Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better...

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Intelligent Multiplexing Solutions for Better Health WWW.PLEXBIO.COM Intelligent Multiplexing Solutions for Better Health

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Page 1: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

Intelligent Multiplexing Solutions for Better HealthIntelligent Multiplexing Solutions for Better Health

W W W . P L E X B I O . C O M

W W W . P L E X B I O . C O M

6F-1, No. 351 Yangguang StreetNeihu District, Taipei City 114Taiwan, R.O.C.

Tel: (02) 2627-5878Fax: (02) 2627-5979Email: [email protected]

PlexBio Asia Business Headquarters

ASIA

Genemed Biotechnologies, Inc.458 Carlton CourtSouth San Francisco, CA 94080, USA

Tel: (650) 952-0110 or (877) 436-3633Fax: (650) 952-1060Email: [email protected]

NORTH AMERICA DISTRIBUTOR

Intelligent Multiplexing Solutions for Better Health

GenemedB i o t e c h n o l o g i e s , I n c .

Quality is in Our GenesTM

Page 2: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

PlexBio’s IntelliPlex™ technology utilizes barcoded magnetic beads (BMB). These flat microparticles have photolithographic barcoded beads and are composed of paramagnetic silicon wafers encapsulated in highly stable biocompatible polymer modified for DNA or protein attachment.

The digital barcodes allow our optical imaging system, the PlexBio 100™, to identify each bead under bright field with no ambiguity. The binary encoding principle allows us to offer up to 2^12 (4,096) unique barcodes.

The barcoded beads are chemically treated so that they can bind assay-specific biomolecules through activation of surface carboxyl groups. Biological probes or antibodies can be conjugated to beads so that each barcode corresponds to a particular target. The different barcoded beads are then mixed together with samples and fluorophore conjugate for multiplex DNA/RNA- and protein-based assays. The combination of probe or antibody identification through bead barcodes and target detection through fluorescence intensity results in a powerful, flexible multiplex platform for IVD applications and other research interests.

Advantages of IntelliPlex™ BMB• High classification accuracy• No fluorescent interference

• Excellent stability• Flexible multiplexing capability• Easy to handle

IntelliPlex™ Barcoded Magnetic Beads

PlexBio Co., Ltd. is a privately held biotechnology company with Asia headquarters in Taipei, Taiwan and US headquarters in South San Francisco. It was established in 2010 to provide powerful, innovative bioassay solutions for the life science and diagnostic industries by leveraging cutting-edge multiplex technologies. With rising healthcare costs and an increasing range of available tests, it becomes more important than ever for clinical and research lab to consider the costs of labor, time, and maintenance when it comes to assay formats.

Multiplexity is our proposed solution. Instead of running multiple individual assays for a sample, our barcoded magnetic beads (BMB) allow the end-user to test a given sample for multiple targets at a time. Combined with our automated procedure and cutting-edge optical imaging system, we can produce highly sensitive and specific results with low sample volumes.

We envision advancing the worldwide IVD industry with IntelliPlex™, our intelligent multiplexing technology. We strive to reduce costs while promoting health and wellness, and are confident that our powerful, reliable system will make PlexBio your preferred partner for multiplex assays.

About PlexBio Co., Ltd.

WWW.PLEXBIO.COM

DetectionAntibody

CaptureAntibody

Target Probe

Biotin

SA-PE

BarcodedBead

Immunoassays Molecular Assays

Bead count

Bead Type

Fluorescence 2515

39

1672

58

5

44

Add beads to wells

Results Table

Perform assay and image wells

Read barcodes and fluorescent signal

Barcode 116

Barcode 60

Barcode 102

Barcode 102Barcode 60 Barcode 116

Page 3: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

PlexBio’s IntelliPlex™ technology utilizes barcoded magnetic beads (BMB). These flat microparticles have photolithographic barcoded beads and are composed of paramagnetic silicon wafers encapsulated in highly stable biocompatible polymer modified for DNA or protein attachment.

The digital barcodes allow our optical imaging system, the PlexBio 100™, to identify each bead under bright field with no ambiguity. The binary encoding principle allows us to offer up to 2^12 (4,096) unique barcodes.

The barcoded beads are chemically treated so that they can bind assay-specific biomolecules through activation of surface carboxyl groups. Biological probes or antibodies can be conjugated to beads so that each barcode corresponds to a particular target. The different barcoded beads are then mixed together with samples and fluorophore conjugate for multiplex DNA/RNA- and protein-based assays. The combination of probe or antibody identification through bead barcodes and target detection through fluorescence intensity results in a powerful, flexible multiplex platform for IVD applications and other research interests.

Advantages of IntelliPlex™ BMB• High classification accuracy• No fluorescent interference

• Excellent stability• Flexible multiplexing capability• Easy to handle

IntelliPlex™ Barcoded Magnetic Beads

PlexBio Co., Ltd. is a privately held biotechnology company with Asia headquarters in Taipei, Taiwan and US headquarters in South San Francisco. It was established in 2010 to provide powerful, innovative bioassay solutions for the life science and diagnostic industries by leveraging cutting-edge multiplex technologies. With rising healthcare costs and an increasing range of available tests, it becomes more important than ever for clinical and research lab to consider the costs of labor, time, and maintenance when it comes to assay formats.

