Empower Your Molecular Diagnostics: Innovative qPCR Solutions

Empower your molecular diagnostics: The future is here Innovative qPCR solutions for molecular diagnostics For In Vitro Diagnostic Use. qPCR Putting you in control of molecular diagnostics 3 Which system fits your needs? 6 QuantStudio 7 Pro Dx Real-Time PCR System (CE-IVD, IVDR) 7 QuantStudio 5 Dx Real-Time PCR System (CE-IVD, IVDR) 9 Diomni Enterprise Software (CE-IVD, IVDR) 11 Services and support 13 TaqPath master mixes for real-time PCR 15 MicroAmp qPCR plastics 17 Commercial supply partnerships for MDx assay developers 19 Contents For In Vitro Diagnostic Use. For In Vitro Diagnostic Use. At Thermo Fisher Scientific, we understand that the future of clinical diagnostics is molecular testing. Molecular diagnostics (MDx) tests have become indispensable tools, and the use of molecular-based assays will continue to grow in number and importance for infectious disease, oncology, and other vitally important diagnostic tests. Assay developers face many complex challenges as molecular testing continues to rapidly evolve. The need for solutions that are flexible and efficient, and that support the delivery of high-quality results, is paramount. We designed real-time PCR (qPCR) in vitro diagnostic (IVD) solutions with you in mind. Our innovative and complete workflow enables you to effectively respond to the assay design challenges you face in developing and commercializing products. Since 2008, we have been supporting your qPCR needs with a full workflow for assay developers. We now offer a comprehensive qPCR diagnostics portfolio, including instruments, master mixes and consumables, primers and probes, software solutions, and service and support. Instruments: Powered by proven technology, the Applied Biosystems™ QuantStudio™ 7 Pro Dx Real-Time PCR System is an advanced, stand-alone qPCR platform that is versatile, highly expandable, and easy to use for a smart, assay-driven qPCR workflow, from setup to report. The compact and flexible Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR System is designed to streamline workflows and minimize training needs so you can get clinical answers quickly. Putting you in control of molecular diagnostics Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics 33 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics All high-quality Applied Biosystems™ QuantStudio™ IVD real-time PCR systems offer a small footprint, simple workflow and software, and world-class service and support plans Software solution: Designed to improve your lab’s efficiency, Applied Biosystems™ Diomni™ Enterprise Software is an enterprise workflow solution that reduces time-to-results with interpretation, automated quality control, and configurable reporting. Diomni software also provides a scalable solution by connecting to multiple instruments and supporting multiple concurrent users with centralized data management. In addition to integrating with QuantStudio real-time PCR systems, Diomni software reduces manual steps through integration with your laboratory information system (LIS)/laboratory information management system (LIMS), and the Thermo Scientific™ KingFisher™ Apex Dx sample prep instrument. Diomni software is a flexible solution to support a variety of testing needs with traceability to help you meet compliance standards. Service and support: We enable peace of mind with the assurance that our diagnostic solutions are all backed by a proven, global leader in molecular testing; a reliable, single-source supplier with a robust supply chain; and exceptional service and support. For In Vitro Diagnostic Use. Discover how we can put you in control of molecular diagnostics. 4 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Applied Biosystems™ TaqPath™ real-time PCR master mixes deliver confidence and reliability for your most demanding molecular diagnostic development and testing needs Master mixes and consumables: Thermo Fisher Scientific is your trusted partner, from assay development, through validation and testing, to ultimate production. We offer a complete qPCR ecosystem that includes a broad range of custom primers and probes, GPR and GMP Applied Biosystems™ TaqPath™ master mixes, and PCR plastics. Optimized to work synergistically, our flexible, high-performance solutions enable optimal PCR performance, giving you complete control and accelerating assay development, so you can bring high-quality diagnostic tests to market faster. TaqPath master mixes are designed to meet the needs of clinical diagnostic testing and are available for qPCR and one-step reverse transcription qPCR (RT-qPCR) in singleplex and multiplex formats. Each reagent is manufactured in an ISO 13485–registered facility and rigorously tested to help ensure lot-to-lot reproducibility for Cq consistency and wide dynamic range. Applied Biosystems™ MicroAmp™ PCR plastics are engineered to reduce cross-contamination and promote optimal heat transfer. Applied Biosystems™ MicroAmp™ General Purpose Laboratory Equipment (GPLE) reaction plates are ideal for use in diagnostic procedures and certified in an ISO 13485–registered facility to be free of DNA, RNase, and PCR inhibitors. For