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IntelliPlex Multiplexing Assay Workflow
IntelliPlex and Automated Systems IntelliPlex Gene Mutation Kits IntelliPlex Lung Cancer Panel PlexBio Product Portfolio 02 04 06 08 14 18 21 Technology Fast 500™ Asia Pacific 2020 Ranking Technology Fast 500™ Asia Pacific 2019 Ranking 13485 Precision Medicine Market Demands for Precise and Affordable Molecular Analysis Technology Molecular Commercialization of πCode™
Analyzing Kits Molecular Analysis Technology Clinical Validation of πCode™ Technology Invention of πCode™ MicroDiscs by PlexBio • Research Laboratories • Hospitals • Service Laboratories • Pharmaceutical Companies • Medical Device Developers Licensing PlexBio Is Among The Top 500 Fastest Growing Technology Companies In Asia Pacific PlexBio is a world-leading innovator in the field of molecular diagnostics. Based in Taiwan, the company has been recognized consistently to be among the top 500 technology businesses in Asia-Pacific for the past three years running. PlexBio is a world-leading IVD product inventor and manufacturer based in Taiwan.
We possess the state-of-the-art patented technology - IntelliPlex™ platform and Precision Image Code (πCode™) MicroDiscs. This core technology allows multiplex assays to be applied to a variety of clinical diagnostics, enabling precision medicine to become routine practice. We specifically focus on cancer diagnostics and monitoring, and have developed cancer panels covering over hundreds of gene mutations that can be simultaneously analyzed using noninvasive liquid biopsy from patients.
We are committed to continuing our innovation to provide the most advanced IVD products for precision medicine. 02 03 PlexBio™ 100 Fluorescent Analyzer Bright field Dark field Target X Target X Probe X πCode Target X Probe X SA-PE πCode Target X Probe X SA-PE πCode Biotin Amplification Hybridization Washing SA-PE Dispensing Detection Probe coupling Multiplexing Nucleic Acid Assay Immunossay Biotin Biotin Target N Sample Sample Biotin Biotin SA-PE SA-PE Antibody-Biotin Antibody Target N Probe N Probe N Target N Biotin Probe N Hybridization Sample (Biotinylated Amplicon) SA-PE SA-PE πcode πcode πcode πcode πcode πcode πcode 3 πCode Master Mix Thousands of unique patterns are labelled on πCode™ Automated Result Analysis Result analysis is always a critical step determining the outcomes of every single assay.
Some assays, for example NGS, can take up to days to analyze results, which would be unfavorable in some circumstance. With πCode™ assay, any successful hybridization of probes and their specific targets would emit fluorescence, which is detected and analyzed by fully automated PlexBio™ 100 Fluorescent Analyzer. PlexBio™ 100 Fluorescent Analyzer takes dark field and bright field images. The dark field images, which are used to detect fluorescence signals, are colocalized with the bright field images in order to identify the unique circular patterns imprinted on the πCode™ MicroDiscs with positive signals.