Multiplexity is our proposed solution. Instead of running multiple individual assays for a sample, our barcoded magnetic beads (BMB) allow the end-user to test a given sample for multiple targets at a time. Combined with our automated procedure and cutting-edge optical imaging system, we can produce highly sensitive and specific results with low sample volumes.

We envision advancing the worldwide IVD industry with IntelliPlex™, our intelligent multiplexing technology. We strive to reduce costs while promoting health and wellness, and are confident that our powerful, reliable system will make PlexBio your preferred partner for multiplex assays.

About PlexBio Co., Ltd.

WWW.PLEXBIO.COM

DetectionAntibody

CaptureAntibody

Target Probe

Biotin

SA-PE

BarcodedBead

Immunoassays Molecular Assays

Bead count

Bead Type

Fluorescence 2515

39

1672

58

5

44

Add beads to wells

Results Table

Perform assay and image wells

Read barcodes and fluorescent signal

Barcode 116

Barcode 60

Barcode 102

Barcode 102Barcode 60 Barcode 116

Page 4: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

The PlexBio 100™ (Cat. No. 80001) is a robust optical imaging system that is both highly effective and easy to use. The compact machine is simple to maintain – no wash or waste fluid management required – and it accurately decodes beads through high-contrast imaging. The system is compatible with any protein- or DNA-based assays using PlexBio’s IntelliPlex™ barcoded magnetic beads.

LEDThe PlexBio 100™ uses LED instead of complex lasers for both bright field illumination of barcodes and the excitation of the fluorescence reporter, which makes the PlexBio 100™ more affordable and compact. Calibration is a quick, simple process with the PlexBio 100™ Calibration Kit and takes less than 5 minutes.

CCD ImagerThe CCD camera works in conjunction with the moving stage to read each well in a 96-well plate. The imager will autofocus for each well to ensure optimal readings of the beads, then capture images in both bright field and fluorescence. Barcodes and fluorescence measurements are combined for each bead, resulting in reaction intensity data for multiple analytes per sample.

AccuracyDigital barcode classification means no fluorescence interference or gating issues; beads read on well bottom completely eliminates cross-over

EfficiencyRun multiple tests with one sample by multiplexing your assays in a compact machine

ConvenienceIntuitive, user-friendly interface with a short installation time, 15-minute startup, 5-minute calibration, and instant shutdown

Low-maintenanceNo fluids or probes mean no leaks, no waste bottles, and no fluids to refill

ReliabilityFew moving parts and no fluidics mean less downtime, troubleshooting, and servicing

Small footprintNot only is the PlexBio 100™ compact, but few additional laboratory equipment is needed to perform IntelliPlex™ assays

PlexBio offers barcoded beads with functional carboxyl groups on the bead surface for the covalent binding of probes or proteins of interest. Researchers can purchase carboxyl beads (Cat. No. 80100 and 80101) and coupling kits (Cat. No. 80200 and 80201) to multiplex their existing assays by attaching custom capture agents to BMB. The BMB can then be mixed for reacting with samples, allowing researchers to create multiplex assays that test for multiple targets in a single reaction.

Ease-of-useNon-light-sensitive beads mean that there’s no extra consumables and labor needed to keep assays in the dark

FlexibilityUse PlexBio’s commercial assays or develop your own, with up to 4096 unique barcodes to mix and match

TraceabilityOriginal data can be traced back to individual beads post assay

Internal assay performance monitoringBuilt-in monitors ensure that all steps of the assay were performed successfully as well as provide specific information for troubleshooting, if necessary

Automatic assay recognition The PlexBio 100™ will identify assay- and lot-specific information as well as external negative and positive controls without user input, which eliminates data entry as protocol and panel information are automatically loaded

Assay Development with IntelliPlex™

PlexBio 100TM

Digital Multiplex Analyzer

Benefits of PlexBio 100™ Digital Multiplex Analyzer Advantages of IntelliPlex™ Assays

Bright Field Image Fluorescent Image

OC

OC

OC

Biotin

Biotin

BiotinBiotin

Biotin

BMB N

BMB N

BMB N

BMB N

BMB N

BMB N

Hybridization

Target N

Target N

Probe N

Probe NProbe N

Sample Target N

Conjugated Antibody-Biotin

Target N

Probe N

SA-PE SA-PE

SA-PE

SA-PE

Sample (Biotinylated Oligonucleotide)

Molecular Assay Immunossay

Page 5: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

The PlexBio 100™ (Cat. No. 80001) is a robust optical imaging system that is both highly effective and easy to use. The compact machine is simple to maintain – no wash or waste fluid management required – and it accurately decodes beads through high-contrast imaging. The system is compatible with any protein- or DNA-based assays using PlexBio’s IntelliPlex™ barcoded magnetic beads.

LEDThe PlexBio 100™ uses LED instead of complex lasers for both bright field illumination of barcodes and the excitation of the fluorescence reporter, which makes the PlexBio 100™ more affordable and compact. Calibration is a quick, simple process with the PlexBio 100™ Calibration Kit and takes less than 5 minutes.

CCD ImagerThe CCD camera works in conjunction with the moving stage to read each well in a 96-well plate. The imager will autofocus for each well to ensure optimal readings of the beads, then capture images in both bright field and fluorescence. Barcodes and fluorescence measurements are combined for each bead, resulting in reaction intensity data for multiple analytes per sample.