Laboratory Use. 5 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Which system fits your needs? QuantStudio IVD real-time PCR systems For In Vitro Diagnostic Use. QuantStudio 7 Pro Dx system QuantStudio 5 Dx system Formats 96-well, 0.2 mL 96-well, 0.2 mL 384-well User-interchangeable blocks Yes No Colors Up to 6 colors (21 filter combinations) Up to 6 colors (21 filter combinations) Touchscreen 21.5 cm 21.5 cm Applied Biosystems™ VeriFlex™ Blocks temperature control Yes, 6 zones* Yes, 6 zones Security, auditing, electronic signature (SAE) Yes Yes Dimensions (H x W x D) 55 x 34 x 53 cm 40 x 27 x 50 cm Weight 38 kg 26 kg Regulatory status CE-IVD, IVDR; US-IVD CE-IVD, IVDR; US-IVD Block format Customer-interchangeable 384-well and 96-well, 0.2 mL Fixed 96-well, 0.2 mL Software Diomni software solution RUO, IUO, and IVD modes Diomni software solution RUO, IUO, and IVD modes Integration APIs for hardware integration Diomni software for LIMS compatibility Diomni software for LIMS compatibility Footprint Benchtop (55 x 34 x 53 cm); stand-alone Benchtop (40 x 27 x 50 cm); computer required Performance Up to 6 colors, 21 filter combinations; 6-zone VeriFlex Block temperature control* Up to 6 colors, 21 filter combinations; 6-zone VeriFlex Block temperature control Standardization and security Security, auditing, electronic signature Security, auditing, electronic signature * 96-well block only . 6 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics The QuantStudio 7 Pro Dx Real-Time PCR System is an In Vitro Diagnostic Regulation (IVDR)–compliant qPCR platform that combines modern hardware and software in a compact footprint, enabling assay developers and molecular diagnostics labs to achieve exceptional efficiency, smarter productivity, and higher accuracy from their workflow. The system enables flexible throughput with interchangeable 96-well and 384-well blocks, and it features an RUO mode for development and an IVD mode for routine diagnostics. Smart instrument, smart features, and smart productivity enabled by connectivity • IVDR—meets IVDR requirements and technical documentation requirements • Results you can trust—detect diff erences in target quantity as small as 1.5-fold in singleplex reactions, and obtain 10 orders of magnitude of linear dynamic range • Simple, powerful software—users can set up a run, lay out assays, control the instrument, and analyze plates within a single, easy-to-use touchscreen interface; no computer is needed • Proven performance—over 10 years of clinical real-time PCR instrument manufacturing • Effi cient—shorter run times compared to those with previous QuantStudio Dx systems, minimal maintenance, and compatibility with existing plastic consumables • Enhanced security—SAE functionalities that assist with compliance and have the ability to support multiple clients; maintain centralized SAE settings that can be applied to multiple instruments on the same network, allowing better control for your IT department • Instrument monitoring—use a mobile app to check instrument availability and monitor run progress • Voice command—enables selected hands-free operation by voice control (Alexa™ services) • Smart Help and Remote Support—Smart Help enables you to report issues or request instrument services to reduce downtime; remote access to device for troubleshooting Take command of assay design QuantStudio 7 Pro Dx Real-Time PCR System (CE-IVD, IVDR) Automatable The application programming interface (API) enables integration with a robotic plate mover, a liquid handler, and a third-party system. The QuantStudio 7 Pro Dx instrument is a stand-alone system The graphical user interface (GUI) enables an end-to-end IVD workflow, offering the following features: • Run setup with predefi ned assays • Instrument controls • Run monitoring • Post-run data analysis, exporting, and reporting • Maintenance and support • SAE features to assist with 21 CFR Part 11 requirement The instrument is Internet of Things (IoT)—enabled (Thermo Fisher™ Connect Platform) • Voice-activated controls • Smart support • Remote run monitoring Routine testing at scale Diomni software supports the use of multiple instruments and users with centralized data management. Take command of assay design For In Vitro Diagnostic Use. Learn more at thermofi sher.com/quantstudio7prodx 7 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics E-signature and data approval SAE software records test events, dates, user names, and user roles and activity performed, for documentation and archiving purposes. Test results Report records details for documentation, archiving, and review-at-a-glance needs, including experiment name, barcode, file name, time stamps (creation, run start, run finish, duration, and modifications), instrument name, serial number, experiment type, results summary, plate layout image, standard curves, results table, and QC summary. Cybersecurity The system has passed penetration testing that fulfills cybersecurity guidance from US regulatory bodies. Features to maintain data quality and integrity Specifications QuantStudio 7 Pro Dx system Sample capacity 96-well, 384-well Reaction volume 96-well, 0.2 mL block: 10–100 