The system automatedly processes result interpretation and deliver result reports in 30 minutes. πCode™ System Overview πCode™ MicroDisc is an innovative molecular analysis technology combining the advance in nanotechnology and semiconductor technology. πCode™ MicroDiscs are made of silicon wafers and have an extremely tiny size of 40 μm in diameter. Each πCode™ MicroDisc has an assigned distinct circular image pattern imprinted on its surface, and a specific capture agent, which can be either nucleic acid probe or antibody, conjugated to its surface. They are manufactured to generate more than 85,000 distinct circular image patterns for multiplexing applications. πCode™ MicroDiscs tagged with different capture agents are pooled, enabling specific detection of multiple analytes in one-well reaction. 04 05 Manual Extraction Thermal Cycler IntelliPlex™ 1000 πCode Processor PlexBio™ 100 Fluorescent Analyzer TRIO 240 Automated Nucleic Acid Extractor IP5000 Automation System EXTRACTION AMPLIFICATION HYBRIDIZATION to SIGNALING DETECTION STEP 01 STEP 02 STEP 03 STEP 04 IntelliPlex Multiplexing Assay Workflow Current Integrated Systems Future Automated Systems 06 07 SPECIFICATIONS Model IW100 OPERATION CONDITIONS Temperature/ Humidity 18° C ~ 32° C (64° F ~ 90° F)/20 ~ 80% RH, non-condensing Altitude Up to 2000 meters (6561 ft) above mean sea level Storage Conditions -10° C ~ 70° C (14° F ~ 158° F)/10 ~ 80% RH, non-condensing PERFORMANCE Supported plates 96-well plate (Plexbio; Cat. No. 80025 or Greiner Bio-one; Cat. No. 655101) Processing time (full plate) 3 ~ 8 min (one-time wash) Shaking Max. rate: 1200rpm Incubator Temperature range from RT+5° C to 60° C Safety Plate position sensor and door sensor Temperature accuracy ± 0.5° C Temperature uniformity 1° C Shaking accuracy ≤ 10% Dispensing accuracy ≤ ± 6% Dispensing uniformity ≤ 4% CV MicroDisc loss Around ≥ 75% of MicroDiscs retained after whole processes. Residual volume ≤ 5 μl/well (Measured under completed wash processes) PHYSICAL CHARACTERISTICS Power 100-240V, 50-60Hz, 250W Dimensions Without Bottle Carrier:(W)408mm*(D)540mm*(H)470mm With Bottle Carrier: (W)554mm*(D)540mm*(H)470mm Weight 38 kg (84 lbs) Fuse rating T 5A H 250V SPECIFICATIONS Model PB100 OPTICS Coding Image Pattern Optics (Excitation) LED Optics (Detection) CCD imager A/D resolution 14 bits Focus Lens 10x magnification PERFORMANCE Supported plates 96-well plate (Plexbio; Cat. No. 80025 or Greiner Bio-one; Cat. No. 655101) πCode Classification Accuracy ≥ 98% πCode Recognition Precision (CV) ≤ 2.5% MFI Precision (CV) ≤ 1.5% Daily Start-Up ≤ 15 min Reading Time 1 well ≤ 50 sec PHYSICAL CHARACTERISTICS Power 100-240V, 50-60Hz Dimensions 27.3 cm W x 54 cm D x 44.1 cm H Weight 25 kg (55.0 lbs) Connection USB and Ethernet IntelliPlex™ 1000 πCode™
Processor The IntelliPlex™ 1000 πCode Processor is a fully automated workstation designed for πCode™ processing.Its 4-in-1 capabilities include πCode MicroDisc hybridization, washing, incubation, and labeling. Instrument software includes built-in modes for PlexBio assays and the ability to program customized molecular or immunoassays on the 7-inch industrial touchscreen panel. Touchscreen ✚ Intuitive a 7-inch industrial panel ✚ Real-time display of processing status Shaking & Incubation ✚ Adjustable time and temperature Fluorescence Labeling ✚ Automated fluorescence reagent dispensing Washing ✚ Minimization of MicroDisc loss with movable magnetic plate ✚ Automatic rinsing prevents tube blocking CAT. 80033 PlexBio™ 100 Fluorescent Analyzer The PlexBio™ 100 Fluorescent Analyzer