
BioFilmChip Magazines
INFINITITM Analyzer
Intellipac Reagent Module
24 Well plate
INFINITI Analyzer
Sample Handling Unit
Pipettor Assembly
Display
Confocal
Microscope
BioFilmChip
Magazines
Intellipac
Hybridization
Chamber
R/W CD
Temperature Cycler
HPV
-
Cancer Dx
Colorectal
-
Genotyping*
QUAD*
HR QUAD*
HR HEX*
KRAS-BRAF*
KRAS*
5FU*
UGT1A1*
NAT-2*
STD
Melanoma/Thyroid
- BRAF*
- BRAF XP*
STD-6 QUAD*
Leuko QUAD*
Urogen QUAD*
CT-NG QUAD*
Vaginitis
- Bacterial Vaginosis*
- Candida Vaginitis*
Breast
-
CHEK-2*
BCP-AJ*
2D6T*
TAMX3*
Lung (NSCLC)
- EGFR*
10
Cardiovascular
Coumadin
- Warfarin (IVD)
- 2C9-VKORC1*
Infectious Diseases
-
Clopidogrel
CYP2C19 (IVD)
CYP2C19 QUAD
2C19 Plus*
Coagulation Disorders
F II (IVD)
F V Leiden (IVD)
MTHFR*
F II-V (IVD)
F II-V-MTHFR*
F II Plus*
F II Plus-V*
F II Plus-V-MTHFR*
F V Genotyping*
Risk Assessment
- Apo E*
12
Menu Expansion
15
RVP Plus*
MDR-TB*
NTM*
Flu A-sH1N1*
Genetic Disorders
-
CFTR 31*
CFTR 15*
Ashkenazi Jewish Panel*
FMF Panel*
Codeine
- CODX2*
Multidrug
-
2D6I*
3A4*
3A5*
MDR-1*
13
Array
Types
SINGLE
DUAL
QUAD
HEX
OCTO
Samples
/ array Assays
1
2
4
6
8
ALL
FMF
HPV, STD
HPV HR
MTB
Infectious
Diseases
Personalized
Medicine
Cancer
Genetic
Disorders
Regulatory Status
510K clearances from FDA
1Q2007:
INFINITI Analyzer
INFINITI Factor II / V Reagents
1Q2008:
4Q2010:
INFINITI CYP2C19
CE Marked Products
22 CE Marked Products
CE Marked Products
1. INFINITI Analyzer
2. INFINITI Factor II
3. INFINITI Factor V
4. INFINITI MTHFR
5. INFINITI Factor II-V
6. INFINITI Factor II-V-MTHFR
7. INFINITI CFTR 31
8. INFINITI HPV Genotyping
9. INFINITI HPV-HR QUAD
10.INFINITI HPV QUAD
11.INFINITI Warfarin Assay
12.INFINITI CYP450 2C9-VKORC1
13.INFINITI CYP450 2C19+
SAMPLE PREPARATION
Detection
primer
extension
Extended Primers
hybridized to zip
codes on
BioFilmChip
Wash
Scan Chip
Data Analysis
& Result Report
TEST PROCESSING
RESULTS
Amplification
Purified
DNA
Tabulated
Amplified
Sample
AutoGenomics
Hands on Time
< 5 min
< 5 min
Process Time
~ 20 min
~ 85 min
< 5 min
210 min
< 15 min
315 min
Oncology
Colorectal
- KRAS-BRAF
- KRAS
- 5-FU
- UGT1A1
- NAT-2
Melanoma/Thyroid
- BRAF
- BRAF XP
Breast
- CHEK-2
- BCP-AJ
Lung (NSCLC)
- EGFR
Pgx
Coumadin
- Warfarin
- 2C9-VKORC1
Clopidogrel
- CYP2C19
- Single format
- Quad format
- 2C19 Plus
Tamoxifen
- 2D6T
- TAMX3
Codeine
- CODX2
Pain Management
- 2D6I
- 3A4
- 3A5
Risk Assessment
- ApoE
- MDR1
Menu Exp
Infectious Diseases
- RVP Plus
- MDR-TB
- NTM
- Flu A-sH1N1
Genetic Disorders
- CFTR 31
- CFTR 15
- Ashkenazi Jewish Panel
- FMF Panel
Coagulation Disorders
- F II
- F V Leiden
- MTHFR
- F II-V (IVD)
- F II-V-MTHFR
- F II Plus
- F II Plus-V
- F II Plus-V-MTHFR
- F V Genotyping
23
HPV-HR QUAD
Simultaneous detection of 14
high-risk types individually
HPV-QUAD
HPV-HR HEX
Simultaneous detection of 5
individual high risk types,
8 high risk in pairs, and
2 low risk in pairs
Simultaneous detection of 14
high-risk types individually
Genotyping Matters
Genotyping offers superior Sensitivity and
Specificity over that of conventional screening.