AccuracyDigital barcode classification means no fluorescence interference or gating issues; beads read on well bottom completely eliminates cross-over

EfficiencyRun multiple tests with one sample by multiplexing your assays in a compact machine

ConvenienceIntuitive, user-friendly interface with a short installation time, 15-minute startup, 5-minute calibration, and instant shutdown

Low-maintenanceNo fluids or probes mean no leaks, no waste bottles, and no fluids to refill

ReliabilityFew moving parts and no fluidics mean less downtime, troubleshooting, and servicing

Small footprintNot only is the PlexBio 100™ compact, but few additional laboratory equipment is needed to perform IntelliPlex™ assays

PlexBio offers barcoded beads with functional carboxyl groups on the bead surface for the covalent binding of probes or proteins of interest. Researchers can purchase carboxyl beads (Cat. No. 80100 and 80101) and coupling kits (Cat. No. 80200 and 80201) to multiplex their existing assays by attaching custom capture agents to BMB. The BMB can then be mixed for reacting with samples, allowing researchers to create multiplex assays that test for multiple targets in a single reaction.

Ease-of-useNon-light-sensitive beads mean that there’s no extra consumables and labor needed to keep assays in the dark

FlexibilityUse PlexBio’s commercial assays or develop your own, with up to 4096 unique barcodes to mix and match

TraceabilityOriginal data can be traced back to individual beads post assay

Internal assay performance monitoringBuilt-in monitors ensure that all steps of the assay were performed successfully as well as provide specific information for troubleshooting, if necessary

Automatic assay recognition The PlexBio 100™ will identify assay- and lot-specific information as well as external negative and positive controls without user input, which eliminates data entry as protocol and panel information are automatically loaded

Assay Development with IntelliPlex™

PlexBio 100TM

Digital Multiplex Analyzer

Benefits of PlexBio 100™ Digital Multiplex Analyzer Advantages of IntelliPlex™ Assays

Bright Field Image Fluorescent Image

OC

OC

OC

Biotin

Biotin

BiotinBiotin

Biotin

BMB N

BMB N

BMB N

BMB N

BMB N

BMB N

Hybridization

Target N

Target N

Probe N

Probe NProbe N

Sample Target N

Conjugated Antibody-Biotin

Target N

Probe N

SA-PE SA-PE

SA-PE

SA-PE

Sample (Biotinylated Oligonucleotide)

Molecular Assay Immunossay

Page 6: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

IntelliPlex™ BMB Wash Station

PlexBio’s BMB Assay Processing Set (Cat. No. 80010) is designed for manual processing of IntelliPlex™ assays. The set includes all equipment necessary to perform the necessary wash, incubation, and demagnetization steps to prepare BMB for decoding.

The BMB Assay Processing Set includes the following:

BMB Assay Processing Set

DeXipher™ Software

Key Features Basic RU MD

Account #Account managementQuick readExport raw dataIdentify kit ID and lot IDCalibration: stage and fluorescenceDemo kitData and Report:check previou data/summary dataDefine Standard, Control ,and Sample wellsData analysis:Standard curve calculation and chartsKit Reports: ex HPV, KRAS, BRAF, cytokines,HCV and ToRch etc.Electronic signature: follow 21 CFR part 11Audit Trail: follow 21 CFR part 11

Depends

Depends

1

The PlexBio 100™ comes pre-installed with DeXipher™ basic, which includes instrument control and calibration, barcoded magnetic bead decoding and fluorescence detection, as well as raw data output.

• Easy to learn• Intuitive graphical user interface• View data in real time• Save well images for review• Export data as .pdf and .xls files

For more advanced functions such as IntelliPlex™ assay information, protocol and report settings, statistical analysis (such as curve-fitting, bar charts, recovery range, etc.), and multiple user accounts, upgrade to DeXipher™ RU or DeXipher™ MD.

Automate the BMB wash process with the IntelliPlex™ BMB Wash Station (Cat. No. 80017). The BMB Wash Station combines aspiration, reagent dispensing, shaking, and a magnetic plate for reducing BMB loss. The BMB Wash Station is pre-programmed with protocols for BMB processing. Using the 7-inch touch screen panel, users can run protocols as well as create custom protocols for assays using 96-well microtiter plates, including ELISA.

Vacuum Pump Set: Vacuum Pump, Waste Bottle, Filter, TubingShaker/Incubator

Manifold Set: Manifold, Adaptor, Manifold Stand, Manifold Guiding Plate, Magnetic PlateDe-Magnetizer

Page 7: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

IntelliPlex™ BMB Wash Station

PlexBio’s BMB Assay Processing Set (Cat. No. 80010) is designed for manual processing of IntelliPlex™ assays. The set includes all equipment necessary to perform the necessary wash, incubation, and demagnetization steps to prepare BMB for decoding.

The BMB Assay Processing Set includes the following:

BMB Assay Processing Set

DeXipher™ Software

Key Features Basic RU MD

Account #Account managementQuick readExport raw dataIdentify kit ID and lot IDCalibration: stage and fluorescenceDemo kitData and Report:check previou data/summary dataDefine Standard, Control ,and Sample wellsData analysis:Standard curve calculation and chartsKit Reports: ex HPV, KRAS, BRAF, cytokines,HCV and ToRch etc.Electronic signature: follow 21 CFR part 11Audit Trail: follow 21 CFR part 11

Depends

Depends

1

The PlexBio 100™ comes pre-installed with DeXipher™ basic, which includes instrument control and calibration, barcoded magnetic bead decoding and fluorescence detection, as well as raw data output.

