SARS-CoV-2 NeoPlex™ COVID-19

 The Novel Coronavirus 2019, was first reported on in Wuhan,

China in late December 2019.
 The outbreak was declared a global pandemic on March 11th, 2020.
 The virus has been named severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2).
 The disease caused by that virus is now officially has known as
coronavirus disease 2019 (COVID-19).

 The virus that causes COVID-19 infects people of

all ages.
 Overall case fatality rate is estimated to be
between 0.2~6.6%
 Coronavirus symptoms include fever, cough and
shortness of breath, also causes lung lesions and
pneumonia.
 Milder cases may resemble the flu or a bad cold,
making detection difficult.

Genematrix CONFIDENTIAL 2
 Introduction NeoPlex™ COVID-19

Organization Target Gene Primer / Probe Ref

Forward primer
WHO RdRp Reverse primer [1]
Probe
Forward primer
[1] Corman, Victor M., et al. "Detection of 2019 novel coronavirus (2019-nCoV)
by real-time RT-PCR." Eurosurveillance 25.3 (2020).
CDC N2 Reverse primer [2] [2] CDC. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.
https://www.cdc.gov/coronavirus/2019-ncov/downloads/rt-pcr-panel-primer
Probe probes.pdf

Target Dye

Forward Primer RdRp gene FAM

Probe

N gene HEX or JOE

Reverse Primer
IC Cy5

Genematrix CONFIDENTIAL 3
 Diagnosis Workflow NeoPlex™ COVID-19

Step 1. (1 hr) Step 2. (2 hr) Step 3. (5 min)

Nucleic Acid Extraction One-Step RT-PCR Data Analysis

PCR

RNA extraction from Amplified RdRp and GM Analysis Viewer

the patient specimens N genes emit two kinds of auto-analyze that the
fluorescence, letting users interpretation criteria
to identify SARS-CoV-2 for result analysis

Genematrix CONFIDENTIAL 4
 Main Features NeoPlex™ COVID-19

Fast Turnaround Time

Single-Tube Real-Time RT-PCR Reaction
- Within 3 hr analysis from nucleic acid extraction

Dual Targets suggested by US CDC and WHO

- RdRp and N genes Ease of Use

- Automated analysis with NeoPlex™ Viewer software

- One-Step RT-PCR without separate cDNA synthesis step
Specimens
- Whole process control with extraction control
- Sputum
- Bronchoalveolar lavage fluid (BAL)
- Nasopharyngeal or Oropharyngeal swab

Compatible Real-Time PCR instruments

- Applied Biosystems™ 7500 (Fast) Real-Time PCR

- CFX96™ Real-Time PCR
- Gentier96 Real-Time PCR

Genematrix CONFIDENTIAL 5
 Kit Components NeoPlex™ COVID-19

Storage
No. Contents Raw Materials Shelf life
Condition

① One-step Mastermix RT and PCR mastermix

PPM
② Primer/Probe mixture
(COVID-19 PPM)
-20 ℃ 5 months
PC
③ Cloned Plasmid DNA
(COVID-19 Positive Control)

④ DW RNase-free Water

① ② ③ ④
No more than 4 times of freeze/thaw is recommended

COVID-19 (CE-IVD)

 Simplified kit contents & improved Convenience

 High Stability of PCR Mastermix
 2~3 months effective period improvement compared to other companies)

Genematrix CONFIDENTIAL 6
 Result and Interpretation NeoPlex™ COVID-19

RdRp, N gene
* IC (Cy5)
Item (FAM, HEX or JOE) Interpretation
Result
Result

Ct ≤ 38 Positive (+)
Specimen
Ct >38 or
Negative (-)
N/A (Undetermined)

Positive Control Ct ≤ 30
Valid
* The Internal Control (IC) gene is to monitor the nucleic acid isolation procedure
Negative Control N/A (Undetermined)
and the possibility of PCR inhibition.

FAM HEX or JOE Cy5 Positive Negative

Case Interpretation
RdRp gene N gene IC * Control Control

1 + + + COVID-19

2 + + - COVID-19

3 - - + + - Negative

4 +/- +/- + Negative or Re-test

* IC is not necessary for the interpretation
**5 - - - Re-test of positive or negative results and high
load of pathogen’s nucleic acid results in
6 +/- +/- +/- +/- +
the low signal or negative signal of IC.
7 +/- +/- +/- - +/- Invalid
** Recommend re-extraction nucleic acid
8 +/- +/- +/- - - in specimens.

