ORDERI N G I N FO RM ATI O N
QuantidexTM DNA Assay*
[P/N 0649539] 100 REACTIONS
*Research Use Only. Not for use in diagnostic procedures.
RE FE RE N C E S
1. Functional DNA quantification guides accurate next-generation sequencing mutation detection in
formalin-fixed, paraffin-embedded tumor biopsies. Sah et al. Genome Med 2013;5(8):77
Measure the DNA that Matters.
2500-0495 11/7/14
2150 W O O D WA R D S T. , S U I T E 10 0
AU S T I N , T X 7874 4
T: 1. 877.777.1874
P : 1. 512 . 6 81. 520 0
E : O R D E R S @A S U R AG E N .CO M
DISCOVER • DE VELOP • DIAGNOSE
Quantidex DNA A ssay
TM
Measures the DNA that matters: PCR-amplifiable DNA
# DETECTED COSMIC VARIANTS
A SSAY FE AT U RE S
GUIDES DNA INPUT TO IMPROVE THE ACCURACY OF NGS VARIANT CALLS
AND RESCUES FALSE POSITIVE AND NEGATIVE CALLS
16
12
10
TRUE POSITIVE
8
6.3 ng
6
12.5 ng
2
50
100
200
# OF AMPLIFIABLE DNA COPIES
Figure 2 : The specificity of NGS mutation detection can be dramatically improved by increasing the input of amplifiable DNA from a low-quality FFPE tumor biopsy
(QFI Score= 2.6%). Although the expected BRAF V600E mutation is detected at all inputs, the number of false positives is significantly increased at lower copy
number inputs. The Quantidex™ DNA Assay informs an input of 200 amplifiable copies, which is associated with detection of a single variant, the expected BRAF V600E mutation.
The mass inputs at the top of each bar were measured using spectrophotometry.
I D E N T I FI E S P C R I N H I B I TO R S PR E S E N T I N T H E SA M PL E
3 0F 3
INHIBITED
INHIBITION (Cq)
40
2 0F 3
INHIBITED
1 0F 3
INHIBITED
38
36
34
32
30
E X T E N S I V E LY VA L I DAT E D I N
PE E R - R E V I E W E D PU B L I C AT I O N S
QFI TM SCORE
10
1866 RESIDUAL CLINICAL FFPE SPECIMENS FROM 13 COHORTS
IM1
8
IM2
5
IM3
3
100
80
60
50
40
30
0
1
2
20
3
4
5
6
7
8
9
10
11
12
13
14
15
Figure 3 : Data from 15 melanoma FFPE DNA samples isolated with three different isolation methods (IM1, IM2, IM3).
A high Cq is an indicator of inhibition in a sample.
10
QFI TM SCORE
25.0 ng
25
A 2-in-1 assay: Distinguishes low-quality, unamplifiable DNA
from DNA with sample-derived PCR inhibition
Simple, high-throughput workflow using a convenient
multiplexed design
FALSE POSITIVE
1 TRUE POSITIVE
NO FALSE POSITIVES
4
0
Provides actionable guidance that rescues low-quality DNA
and helps assure the accuracy of NGS calls
MELANOMA FFPE
DNA 2.6% QFI
SCORE
3.1 ng
14
7
6
5
4
3
PR OV I D E S AC T I O N A B L E G U I DA N C E F O R D N A I N PU T S
I N TO D O W N S T R E A M N G S E N R I C H M E N T S T E P S
2
1
0.8
0.6
0.5
0.4
0.3
SAMPLE NAME
DNA INPUT (ng)
INHIBITION
AMPLIFIABLE COPY
NUMBER PER µl
QFI TM SCORE
MIN VOLUME TO
DETECT 5% VARIANT
(µl)
SAMPLE A
10
PASS
300
10.0
1.00
SAMPLE B
10
PASS
856
28.5
1.00
SAMPLE C
15
FAIL
FAIL
FAIL
FAIL
SAMPLE D
5
AT RISK
56
3.7
3.57
SAMPLE E
20
PASS
8
0.1
FAIL
0.2
0.1
0.07
0.06
0.05
0.04
0.03
0.02
N=92
82
QFI=26% 7%
24
9%
244
6%
96
4%
36
20%
660
4%
35
11%
27
17%
11
2%
462
21%
25
0.9%
72
9%
0.01
Figure 1 : The QuantidexTM DNA assay has been assessed with >2000 FFPE and FNA tumor biopsies across more than a dozen different cohorts.
Each sample is represented by its corresponding QFITM Score.
Figure 4 : Actionable results generated from the Quantidex DNA assay. The results identify PCR inhibition, reveal the DNA quality score (QFITM Score),
and prescribe volume inputs based on sample-specific DNA copy number for theoretical detection of a 5% variant.