• Easy to learn• Intuitive graphical user interface• View data in real time• Save well images for review• Export data as .pdf and .xls files

For more advanced functions such as IntelliPlex™ assay information, protocol and report settings, statistical analysis (such as curve-fitting, bar charts, recovery range, etc.), and multiple user accounts, upgrade to DeXipher™ RU or DeXipher™ MD.

Automate the BMB wash process with the IntelliPlex™ BMB Wash Station (Cat. No. 80017). The BMB Wash Station combines aspiration, reagent dispensing, shaking, and a magnetic plate for reducing BMB loss. The BMB Wash Station is pre-programmed with protocols for BMB processing. Using the 7-inch touch screen panel, users can run protocols as well as create custom protocols for assays using 96-well microtiter plates, including ELISA.

Vacuum Pump Set: Vacuum Pump, Waste Bottle, Filter, TubingShaker/Incubator

Manifold Set: Manifold, Adaptor, Manifold Stand, Manifold Guiding Plate, Magnetic PlateDe-Magnetizer

Page 8: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

The PlexBio IntelliPlex™ system exhibits high sensitivity and can detect small amounts of targetmolecules. When performing a typical HPV DNA screening assay with the PlexBio multiplex platform, it is possible to detect less than 5 copy numbers of type 18 HPV DNA. Using immunoassays, we can detect PBK at levels below 5 pg/mL, with a detection range of 6 logs.

IntelliPlex™ Assay Performance IntelliPlex™ EGFR, BRAF, and KRAS Mutation Kits

150 cervical specimens were analyzed with both the IntelliPlex™ HPV Genotyping Kit and a commercially available HPV assay. The two kits produced the same results for 18 positive samples and 118 negative samples. For the samples for which the two kits produced differing results, type-specific PCR and sequencing were performed with the sample. In all 14 cases, the sequencing results matched that of the IntelliPlex™ HPV Genotyping Kit rather than that of the commercially available assay.

The IntelliPlex™ EGFR, BRAF, and KRAS Mutation Kits were tested with genomic and plasmid DNA to evaluate the sensitivity and specificity of the three assays. The data shows that all three assays exhibit high sensitivity and specificity for the detection and differentiation of all mutations included in the kits. The S/CO ratios shown in the table were derived by dividing the sample fluorescent signal by pre-determined cutoff values for each BMB, which are coated with different probes that are specific for different target mutation amplicons.

IntelliPlex™ HPV Genotyping Kit

• DNA Hybridization Sensitivity with HPV Type 18

1000

Copy Number of HPV Type 18 Amplicon

Fluo

resc

ence

200400600800

10001200140016001800

1 10 1000

DNA Copy Number

1000500100503010510

Fluorescent Signal

1613148496260939115359328

PBK Concentration (ng/mL)

Fluo

resc

ence

0.001 0.01 0.1 1 10 100 1000 10000 100000

12000

14000

10000

8000

6000

4000

2000

0

• Immunoassay Sensitivity with PBK

Antigen (ng/mL)

500005005

0.50.005

0

Fluorescent Signal

1386111516611113321033

True HR HPV Positive

True HR HPV Negative

Sensitivity (%) Specificity (%)

IntelliPlex™ HPV Genotyping Kit

PositiveNegative

Commercially Available Assay

PositiveNegative

230

185

0127

9118

100.0 %100.0 %

78.3 %92.6 %

KRAS

BRAF Assay

0000000

2.0

BMBProbe

Genomic DNA Mutant plasmid DNA

V600E/DV600DV600GV600KV600RV600MRef Gene CtrlInt Ctrl

000000

8.92.0

12.00.70.10.3

02

9.62.7

11.20.60.30.2

01.99.63.0

6.80.40.2

00

1.38.72.0

10.79.70.40.2

03.5

92.6

00

2.8000

9.21.8

0.30.20.43.7

01.49.63.0

00

0.406

0.19.22.5

00.30.6

00

1.49.32.7

WT(50ng)

WiDr(V600E1)

1%

V600E11%

V600E21%

V600D1%

V600G1%

V600K1%

V600R1%

V600M1%

NegCtrl

G12AG12DG12VG12CG12SG13DG13CG12RG13AG13VG13RG13SRef Gene CtrlInt Ctrl

0.50.40.10.10.6

00

0.60.40.10.10.2

11.30.8

5.01.00.70.80.91.4

00.80.90.3

00.22.02.5

01.60.10.61.40.4

01.00.30.30.50.6

11.12.2

0.70.72.8

00.80.9

00.80.30.2

00.5

11.02.5

0.50.60.36.00.80.0

00.81.10.10.60.3

11.02.0

0.20.7

00

2.00.9

00.60.7

00.30.4

11.12.6

00.51.1

00.81.4

01.10.1

00.40.2

12.02.6

0.20.3

00.60.60.48.60.40.4

00.5

010.0

0.2

0.81.20.10.90.90.7

02.71.00.20.80.32.50.0

0.70.6

00.00.70.0

00.33.50.3

01.0

10.90.0

0.61.3

00.80.60.1

00.20.72.40.60.16.20.3

01.3

00.50.70.8

00.60.20.07.50.44.43.6

00.4

00.10.80.6

01.00.2

00

4.210.82.1

0000000000000

3.1

CCL155(G12A)