μL; 384-well block: 5–20 µL Excitation source Bright white LED Filter or color combinations 6 decoupled filters, CMOS camera Excitation/detection range 450–680 nm/500–730 nm Multiplexing 5-plex with 1 passive reference; 6-plex with no passive reference Maximum block ramp rate 6.5°C/sec Average sample ramp rate 3.66°C/sec Temperature uniformity ±0.5°C Temperature range 4–99.9°C Heating and cooling method Peltier Independent temperature zones 6 VeriFlex Blocks zones (5°C zone-to-zone)* Chemistries Fast and standard Run time <30 min (fast mode) Compatible dyes Applied Biosystems™ FAM™, SYBR™ Green, VIC™, ABY™, NED™, TAMRA™, JUN™, ROX™, Mustang Purple™, and cyanine 5 dyes SAE features Included Automation-compatible Yes Footprint (H x W x D) 55 x 34 x 53 cm Weight 38 kg * VeriFlex Block zones are only applicable for the 96-well, 0.2 mL block. Automated quality control Run data are systematically analyzed based on predefined settings pertaining to each test, such as validity of internal positive and negative controls. Assessment for failed samples can be configured based on assay characteristics. Reagent tracking The system stores and archives information about reagents used with each test, including lot number and expiration date, with each run. Archived files can be retrieved when required to track samples that were tested with a given set of reagents. Sample tracking The system tracks sample name and type; captures critical sample data, with parameters customizable to fit the laboratory’s needs; and enables laboratories to more easily track samples associated with a particular plate, a set of reagents, a run date and time, and data files. For In Vitro Diagnostic Use. 8 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics An easy-to-use, reliable, IVD qPCR system to put you in control QuantStudio 5 Dx Real-Time PCR System (CE-IVD, IVDR) An instrument with premium performance at an aff ordable price • IVDR—updated to meet IVDR requirements and technical documentation requirements • Results you can trust—detect diff erences in target quantity as small as 1.5-fold in singleplex reactions, and obtain 10 logarithmic units of linear dynamic range • Simple, powerful software—allows users to set up a run, lay out assays, control the instrument, and conduct plate analysis within a single, easy-to-use software interface • Designed with the clinic in mind—an interactive diagnostic instrument, with short run times and minimal maintenance, that uses existing plastic consumables • Security—SAE functionalities and the ability to support multiple clients, plus centralized SAE settings that can be applied to multiple instruments on the same network, allowing better control for your IT department • Peace of mind—the IVD test menu allows only authorized tests to be run through IVD mode, helping to reduce the risk of unauthorized use and accidental or intentional misuse * Test development mode is for Research Use Only. Designed to simplify workfl ows and minimize training needs, the QuantStudio 5 Dx Real-Time PCR System can help you get to your clinical answers quickly by fi tting seamlessly into your established workfl ow. This compact, fl exible system provides confi dence in performance and supports both development and IVD modes. For In Vitro Diagnostic Use. • Flexibility you need—diagnose or develop, the choice is yours with software options that guide you through every step of test development* and IVD modes • Maximize benchtop space—a compact instrument footprint and a plate loading drawer at the front • Superior support—services and support are available globally by highly skilled, customer-focused staff • QuantStudio system performance—the reliability, sensitivity, and accuracy you expect, coupled with an intuitive and simple-to-use interface that allows users of any experience level to easily operate the system Learn more at thermofi sher.com/quantstudio5dx 9 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Specifications QuantStudio 5 Dx system Sample capacity 96-well Reaction volume 96-well, 0.2 mL block: 10–100 μL Excitation source Bright white LED Filter or color combinations 6 decoupled filters, CMOS camera Excitation/detection range 450–680 nm/500–730 nm Multiplexing 5-plex with 1 passive reference; 6-plex with no passive reference Maximum block ramp rate 6.5°C/sec Average sample ramp rate 3.66°C/sec Temperature uniformity ±0.4°C Temperature range 4–99.9°C Heating and cooling method Peltier Independent temperature zones 6 VeriFlex Blocks zones (5°C zone-to-zone) Chemistries Fast and standard Run time <30 min Compatible dyes FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, and cyanine 5 dyes SAE features Included Automation-compatible No Footprint (H x W x D) 40 x 27 x 50 cm Weight 26 kg Features to help maintain quality and security Maintenance and calibration reports Records are updated automatically with maintenance and calibration events and can be printed on demand, documenting that the system has been maintained and calibrated to vendor specifications. Reagent tracking The system stores and archives information about reagents used with each test, including lot number and expiration date, with each run. Archived