Type 16 & 18 behave differently than other HR types
Discrimination between persistent and new
infection requires knowledge of genotype
Following persistent type specific infections is a
central part of management
META-ANALYSIS OF 14,500
CERVICAL CANCER CASES
HPV Genomics
Circular genome consisting of:
6 Early gene (E1, E2, E4, E5, E6, E7) regions
2 Late gene (L1, L2) regions
Disruption of any region in the above chain of events will halt the cycle!
Source: Stanely et al., Gynecologic Oncology, May 2010, 117(2):S5-S10
Assay Performance
Analytical Sensitivity:
5 10 copies
depending on microorganism
AutoGenomics
CT-NG QUAD
Chlamydia trachomatis
Neisseria gonorrhea
Trichomonas vaginalis
Mycoplasma genitalium
Mycoplasma hominis
Ureaplasma urealyticum
Leuko QUAD
Urogen QUAD
Sample:
Sample Preparation:
Results
16 samples in 4 hrs.
24 samples in 51/2 hrs.
INFINITI BV QUAD
Detects:
B. fragilis
M. mulieris
A. vaginae
G. vaginalis
M. curtisii
P. bivia
Sample:
Sample Preparation:
Results
16 samples in 4 hrs.
24 samples in 51/2 hrs.
INFINITI CV QUAD
Detects:
C. albicans
C. krusei
C. tropicalis
C. glabrata
C. parapsilosis
Sample:
Sample Preparation:
Results
16 samples in 4 hrs.
24 samples in 51/2 hrs.
KRAS-BRAF Mutations
Mutations in the KRAS & BRAF oncogenes are frequently found in human
cancer.
Approximately 45% of metastatic colorectal cancer patients (KRAS)
Approximately 12% of metastatic colorectal cancer patients (BRAF)
Colorectal (primarily)
Pancreatic
Lung
Gall Bladder
Bile Duct
Thyroid
INFINITI KRAS-BRAF
The INFINITI KRAS-BRAF Assay is designed to identify a total of 23 mutations in KRAS
Codons 12, 13, 61 and BRAF Codon 600.
Test Format:
Polymorphisms in these two genes may determine the grade of toxicity and effectiveness
of various anti-EGFR drugs.
Specimen Types
The following sample types are compatible with the
INFINITI KRAS-BRAF:
1.
2.
3.
4.
5.
INFINITI BRAF XP
The INFINITI BRAF XP Assay is designed to identify a total of 17 mutations in BRAF
Codons 600, 464, 466, 469, 597, 601.
Test Format:
Codon 600 (7 mutations):
G464E, G464V
G469A, G469E
L597R, L597V
K601E
5- Fluorouracil
More than 2 million patients with breast cancer, colon cancer, skin cancer or head
and neck cancer are treated with 5-Fluorouracil (5-FU) each year.
Almost standard of care for colorectal cancer patients
Even with the arrival of new biologic agents against colon cancer, 5-FU remains a
mainstay of treatment but carries a high risk of adverse effects.
Genetic variations in 3 different genes have been shown to impact the effectiveness
of 5-FU dosing.
INFINITI 5-FU
The INFINITI 5-FU Assay is designed to identify a total of 8 mutations in DPYD,
TYMS, and MTHFR genes in patients undergoing chemotherapy with 5-FU.
Test Format:
DPYD (5 Mutations):
85T>C,
IVS14+1 G>A
1590T>C
1679T>G
2846A>T
TYMS (1 Mutation):
MTHFR (2 Mutations):
677C>T, 1298A>C
Polymorphisms in these three genes may determine the grade of toxicity and
effectiveness of 5-FU.
UGT1A1
NAT-2 Panel
Variants detected (7):
CHEK-2 Panel
Variants detected:
EGFR
Lung cancer is leading cause of mortality in the world.
Non-Small Cell Lung Carcinomas (NSCLC) account for 85% of
lung cancer cases, and chemotherapy is only marginally
effective as a treatment.