1%

CRL2558(G12D)

1%

CCL228(G12V)

1%

CRL5807(G12C)

1%

CCL255(G12S)

1%

HCT116(G13D)

1%

CRL5891(G13C)

1%

G12R1%

G13A1%

G13V1%

G13R1%

G13S5%

NegCtrl

WT (50ng)

Genomic DNA Mutant plasmid DNA

BMBProbe

EGFRGenomic DNA

NegCtrl

WT (50ng)

BMBProbe

Cosmic ID 62526253623962236225260381267812383621862551237012384

0.60.40.20.20.10.70.4

00

0.20

0.3

2.70.20.30.30.10.60.2

00

0.20

0.3

00.40.21.80.20.80.4

00

0.20

0.1

0.40.30.30.40.20.90.5

00.10.70.10.2

000000000000

SW48(G719S/6252) 1%

CRL5883(Exon19 Del/

6223) 1%

CRL5908(T790M/6240 &

L858R/6224) 1%

Genomic DNA

BMBProbe

NegCtrl

WT (50ng)

SW48(G719S/6252) 1%

CRL5883(Exon19 Del/

6223) 1%

CRL5908(T790M/6240 &

L858R/6224) 1%

123821238762106254/12369624062411237662246213Ref Gene CtrlInt Ctrl

0.10.3

00.40.40.2

00.1

05.54.5

00.2

00.40.30.30.10.30.15.74.2

00.2

00.30.30.50.40.5

05.54.4

00.4

00.21.60.50.41.6

05.14.6

0000000000

7.7

Page 9: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

The PlexBio IntelliPlex™ system exhibits high sensitivity and can detect small amounts of targetmolecules. When performing a typical HPV DNA screening assay with the PlexBio multiplex platform, it is possible to detect less than 5 copy numbers of type 18 HPV DNA. Using immunoassays, we can detect PBK at levels below 5 pg/mL, with a detection range of 6 logs.

IntelliPlex™ Assay Performance IntelliPlex™ EGFR, BRAF, and KRAS Mutation Kits

150 cervical specimens were analyzed with both the IntelliPlex™ HPV Genotyping Kit and a commercially available HPV assay. The two kits produced the same results for 18 positive samples and 118 negative samples. For the samples for which the two kits produced differing results, type-specific PCR and sequencing were performed with the sample. In all 14 cases, the sequencing results matched that of the IntelliPlex™ HPV Genotyping Kit rather than that of the commercially available assay.

The IntelliPlex™ EGFR, BRAF, and KRAS Mutation Kits were tested with genomic and plasmid DNA to evaluate the sensitivity and specificity of the three assays. The data shows that all three assays exhibit high sensitivity and specificity for the detection and differentiation of all mutations included in the kits. The S/CO ratios shown in the table were derived by dividing the sample fluorescent signal by pre-determined cutoff values for each BMB, which are coated with different probes that are specific for different target mutation amplicons.

IntelliPlex™ HPV Genotyping Kit

• DNA Hybridization Sensitivity with HPV Type 18

1000

Copy Number of HPV Type 18 Amplicon

Fluo

resc

ence

200400600800

10001200140016001800

1 10 1000

DNA Copy Number

1000500100503010510

Fluorescent Signal

1613148496260939115359328

PBK Concentration (ng/mL)

Fluo

resc

ence

0.001 0.01 0.1 1 10 100 1000 10000 100000

12000

14000

10000

8000

6000

4000

2000

0

• Immunoassay Sensitivity with PBK

Antigen (ng/mL)

500005005

0.50.005

0

Fluorescent Signal

1386111516611113321033

True HR HPV Positive

True HR HPV Negative

Sensitivity (%) Specificity (%)

IntelliPlex™ HPV Genotyping Kit

PositiveNegative

Commercially Available Assay

PositiveNegative

230

185

0127

9118

100.0 %100.0 %

78.3 %92.6 %

KRAS

BRAF Assay

0000000

2.0

BMBProbe

Genomic DNA Mutant plasmid DNA

V600E/DV600DV600GV600KV600RV600MRef Gene CtrlInt Ctrl

000000

8.92.0

12.00.70.10.3

02

9.62.7

11.20.60.30.2

01.99.63.0

6.80.40.2

00

1.38.72.0

10.79.70.40.2

03.5

92.6

00

2.8000

9.21.8

0.30.20.43.7

01.49.63.0

00

0.406

0.19.22.5

00.30.6

00

1.49.32.7

WT(50ng)

WiDr(V600E1)

1%

V600E11%

V600E21%

V600D1%

V600G1%

V600K1%

V600R1%

V600M1%

NegCtrl

G12AG12DG12VG12CG12SG13DG13CG12RG13AG13VG13RG13SRef Gene CtrlInt Ctrl

0.50.40.10.10.6

00

0.60.40.10.10.2

11.30.8

5.01.00.70.80.91.4

00.80.90.3

00.22.02.5

01.60.10.61.40.4

01.00.30.30.50.6

11.12.2

0.70.72.8

00.80.9

00.80.30.2

00.5

11.02.5

0.50.60.36.00.80.0

00.81.10.10.60.3

11.02.0

0.20.7

00

2.00.9

00.60.7

00.30.4

11.12.6

00.51.1

00.81.4

01.10.1

00.40.2

12.02.6

0.20.3

00.60.60.48.60.40.4

00.5

010.00.2

0.81.20.10.90.90.7

02.71.00.20.80.32.50.0

0.70.6

00.00.70.0

00.33.50.3

01.0

10.90.0

0.61.3

00.80.60.1

00.20.72.40.60.16.20.3

01.3

00.50.70.8

00.60.20.07.50.44.43.6

00.4

00.10.80.6

01.00.2

00

4.210.82.1

0000000000000

3.1

CCL155(G12A)