Genematrix CONFIDENTIAL 7
 Viewer Software NeoPlex™ COVID-19

GM Analysis Viewer Automatic result calling

- Data Management SW for Analysis, Display and Transfer
- User-Friendly interface specialized for Easy Multiplex testing
- High throughput and Convenient analysis

RdRp N

IC

Genematrix CONFIDENTIAL 8
 Analytical Sensitivity NeoPlex™ COVID-19

Instrument Target LoD RdRp N

RdRp 8.14 copies/ul

CFX96
N 8.34 copies/ul

RdRp 8.72 copies/ul

ABI7500 Target Target Conc. R2 Slope
N 8.79 copies/ul

RdRp 0.999 -3.444

RdRp 8.72 copies/ul 2x106, 2x105 2x104,
Gentier96 2x103, 2x102, 2x101 copies/ul
N 8.34 copies/ul N 0.999 -3.505

Genematrix CONFIDENTIAL 9
 Analytical Precision NeoPlex™ COVID-19

Repeatability and reproducibility was assessed by using high (10x LoD), mid (5x LoD), and low (2x LoD) concentration of
virus. Tests for Between-day, Between-lot, Between-tester, Between-instrument, and Between-site were confirmed.

Between Between Between Between Between

Target Day Lot Tester Instrument Site
Target
Conc.
SD CV(%) SD CV(%) SD CV(%) SD CV(%) SD CV(%)

10x LoD 0.18 0.55 0.45 1.33 0.47 1.41 0.48 1.42 0.46 1.36

RdRp
5x LoD 0.21 0.60 0.61 1.73 0.51 1.44 0.58 1.64 0.59 1.66

2x LoD 0.25 0.68 0.54 1.48 0.55 1.49 0.60 1.63 0.58 1.57

10x LoD 0.18 0.53 0.48 1.43 0.47 1.40 0.43 1.28 0.44 1.31

N
5x LoD 0.23 0.65 0.62 1.75 0.61 1.71 0.60 1.68 0.55 1.55

2x LoD 0.26 0.70 0.58 1.59 0.51 1.37 0.57 1.56 0.60 1.63

Genematrix CONFIDENTIAL 10
 Analytical Specificity NeoPlex™ COVID-19

14 substances, endogenous and exogenous source, were

assessed to determine their interfering effect and no No cross-reactivity was observed with 53 different pathogen strains
interference reactions was found with the concentration. similar with RI-pathogens and other pathogens(bacteria, virus, etc.).

No. Interfering substance Remark  Coronavirus-229E  Parainfluenza virus 1/2/3/4

1 Human Blood
Endogenous substances
2 Mucin
3 Dexamethasone
4 Zanamivir
5 Oseltamivir
6 Mupriocin
7 Tobramycin
 Coronavirus-OC43  Echovirus
 Coronavirus-NL63  Coxsackievirus
 Coronavirus-HKU1  Rhinovirus
 SARS-Coronavirus  Metapneumovirus
 MERS-Coronavirus  Streptococcus pneumoniae
 Influenza A  Haemophilus influenzae
 Influenza B  Mycoplasma pneumoniae
 Respiratory syncytial virus A/B  Chlamydophila pneumoniae
Exogenous substances  etc.

8 Lidocaine

9 Eucalyptol

10 Guaifenesin

11 L-Nicotine  This study was performed to evaluate the carry-over and potential
cross contamination effect.
Disinfecting/Cleaning
12 Ethanol  High concentrated positive sample and negative control sample
Substances
were cross tested using same PCR instrument, and 100% negative
13 Eswab™ (Copan 482C)
results (64/64)(95% Cl: 94.40%-100%) for each negative specimen
Rest™ UTM Transport Medium
14 were determined, respectively.
(NobleBio UTM-001B)

Genematrix CONFIDENTIAL 11
 Analytical Stability NeoPlex™ COVID-19

5 months

Reactivity: 2 times repeat / Reproducibility: 3 times repeat  We confirmed that product was stable for 5 months,