is part of a multiplex suspension array platform which utilizes Precision Image Code (πCode™ ) MicroDisc technology for multiplexing both molecular and immunoassays. The PlexBio™ 100 Fluorescent Analyzer is a robust optical imaging system that decodes πCode MicroDiscs through fluorescence detection and highcontrast imaging. Compatibilty ✚ Compatible for detecting both molecular and immunoassay Convenience ✚ Easy to maintain and no fluidic system that reduces the risk of contamination Cost-effectiveness ✚ Multiplexing improves productivity by reducing time, reagent, and sample volume Capacity ✚ A high-throughput system analyzes up to 100-200 targets simultaneously in a single well CAT. 80000 08 09 TRIO 240 Automated Nucleic Acid Extractor The IntelliPrep TRIO 240 System is an easy-to-use liquid handling workstation from nucleic acid (NA) extraction to PCR setup for downstream applications. It provides nucleic acid purification from a wide range of primary sample types, and can process up to 24 samples in a single run. CAT. 80042 Product Highlights Multifunctional Workstation ✚ Integrated with extraction, quantification, and PCR set up Fully Automated Program ✚ One-step sample scanning for all subsequent automated procedure Minimum Process Time ✚ Significantly reduces operation time and human error, and compeletes the process in 85 minutes Built-in UV Sterilization ✚ Eliminates the risk of cross-contamination for reliable assay results TRIO 240 Workflow QR Code Reading for Assays Auto-Sample Scanning Nucleic Acid Extraction Nucleic Acid Quantification PCR Plate Setup SPECIFICATIONS Model TRIO 240 Throughput Up to 24 samples per run Storage Conditions -10~70 ° C, 10 ~ 80% RH non-condensing Operation Conditions 15~35 ° C, 10 ~ 80% RH non-condensing Extraction Performance Pipette Type Fixed 24 channel Pipette Range 50 μL~1000 μL Pipette Consistency 50 μL < 5% ; 100 μL < 1% ; 500 μL < 0.5% Pipette Accuracy 50 μL < ±7% ; 100 μL < ±3% ; 500 μL < ±2.5% Temperature Control Range Ambient ~ 95° C Temperature Control Accuracy ±5℃ at 60℃ Temperature Control Uniformity 8℃ at 60℃ Robot Arm Positioning Accuracy ±0.1 mm Processing Time 85 minutes, varies by kit Physical Characteristics Power 100-240V, 50-60Hz Dimensions 660 mm x 830 mm x 759 mm (WxDxH) Weight 110 kg (242.5 lbs) 10 11 IP5000 Automation System Automated integrating workstations from PCR amplification to πCode detection and analysis, the precise liquid handling modules effectively simplified assay workflow without repeatedly moving in and out for reaction plates, reducing human error risks and cross-contaminations to achieve reliable assay performance. CAT. 80041 PRODUCT HIGHLIGHTS ✚ Seamless workflow from PCR amplification, Hybridization, Washing, Signaling to πCode Detection and Analysis ✚ Automated Reporting ✚ Reduce 90% Hands-on Time ✚ Precise Liquid Handling ✚ High-throughput for 96-sample reporting in 4 hours ✚ Save Time, Labor, Reagents and Samples PATENTS ✚ US9063044B2 (Magnetic aggregating and washing) ✚ US10436776B2 (Methods and systems for selection of detection area) ✚ US10019815B2 (Methods and systems for image differentiated multiplex assays) Automated Reporting Fully Data Traceability DeXipher Network Configuration Office Specimen reception Lab Lab Specifications Model IP 5000 Operation Temperature 15° C~32° C Storage Conditions -10° C~70° C/ 10~80% RH non-condensing Processing Time (Hybridization, Washing, SA-PE Signaling, Detection) ≤ 120min Dispensing accuracy Accuracy: 150uL ± 5% Dispensing uniformity Precision: CV ≤ 3% Throughput 96 Samples Assay Types 96 well