1%

CRL2558(G12D)

1%

CCL228(G12V)

1%

CRL5807(G12C)

1%

CCL255(G12S)

1%

HCT116(G13D)

1%

CRL5891(G13C)

1%

G12R1%

G13A1%

G13V1%

G13R1%

G13S5%

NegCtrl

WT (50ng)

Genomic DNA Mutant plasmid DNA

BMBProbe

EGFRGenomic DNA

NegCtrl

WT (50ng)

BMBProbe

Cosmic ID 62526253623962236225260381267812383621862551237012384

0.60.40.20.20.10.70.4

00

0.20

0.3

2.70.20.30.30.10.60.2

00

0.20

0.3

00.40.21.80.20.80.4

00

0.20

0.1

0.40.30.30.40.20.90.5

00.10.70.10.2

000000000000

SW48(G719S/6252) 1%

CRL5883(Exon19 Del/

6223) 1%

CRL5908(T790M/6240 &

L858R/6224) 1%

Genomic DNA

BMBProbe

NegCtrl

WT (50ng)

SW48(G719S/6252) 1%

CRL5883(Exon19 Del/

6223) 1%

CRL5908(T790M/6240 &

L858R/6224) 1%

123821238762106254/12369624062411237662246213Ref Gene CtrlInt Ctrl

0.10.3

00.40.40.2

00.1

05.54.5

00.2

00.40.30.30.10.30.15.74.2

00.2

00.30.30.50.40.5

05.54.4

00.4

00.21.60.50.41.6

05.14.6

0000000000

7.7

Page 10: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

IntelliPlex™ Products

Category Cat. No. Product Name

80001-1

80001-2

80017-1

80017-2

80050

80051

80010-1

80010-2

80015

80016

80100-XXX

80101-XXX

80200

80201

80202

80203

80205

81000-96

81001-96

81005-96

81002-96

81003

81004

82000-96

82003-24

82003-96

82004-24

82004-96

82005-24

82005-96

82006-24

82006-96

Instrument

Software

Accessories

Carboxyl BMBs

Reagents

Immunoassay Kits

Molecular Assay Kits

PlexBio is actively seeking distributors worldwide. If you are interested in collaborating with us, please email us at [email protected] or visit www.plexbio.com for more information

PlexBio 100™ (with Computer and DeXipher™ Basic), 110V

PlexBio 100™ (with Computer and DeXipher™ Basic), 220V

IntelliPlex™ BMB Wash Station, 110V

IntelliPlex™ BMB Wash Station, 220V

DeXipher™ RU

DeXipher™ MD

BMB Assay Processing Set, 110V(Includes: Shaker/Incubator, Pump Set, Manifold Set, De-Magnetizer)

BMB Assay Processing Set, 220V(Includes: Shaker/Incubator, Pump Set, Manifold Set, De-Magnetizer)

Magnetic Stand (for Vials)

PlexBio 100™ Calibration Kit

128-Plex BMB for Protein (0-127)

128-Plex BMB for DNA (128-255)

BMB-Protein Coupling Kit (for 500k beads)

BMB-Nucleic Acid Coupling Kit (for 500k beads)

Biotin-PEG4-NHS

Streptavidin-Phycoerythrin

BMB Wash Buffer (10X)

IntelliPlex™ TORCH Plus IgG Kit (96)

IntelliPlex™ TORCH Plus IgM Kit (96)

IntelliPlex™ TORCH Plus IgG Avidity Kit (96)

IntelliPlex™ Down Syndrome Kit (96)

IntelliPlex™ Cytokine Panel 1 (15 plex)

IntelliPlex™ Cytokine Panel 2 (15 plex)

IntelliPlex™ HPV Genotyping Kit (96)

IntelliPlex™ KRAS G12/13 Mutation Kit (24)

IntelliPlex™ KRAS G12/13 Mutation Kit (96)

IntelliPlex™ BRAF V600 Mutation Kit (24)

IntelliPlex™ BRAF V600 Mutation Kit (96)

IntelliPlex™ HCV 1-6 Genotyping Kit (24)

IntelliPlex™ HCV 1-6 Genotyping Kit (96)

IntelliPlex™ EGFR Mutation Kit (24)

IntelliPlex™ EGFR Mutation Kit (96)

IntelliPlex™ Assay Kits

PlexBio develops nucleic acid- and protein-based IntelliPlex™ assay kits designed to save time, labor, and patient sample, resulting in fast, reliable results at very low cost. Each of these kits is optimized to test for multiple targets in a single well, up to 96 tests at a time.

IntelliPlex™ HPV Genotyping Kit (Cat. No. 82000)

Infection of human papillomavirus (HPV) genotypes that are high-risk for developing into cervical and other cancers tends to be symptomless until the cancers are advanced, making early detection and treatment of HPV infections crucial. DNA screening for 10 HPV types, including 20 high-risk and 10 low-risk types.