Titer and it was guaranteed that the stability of 28 days

Lot Target Condition Period
(copies/ul) after opening, and 4 times of frozen/thawed as the
results under all test conditions were stable.
4℃ Day 0 Day 15 Day 31
RdRp gene 104
A 001
N gene 103
A 002 15 ℃ Day 0 Day 7 Day 15
IC 102
A 003
NC 101
25 ℃ Day 0 Day 3 Day 7

28 days 4 times
Reactivity: 2 times repeat / Reproducibility: 3 times repeat
Reactivity: 2 times repeat / Reproducibility: 3 times repeat
Titer
Titer Target Count
Target Period (copies/ul)
(copies/ul)
RdRp
RdRp 104
104
gene
gene 103
103 N gene 0 times 3 times 5 times
N gene Day 0 Day 15 Day 30
102
102
IC
IC 101
101 NC
NC
 We confirmed that the product was stable for 30 days after opening.  We confirmed that the product was stable even when the product was
repeatedly frozen and thawed for 5 times.

Genematrix CONFIDENTIAL 12
 Clinical Accuracy NeoPlex™ COVID-19

 The clinical performance evaluation was performed in a clinical reference laboratory with the
specimens collected from various sources, such a hospitals or clinics under IRB review.
 The comparable CE-marked product already available on EU market was used as a comparator method.
 The specimens were confirmed Positive/Negative of SARS-CoV-2 by WHO recommended technique
as a reference method.
 Clinical sensitivity and clinical specificity of NeoPlex COVID-19 were shown to be 100% and 100%,
respectively and there were no false positive/negative cases found.

Target Clinical sensitivity Clinical specificity

100% (30/30) 100% (120/120)

RdRp gene
[95% CI 88.43-100] [95% CI 96.97-100]

100% (30/30) 100% (120/120)

N gene
[95% CI 88.43-100] [95% CI 96.97-100]

No. of Positive=30, No. of Negative=120

Genematrix CONFIDENTIAL 13
 Comparative Advantages NeoPlex™ COVID-19

NeoPlex™ PowerChek™
Advantages
COVID-19 2019-nCoV
Principle Real-Time PCR Real-Time PCR

- NeoPlex : RdRp & N genes: 2019-novel Coronavirus-

specific dual target genes for better specificity
Target genes RdRp, N RdRp, E
- PowerChek : RdRp & E genes: possible to interfere each other
E gene: broadly specific to common beta-Coronavirus

No cross reactivity tested with more than 50 of the respiratory

Specificity High NA pathogens (bacteria and virus) including the existing
Coronavirus (229E, OC43, NL63, HKU1)

LoD 10-5 10-3 At least 10 times more sensitive and 6-log dynamic

Available to check both of PCR process and nucleic acid

Whole process control Available Not available extraction processes using endogenous gene in specimens as
internal control

PCR tube
1 2 User-friendly and less hands-on time
reaction per test

PCR machine for

1 cycler 2 cyclers Less need for PCR machine
testing 96 samples

Number of tests
96 48 2-fold
per kit

TAT 3 hrs 6 hrs Fast Turnaround Time

Shelf life 5 months 6 weeks Excellent reagent stability

Genematrix CONFIDENTIAL 14
 Comparative Performance NeoPlex™ COVID-19

NeoPlex™ COVID-19 PowerChek™ 2019-nCoV

(RdRp, N gene) (RdRp, E gene)
RdRp RdRp

10-2 10-2
10-3 10-3
10-4 10-4
10-5 10-5(N/A)

N Vs E
10-2 10-2
10-3 10-3
 Test materials : 10-4 10-4
Standard 2019-nCoV gRNAs 10-5 10-5
supplied by Korean CDC
Ct ≤ 38, Positive
NeoPlex
COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 COVID-19
COVID-19
RNA(Original) RNA(10-1) RNA(10-2) RNA(10-3) RNA(10-4) RNA(10-5)
(GeneMatrix)

RdRp gene 22.32 25.84 29.14 32.09 35.04 37.14

N gene 20.04 23.17 26.78 30.34 33.25 36.50
Ct ≤ 35, Positive
PowerChek
COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 COVID-19
2019-nCoV
RNA(Original) RNA(10-1) RNA(10-2) RNA(10-3) RNA(10-4) RNA(10-5)
(Kogen)

RdRp gene 22.04 25.67 28.73 32.18 36.27 N/A

E gene 19.32 22.31 25.34 29.43 33.01 36.64 15
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