Epidermal Growth Factor Receptors (EGFR) are present on
cells of epithelial origin and is often over-expressed in cases
of NSCLC.
INFINITI EGFR
The INFINITI EGFR assay detects mutations in exons 18, 19, 20 and 21 that confer
sensitivity to drugs such as Gefitinib and Erlotinib.
Exon 18: (10)
Different drug?
Normal dose OK
Drug A
Side effects
Metabolic
Character
Drug B
Ineffective
Drug C
Drug D
TARGETED
Significance of Pharmacogenomics
A patients inherited genetic makeup and their
response to pharmaceutical drugs are seen with
regards to their metabolism.
Ultra-rapid
Normal
Poor
Metabolizer
Metabolizer
Metabolizer
Under-dosed:
Expected
Lack of Efficacy
Response
Over-dosed:
Adverse Drug
Reactions
7. 2E1
8. 3A4
9. 3A5
10. 3A7
2nd highest selling drug in the world for the past 4 years
Sales of $6.35 Billion in 2010 (2nd only to Lipitor 12.9B)
Current Estimated Growth = 16%
~$4/pill, ~$120/month, ~$1500/year
INFINITI 2C19
The 2C19 test for Plavix should be considered for any patient taking or
considering Plavix (especially those with stents or considering stents).
INFINITI CYP2C19:
Antidepressants (Prozac)
2.
Antiepileptics (Valium)
3.
Gender
Age
VKORC1
VKORC1
(Up to 37%)
Body Weight
CYP 2C9
Others
Diet
Race
Race
Body Weight
Diet
Drugs
Others
Gender
Age
CYP 2C9
(Up to 22%)
VKORC1 Variants:
Sample:
Whole Blood
Buccal Cells
Sample Preparation:
2D6
Metabolizes more than 25% of all approved drugs
(mainly associated with Antidepressants & Pain
Management medications).
Ultrarapid
Metabolizer
Normal
Metabolizer
Underdosed Lack of
Efficacy
Expected
Response
Poor
Metabolizer
Overdosed
Serious ADRs=
seizure, stroke,
cardiac arrest, death
INFINITI 2D6 I
INFINITI CYP2D6i Assay
Reduced Function Alleles:
*9, *10, *17, *29, *41
Non-Functional Alleles:
*3, *4, *5, *6, *7, *8, *12, *14
Notable Mention:
*10, *12:
Affects metabolism of
neuroactive substances
*10, *14:
3A4/3A5
CYP450 3A4/3A5 is the most abundant CYP450 isoenzyme in
humans
Responsible for the metabolism of the widest range of
drugs/substances (55%) .
INFINITI 3A4/3A5
Involved in the metabolism and clearance of:
Antidepressants
Statins
HIV protease Inhibitors
Anti-thrombolytics
Calcium Channel Blockers
INFINITI 3A4 : *1B, *2, *3, *12, *17
INFINITI 3A5 : *1D, *2, *3A, *3B, *6, *7, *8, *9
Infectious Diseases
- RVP Plus
- MDR-TB
- NTM
- Flu A-sH1N1
Viral Incidence
Estimated Viral Incidence Distribution
Coronavirus
5%
Adenovirus
15%
Parainfluenza
15%
Metapneumovirus
5%
Other
2%
Influenza
20%
Rhinovirus
18%
RSV
20%
Detects:
Sample:
Purified RNA
Specimen Collection
TB and TB Facts
TB causes about 1.6 million deaths worldwide each year
In humans, TB can also be caused by:
-M. tuberculosis
-M. bovis
-M. africanum
-M. microti
-M. canettii
First-line TB drugs include:
Rifampin (RIF)
Isoniazid (INH)
Pyrazinamide (PZA)
Ethambutol
Streptomycin
Multidrug Resistant TB
Multidrug resistant TB: resistance to at least two first-line drugs
An estimated 50 million persons worldwide may be infected with
drug-resistant strains of TB, with 300,000 new cases each year*
Seventy-nine percent of multidrug resistant cases now show
resistance to three or more drugs
Extreme drug resistance (XDR-TB): resistance to three or more of
the six classes of second-line
drugs
INFINITI MDR-TB
Detects:
Tuberculous complex
Resistant strains:
Wild Types
Isoniazid Resistant
Pyrazinamide Resistant
Rifampin Resistant
Sample:
Sample Preparation:
INFINITI MDR-TB
Unparalleled specificity
NTM
Nontuberculous mycobacteria (NTM):
All mycobacteria other than:
Mycobacterium tuberculosis complex (MTB)
Mycobacterium leprae
INFINITI NTM
Detects:
M. avium complex
M. kanasii
M. chelonae
M. abscessus / M. mucogenicum
M. marinum/M. ulcerans
M. haemophilum
M. xenopi
M. gordonae
M. scrofulaceum
M. fortuitum
M. smegmatis.
Sample:
Sample Preparation:
Method of Identification:
Method of Hybridization:
INFINITI NTM
Load-and-go automation!