IntelliPlex™ TORCH Plus IgG, IgM, and IgG Avidity Kit (Cat. No. 81000, 81001, 81005)

TORCH is an acronym for a set of infections that can be passed from mother to fetus, leading to severe birth defects or fetal death. Detection of TORCH infections early in pregnancy allows for more effective treatment, or even prevention of perinatal infection. Detection of serum IgG, IgM, or IgG Avidity against Toxoplasma gondii, Rubella, CMV, HSV-1 and -2, Chlamydia trachomatis, and Parvovirus B19.

IntelliPlex™ KRAS G12/13 Mutations Kit (Cat. No. 81002)

KRAS-activating mutations are associated with mCRC, NSCLC and other tumors. The mutational status can serve as critical supporting information on treatment options. Detection of 12 KRAS mutations on codon 12 and codon 13, including G12D, G12C, G12S, G12R, G12A, G12V, G13D, G13C, G13S, G13R, G13A, and G13V.

IntelliPlex™ KRAS G12/13 Mutation Kit (Cat. No. 82003)

KRAS-activating mutations are associated with CRC/mCRC, NSCLC, and other cancer patient tumors. The mutational status can serve as critical supporting information on treatment options. Detection and differentiation of 12 KRAS mutations on codons 12 and 13, including G12D, G12C, G12S, G12R, G12A, G12V, G13D, G13C, G13S, G13R,G13A, and G13V

IntelliPlex™ BRAF V600 Mutation Kit (Cat. No. 82004)

BRAF-activating mutations are mainly associated with melanoma, CRC/mCRC, and other cancer patient tumors. Like KRAS, the BRAF mutational

status can serve as critical supporting information on treatment options. Detection and differentiation of six BRAF mutations on codon 600, including V600E, V600K, V600D, V600G, V600R, and V600M

IntelliPlex™ EGFR Mutation Kit (Cat. No. 82006)

Epidermal growth factor receptor (EGFR) mutations can be found in some NSCLC patient tumors. The mutational status can serve as critical supporting information on treatment options since some mutations are associated with sensitivity and others resistance to EGFR tyrosine kinase inhibitors (TKIs). Detection and differentiation of 22 EGFR mutations in exons 18, 19, 20, and 21, including the activating mutations (such as the G719S/C/A mutations in exon 18, the deletion mutations, e.g., Cosmic IDs 6223 and 6225 mutations, in exon 19, and the L858R mutation in exon 21) and the major TKI-resistance mutation, T790M, in exon 20.

IntelliPlex™ Cytokine Panels (Cat. No. 81003 and 81004)

Cytokines are a family of small proteins that play critical roles in intercellular communication and can be important for biomedical, preclinical, and clinical studies. Detection of cytokines IL-1a, IL-1b, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL23 p40, IL-12 p70, IL-13, IL-15, IL-17a, IL-18, IFNa2, IFNg, IP-10, MCP-1, MIP-1a, RANTES, TNFa, VEGF-A, Gro-a/KC, Leptin, CSF, GMCSF, Eotaxin, and MIP-1b.

IntelliPlex™ HCV Genotyping Kit (Cat. No. 82005)

Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus (HCV). Chronic infections increase the risk of developing chronic liver disease, cirrhosis and liver cancer. HCV is divided into six genotypes and each genotype requires custom tailored treatment. Screening the genotype before treatment is therefore necessary to determine the most appropriate approach for the patient. Detection of six major HCV genotypes (1, 2, 3, 4, 5, 6).

Page 11: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

IntelliPlex™ Products

Category Cat. No. Product Name

80001-1

80001-2

80017-1

80017-2

80050

80051

80010-1

80010-2

80015

80016

80100-XXX

80101-XXX

80200

80201

80202

80203

80205

81000-96

81001-96

81005-96

81002-96

81003

81004

82000-96

82003-24

82003-96

82004-24

82004-96

82005-24

82005-96

82006-24

82006-96

Instrument

Software

Accessories

Carboxyl BMBs

Reagents

Immunoassay Kits

Molecular Assay Kits

PlexBio is actively seeking distributors worldwide. If you are interested in collaborating with us, please email us at [email protected] or visit www.plexbio.com for more information

PlexBio 100™ (with Computer and DeXipher™ Basic), 110V

PlexBio 100™ (with Computer and DeXipher™ Basic), 220V

IntelliPlex™ BMB Wash Station, 110V

IntelliPlex™ BMB Wash Station, 220V

DeXipher™ RU

DeXipher™ MD

BMB Assay Processing Set, 110V(Includes: Shaker/Incubator, Pump Set, Manifold Set, De-Magnetizer)

BMB Assay Processing Set, 220V(Includes: Shaker/Incubator, Pump Set, Manifold Set, De-Magnetizer)

Magnetic Stand (for Vials)

PlexBio 100™ Calibration Kit

128-Plex BMB for Protein (0-127)

128-Plex BMB for DNA (128-255)

BMB-Protein Coupling Kit (for 500k beads)

BMB-Nucleic Acid Coupling Kit (for 500k beads)

Biotin-PEG4-NHS

Streptavidin-Phycoerythrin

BMB Wash Buffer (10X)

IntelliPlex™ TORCH Plus IgG Kit (96)