files can be retrieved when required to track samples that were tested with a given set of reagents. Sample tracking The system tracks sample name and type; captures critical sample data, with parameters customizable to fit the laboratory’s needs; and enables laboratories to more easily track samples associated with a particular plate, a set of reagents, a run date and time, and data files. E-signature history SAE software records test events, dates, user names, and user roles and activity performed, for documentation and archiving purposes. Experimental results Report output records details for documentation, archiving, and review-at-a-glance needs, including experiment name, barcode, file name, time stamps (creation, run start, run finish, duration, and modifications), instrument name, serial number, experiment type, results summary, plate layout image, standard curves, results table, QC summary plate, set of reagents, run date and time, and data files. For In Vitro Diagnostic Use. 10 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Streamline your lab workflow Diomni Enterprise Software Single encapsulation for assay workflow into one setup file: • Define the assay-specific run protocol, QC parameters, analysis settings, and result interpretation in one place—start in development phase, iteratively adjust for verification and validation, and submit your validation evidence with your assay submission • Choose the workspace designed specifically for your assay stage—each assay has a development status that can be used as your assay moves through the development process by choosing the RUO/IUO/IVD workspace that corresponds to each stage; functionalities in each workspace are optimized to support the matching objectives – RUO workspace—support iterative changes to the assay definition during the assay development phase; routine RUO tests – IUO workspace—support verification and validation runs for product development – IVD workspace—support routine testing for IVD tests • Expand test menu with speed—assays may be added to the system without requiring a software upgrade Assay-driven runs: • Use of predefined protocols to reduce time and error in run setup • Result interpretation according to your assay and automated QC saves time and effort for data review • Problematic data callout and QC tools make data review quicker and easier Easily integrated into development workflows: • Self-certify—assays can be published in Diomni software to lock down parameters and prevent user error when ready for routine testing and clinical trials, and after regulatory approval • Customized data input and output—make data transfer between LIS simple and flexible • Configurable reporting—tailor the PDF report to your needs • Integrate with LIS/LIMS—reduce manual steps to transfer data through configurable and automated sharing of results; additional traceability through ASTM communication to receive sample and test information available with full integration • IT friendly—the client server deployment model will enable your lab to maintain the software with ease and manage your lab in a secured, centralized location Specifications: • Microsoft™ Windows™ 10 or Windows™ 11 operating system • Supported browsers: Google™ Chrome™, Microsoft™ Edge™, Apple™ Safari™ (OS X), and Mozilla™ Firefox™ • Client server model designed for setup on local network • SAE Administrator Console Dx Software v1.2 • Instrument compatibility: Applied Biosystems™ QuantStudio™ 7 Pro series and QuantStudio™ 5 series real-time PCR systems Diomni software makes assay design on QuantStudio instruments more efficient, from development and verification to validation and launch. For In Vitro Diagnostic Use. Learn more at thermofisher.com/diomni 11 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Develop your assay, then run it with ease using the Diomni software workspaces Reduce time-to-market with the assay developer workflow in Diomni software Development Sample-to-report workflows Assay definition management IUO Investigational* RUO Research IVD In vitro diagnostic Feasibility Early to mid-development Validation Late-development verification Submission Launch Develop ADF Validate ADF Release ADF ADF Lock down ADF Obtain approval For In Vitro Diagnostic Use. * Investigational use only. Performance evaluation is only available upon request. Each instrument is equipped with a security, audit, and electronic signature (SAE) module to assist in compliance with regulatory requirements that involve a quality management system (QMS), GMPs, cybersecurity, and electronic records and signatures. • Secure access to instruments and data • Role-based permissions for different lab personnel You’re in control of assay design with the Diomni software self-certifying process to seamlessly transition through the test development stages. Once your assay has obtained approval for IVD use, the ADF can be locked and distributed as a final product for easy plug-and-play use. Your customers will reduce setup time and reduce error using your supplied IVD-labeled ADF. Security features fit for molecular diagnostics 12 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics For In Vitro Diagnostic