Plate Supported Plate Types • U-bottom plate • F-bottom plate • PCR plate 12 13 DNA RNA KRAS BRAF EGFR NRAS PIK3CA HER2 AKT1 MEK1 ALK ROS1 RET/ NTRK1 MET Colorectal V V V V V Lung V V V V V V V V V V V V Pancreas V Endometrial V V V V Melanoma V V Thyroid V Breast V Gene Cancer type IVD approval labeled in red IntelliPlex™ NRAS Mutation Kit The IntelliPlex™ NRAS Mutation Kit is a qualitative molecular assay for the detection of clinically actionable somatic mutations on exon 2-4 of the NRAS gene. A total of 33 mutations can be analyzed in a single well by using πCode MicroDisc and the SelectAmp PCR Technologies. IntelliPlex™ BRAF V600 Mutation Kit The IntelliPlex™ BRAF Mutation Kit is a qualitative molecular assay for the detection of clinical actionable somatic mutations on exon 15 of the BRAF gene. A total of 7 mutations can be analyzed in a single well by using πCode MicroDisc and SelectAmp PCR Technologies. Product Highlights ✚ Single-well multiplex detection ✚ High sensitivity (0.5-2.9 % LoD) ✚ Low DNA sample input (10ng) ✚ <5 hours turnaround time for 96 samples (sample extraction not included) Product Highlights ✚ Single-well multiplex detection ✚ High sensitivity (0.29-1.57 % LoD) ✚ Low DNA sample input (10ng) ✚ <5 hours turnaround time for 96 samples (sample extraction not included) CAT. 82020 CAT. 82004 PlexBio is Your Best Partner for Precision Medicine Probes are designed to pick up the mutations of the genes known to be associated with cancers. Multiplexing is designed to analyze selected targets in one reaction. Mutation Panel by IntelliPlex™ 14 15 IntelliPlex™ KRAS Mutation Plus Kit The IntelliPlex™ KRAS Mutation Plus Kit is a qualitative molecular assay for the detection of clinically actionable somatic mutations on exon 2-4 of the KRAS gene. A total of 27 mutations can be analyzedd in a single well by using πCode MicroDisc and the SelectAmp PCR Technologies. IntelliPlex™ ALK Rearrangement Kit The IntelliPlex™ ALK Rearrangement Kit is a qualitative molecular assay for the aberrant gene fusions detection on EML4-ALK, KIF5B-ALK, and TFG-ALK transcripts. The kit utilizes one-step RTPCR and PlexBio’s core πCode technology which enables 24 ALK variants to be identified in a single well using RNA samples extracted from formalin-fixed paraffin-embedded tissues (FFPET). Product Highlights ✚ Single-well multiplex detection ✚ High sensitivity (0.36-1.83 % LoD) ✚ Low DNA sample input (10ng) ✚ <5 hours turnaround time for 96 samples (sample extraction not included) Product Highlights ✚ Detect 24 ALK fusion variants in one well test ✚ High sensitivity (5~1209 copies LoD) ✚ Only ≥50ng RNA sample required ✚ <5 hours turnaround time for 96 samples (sample extraction not included) CAT. 82022 CAT. 82023 IntelliPlex™ ROS1 Rearrangement Kit The IntelliPlex™ ROS1 Rearrangement Kit is a qualitative molecular assay for the aberrant gene fusions detection on ROS1 gene. The kit utilizes one-step RT-PCR and PlexBio’s core πCode technology which enables 14 ROS1 fusion variants to be identified in a single well using RNA samples extracted from formalin-fixed paraffin-embedded tissues (FFPET). IntelliPlex™ RET/NTRK1 Rearrangement Kit The IntelliPlex™ RET/NTRK1 Rearrangement Kit is a qualitative molecular assay for the aberrant gene fusions detection on RET and NTRK1 genes. The kit utilizes one-step RT-PCR and PlexBio’s core πCode technology which enables 14 RET and NTRK1 fusion variants to be identified in a single well using RNA samples extracted from formalin-fixed paraffin-embedded tissues (FFPET). Product Highlights ✚ Detect 14 ROS1 fusion