IntelliPlex™ TORCH Plus IgM Kit (96)

IntelliPlex™ TORCH Plus IgG Avidity Kit (96)

IntelliPlex™ Down Syndrome Kit (96)

IntelliPlex™ Cytokine Panel 1 (15 plex)

IntelliPlex™ Cytokine Panel 2 (15 plex)

IntelliPlex™ HPV Genotyping Kit (96)

IntelliPlex™ KRAS G12/13 Mutation Kit (24)

IntelliPlex™ KRAS G12/13 Mutation Kit (96)

IntelliPlex™ BRAF V600 Mutation Kit (24)

IntelliPlex™ BRAF V600 Mutation Kit (96)

IntelliPlex™ HCV 1-6 Genotyping Kit (24)

IntelliPlex™ HCV 1-6 Genotyping Kit (96)

IntelliPlex™ EGFR Mutation Kit (24)

IntelliPlex™ EGFR Mutation Kit (96)

IntelliPlex™ Assay Kits

PlexBio develops nucleic acid- and protein-based IntelliPlex™ assay kits designed to save time, labor, and patient sample, resulting in fast, reliable results at very low cost. Each of these kits is optimized to test for multiple targets in a single well, up to 96 tests at a time.

IntelliPlex™ HPV Genotyping Kit (Cat. No. 82000)

Infection of human papillomavirus (HPV) genotypes that are high-risk for developing into cervical and other cancers tends to be symptomless until the cancers are advanced, making early detection and treatment of HPV infections crucial. DNA screening for 10 HPV types, including 20 high-risk and 10 low-risk types.

IntelliPlex™ TORCH Plus IgG, IgM, and IgG Avidity Kit (Cat. No. 81000, 81001, 81005)

TORCH is an acronym for a set of infections that can be passed from mother to fetus, leading to severe birth defects or fetal death. Detection of TORCH infections early in pregnancy allows for more effective treatment, or even prevention of perinatal infection. Detection of serum IgG, IgM, or IgG Avidity against Toxoplasma gondii, Rubella, CMV, HSV-1 and -2, Chlamydia trachomatis, and Parvovirus B19.

IntelliPlex™ KRAS G12/13 Mutations Kit (Cat. No. 81002)

KRAS-activating mutations are associated with mCRC, NSCLC and other tumors. The mutational status can serve as critical supporting information on treatment options. Detection of 12 KRAS mutations on codon 12 and codon 13, including G12D, G12C, G12S, G12R, G12A, G12V, G13D, G13C, G13S, G13R, G13A, and G13V.

IntelliPlex™ KRAS G12/13 Mutation Kit (Cat. No. 82003)

KRAS-activating mutations are associated with CRC/mCRC, NSCLC, and other cancer patient tumors. The mutational status can serve as critical supporting information on treatment options. Detection and differentiation of 12 KRAS mutations on codons 12 and 13, including G12D, G12C, G12S, G12R, G12A, G12V, G13D, G13C, G13S, G13R,G13A, and G13V

IntelliPlex™ BRAF V600 Mutation Kit (Cat. No. 82004)

BRAF-activating mutations are mainly associated with melanoma, CRC/mCRC, and other cancer patient tumors. Like KRAS, the BRAF mutational

status can serve as critical supporting information on treatment options. Detection and differentiation of six BRAF mutations on codon 600, including V600E, V600K, V600D, V600G, V600R, and V600M

IntelliPlex™ EGFR Mutation Kit (Cat. No. 82006)

Epidermal growth factor receptor (EGFR) mutations can be found in some NSCLC patient tumors. The mutational status can serve as critical supporting information on treatment options since some mutations are associated with sensitivity and others resistance to EGFR tyrosine kinase inhibitors (TKIs). Detection and differentiation of 22 EGFR mutations in exons 18, 19, 20, and 21, including the activating mutations (such as the G719S/C/A mutations in exon 18, the deletion mutations, e.g., Cosmic IDs 6223 and 6225 mutations, in exon 19, and the L858R mutation in exon 21) and the major TKI-resistance mutation, T790M, in exon 20.

IntelliPlex™ Cytokine Panels (Cat. No. 81003 and 81004)

Cytokines are a family of small proteins that play critical roles in intercellular communication and can be important for biomedical, preclinical, and clinical studies. Detection of cytokines IL-1a, IL-1b, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL23 p40, IL-12 p70, IL-13, IL-15, IL-17a, IL-18, IFNa2, IFNg, IP-10, MCP-1, MIP-1a, RANTES, TNFa, VEGF-A, Gro-a/KC, Leptin, CSF, GMCSF, Eotaxin, and MIP-1b.

IntelliPlex™ HCV Genotyping Kit (Cat. No. 82005)

Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus (HCV). Chronic infections increase the risk of developing chronic liver disease, cirrhosis and liver cancer. HCV is divided into six genotypes and each genotype requires custom tailored treatment. Screening the genotype before treatment is therefore necessary to determine the most appropriate approach for the patient. Detection of six major HCV genotypes (1, 2, 3, 4, 5, 6).

Page 12: Intelligent Multiplexing Solutions for Better Health...Intelligent Multiplexing Solutions for Better Health Intelligent Multiplexing Solutions for Better Health 6F-1, No. 351 Yangguang

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Tel: (02) 2627-5878Fax: (02) 2627-5979Email: [email protected]

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