different species
- ALL SPECIES detected on one chip
Factors
The INFINITI System Assay for Factor II (Prothrombin) & Factor V Leiden is
indicated for use as an aid to diagnosis in the evaluation of patients with
suspected thrombophilia.
The Factor II (Prothrombin) variant gene is the second most common genetic
defect for inherited thrombosis.
INFINITI Factors
The increased risk of venous thrombosis in patients who are heterozygous for the FII
polymorphism is 3-fold.
The Factor V Leiden mutation is the most common variant associated with
inherited thrombosis.
MTHFR mutations have strongly been linked to cause hyperhomocysteinemia.
High levels of homocysteine (if high can be strongly correlated to risk of
cardiovascular disease)
INFINITI FII/FV/MTHFR
Factor II :
G20210A
Factor II Plus:
G20210A, G20209A
Factor V :
G1691A
MTHFR:
A1298C, C677T
FII-FV Panel :
G20210A, G1691A
FII-FV-MTHFR Panel:
CFTR
-
INFINITI CFTR
CFTR31: 25 Mutations + 6 Reflex
Genetic Variants on Panel (31):
G85E
R117H
I148T
621+1G>T
711+1G>T
1078delT
R334W
R347P
A455E
Delta I507
Delta F508
1717-1G>A
G542X
G551D
R553X
R560T
W1282X
1898+1G>A
2184delA
2789+5G>A
3120+1G>A
R1162X
3659delC
3849+10kbC>T
N1303K
IVS8 5T
IVS8 7T
IVS8 9T
I506V
I507V
F508C
Clinical Utility:
Disease
Mutations Screened
Ashkenazi
Carrier Rate
Bloom
2281del6/ins7
Canavan
Familial
Dysautonomia
R696P, IVS20(+6)T>C
Fanconi Anemia
322delG, IVS4(+4)A>T
1/89
Gaucher
1/15
Mucolipidosis IV
del6.4kb, IVS3(-2)A>G
Niemann-Pick
1/90
Tay-Sachs
1/30
1/100
1/50
1/32
1/127
ApoE
Apolipoprotein E (ApoE) is a gene that contains the instructions needed to make
a protein that helps carry cholesterol in the bloodstream. It can be used for
cardiovascular risk assessment to help make treatment decisions for individuals
with cardiovascular disease
ApoE has been linked to cardiovascular disease and progression of Alzheimer's
disease (AD). Identifying genetic mutations in ApoE has been shown to assist
patients and physicians in developing strategies to reduce the risk of AD as well
as other neurodegenerative disorders.
Every person has a set of three alleles (2, 3 and 4) of the ApoE gene, all of
which have different effects on the individual. The main mutations are 388T>C
and 526C>T.
INFINITI
ApoE
FMF
An inherited autosomal recessive disorder found predominantly
in populations originating near the Mediterranean Sea (though it
may affect any ethnic group).
Characterized by recurrent fever, painful inflammation of
abdomen, lungs, and joints, destructive oligoarthritis and renal
failure via amyloid deposit in kidneys .
1 in 200 people in afflicted populations have the disease.
INFINITI FMF
MEFV SNPs:
A774S
E148Q
F479L
I692del
K695R
M694V
M694I
M680I (G/A)
M680I (G/C)
P369S
R202Q
R761H
V726A
Sample:
Sample Preparation:
Womens
Health
Pharmocogenomics
FMF
Thallessemia
Genetics
Disorder
102
Cancer
Cardiovascular
Infectious
Disease
New Markets:
Statin Drugs
Alpha 1 Antitripsin
PGX
Pain Management
Cancer
Clinics
Pain Clinics
Hospitals
Orthopedics
Clinics
Mental Health
Pschiatry
Clinics
Ob/Gyn
Clinics
Cardiac
Assesment
Cardiology
Clinics
AutoGenomics
Thank you!