variants in one well test ✚ High sensitivity (≤ 5~120 copies LoD) ✚ Only ≥50ng RNA sample required ✚ <5 hours turnaround time for 96 samples (sample extraction not included) Product Highlights ✚ Detect 14 RET and NTRK1 fusion variants in one well test ✚ High sensitivity (12~486 copies LoD) ✚ Only ≥50ng RNA sample required ✚ <5 hours turnaround time for 96 samples (sample extraction not included) CAT. 82024 CAT. 82025 16 17 EGFR Mutations KRAS Mutations NRAS Mutations BRAF Mutations PIK3CA Mutations MEK1 Mutations AKT1 Mutations HER2 Mutations ALK Mutations ROS1 Mutations RET Mutations NTRK1 Mutations MET ex14 Mutations Liquid Biopsy FFPE Tissue IntelliPlex™ Lung Cancer Panel-cfDNA IntelliPlex™ Lung Cancer Panel-DNA The IntelliPlex™ Lung Cancer Panel is a qualitative molecular assay for the detection of mutations that are clinically actionable for targeted therapy for non-small cell lung cancer (NSCLC). The assay detects 74 DNA mutations in the KRAS, NRAS, PIK3CA, BRAF, EGFR, HER2, AKT1, MEK1 genes derived from plasma or FFPE of patients with NSCLC. CAT. 82030 CAT. 82032 Comprehensive Coverage ✚ 74 mutations of KRAS,NRAS, PIK3CA, BRAF, EGFR, HER2, MEK1 and AKT1 genes High Sensitivity ✚ cfDNA: 0.1-2.32% LoD FFPE DNA: 1~2.5 % LoD Low Sample Input ✚ DNA: ≥10ng Quick Turnaround ✚ From sample to report in less than 5 hours ✚ Comprehensive Coverage 74 mutations of KRAS, NRAS, PIK3CA, BRAF, EGFR, HER2, MEK1 and AKT1 genes 28 gene fusions of ALK, ROS1, RET, NTRK1 and MET genes ✚ High Sensitivity cfDNA : 0.1~2.32 % LoD cfRNA : 10~89 copies LoD FFPE DNA : 1~2.5 % LoD FFPE RNA : 10~89 copies LoD ✚ Low Sample Input DNA : ≥10ng RNA : ≥50ng ✚ Quick Turnaround From sample to report in less than 5 hours First Choice for Lung Cancer Detection & Management IntelliPlex™ Lung Cancer Panel Kit 18 19 IntelliPlex™ Lung Cancer Panel-cfRNA IntelliPlex™ Lung Cancer Panel-RNA The IntelliPlex™ Lung Cancer Panel is a qualitative molecular assay for the detection of variants that are clinically actionable for targeted therapy selection in non-small cell lung cancer (NSCLC). The assay detects 28 variants of the ALK, ROS1, RET, NTRK1 and MET genes using cell-free RNA derived from plasma or FFPE of patients with NSCLC. CAT. 82031 CAT. 82033 Comprehensive Coverage ✚ 28 gene fusions of ALK, ROS1, RET, NTRK1 and MET genes High Sensitivity ✚ cfRNA: 10-89 copies LoD FFPE RNA: 10-89 copies LoD Low Sample Input ✚ RNA: ≥50 ng Quick Turnaround ✚ From sample to report in less than 5 hours PlexBio Product Portfolio Item Cat. NO. Product Name Single Gene Mutation Kits 82004 IntelliPlex™ BRAF V600 Mutation Kit 82006 IntelliPlex™ EGFR Mutation Kit 82020 IntelliPlex™ NRAS Mutation Kit 82021 IntelliPlex™ PIK3CA Mutation Plus Kit 82022 IntelliPlex™ KRAS Mutation Plus Kit 82023 IntelliPlex™ ALK Rearrangement Kit 82024 IntelliPlex™ ROS1 Rearrangement Kit 82025 IntelliPlex™ RET/NTRK1 Rearrangement Kit Lung Cancer Panel Kits 82030 IntelliPlex™ Lung Cancer Panel-cfDNA 82031 IntelliPlex™ Lung Cancer Panel-cfRNA 82032 IntelliPlex™ Lung Cancer Panel-DNA 82033 IntelliPlex™ Lung Cancer Panel-RNA Infectious Disease Kits 82303 IntelliPlex SARS-CoV-2 Detection Kit 82304 IntelliPlex™ SARS-CoV-2/Flu Kit 82306 IntelliPlex™ SARS-CoV-2 Detection Test Kit 82307 IntelliPlex™ SARS-CoV-2 Variant Analysis Kit 82302 IntelliPlex™ HPV Genotyping Kit 20 21 We are committed to the delivery of safe, high quality products and services to yield improved healthcare options for our customers and their patients. 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Amplification kitAmplification kit1st Apr 2022