Use. Get started with our global customer concierge services* Count on our dedicated customer concierge services for an exceptional and seamless experience implementing your QuantStudio real-time PCR IVD systems. From order placement through installation and training, our team is here to streamline and simplify the process by: • Preparing your laboratory space for a successful installation by providing critical documentation and checklists • Connecting your IT department with our IT specialists to help ensure an easy and secure network connection, so you can take advantage of cutting-edge features and advanced digital support • Coordinating instrument installation with a highly skilled field service engineer (FSE) • Scheduling interactive SmartStart Orientation training with an experienced field application scientist (FAS) * Concierge services are available in certain geographies. A standard of support that’s a cut above Thermo Fisher Scientific offers a comprehensive range of services and support to keep your QuantStudio real-time PCR IVD systems performing at peak level. Your instrument purchase comes with a standard 1-year factory warranty, customer concierge services, SmartStart Orientation, and an advanced digital service ecosystem built right into the instrument. Extended warranty coverage is also available at the time of purchase for total peace of mind. SmartStart Orientation enables your success Both QuantStudio 5 Dx and QuantStudio 7 Pro Dx Real-Time PCR Systems come with SmartStart Orientation to help your team quickly become proficient using the new software features and instrumentation. Led by an experienced FAS, this interactive course is a 1-day instrument- and software-based training that covers the principles of quantitative real-time PCR and how to use the QuantStudio instrument, Diomni software, and SAE features. The course will cover the following topics: • Proper experimental technique • Basic workflow • Software features and data analysis features • Discussion of instrument maintenance • Certificate of Training Completion for up to three users Keep advancing with new technology. We’ve got your back. Get superior service and support to maximize your investment 13 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics For In Vitro Diagnostic Use. Digital services and support ecosystem and on-demand support at your fi ngertips Your new QuantStudio 7 Pro Dx Real-Time PCR System is equipped with a state-of-the-art ecosystem of digital services and support so you can access our network of over 2,000 trained professionals at the touch of a button. With Smart Help you can easily share log and run files to speed up service troubleshooting and, if needed, request a service visit. Remote Support features enable our technical team to see your instrument in real time and interact with you on the instrument screen to resolve issues virtually. Find out how our digital support helps resolve up to 70% of cases in minutes, not days, enabling you to focus on your next scientific breakthrough. thermofisher.com/digitalserviceecosystem Comprehensive warranty and service plans to protect your investment Choose from a range of extended-coverage service plans to meet your budget and needs. In addition to the standard 1-year warranty, these plans offer: • Preventive maintenance • Access to advanced troubleshooting features, including Smart Help and Remote Support • Prioritized response time To build your personalized service quote, go to thermofisher.com/serviceselector Enjoy premium coverage with our premier service plan The Applied Biosystems™ AB Platinum™ plan is our top-tier total solution designed not only to optimize instrument performance and uptime, but also to provide a seamless experience and prompt resolutions. Key features of the AB Platinum plan include: • 98% uptime guarantee* • Comprehensive repair coverage • Rapid-response on-site support** • Priority Technical Support† • Qualifi cation services • Digital remote support • Additional FAS training (2-hour virtual consultation) Find out more about the AB Platinum service plan at thermofisher.com/abplatinum * Terms and conditions apply. For complete details, go to AB Platinum terms and conditions. ** Rapid-response on-site support within the next business day is subject to regional availability. † Priority Technical Support is available in the English language only. 98% uptime guarantee with the AB Platinum service plan* 70% remote resolution using Smart Help and Remote Support features Learn more at thermofi sher.com/instrumentservices 14 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics TaqPath master mixes for real-time PCR Delivering confidence and performance TaqPath master mixes are designed to deliver confidence and performance for even your most demanding clinical applications. With over 15 years of leadership in clinical real-time PCR, we are committed to providing trusted, versatile, and innovative tools. All TaqPath qPCR master mixes are: • Designed using fluorogenic 5´ nuclease chemistry • General purpose reagents (GPRs) registered with the US FDA • Manufactured in ISO 13485–certified facilities under CGMP • Supported by a comprehensive compliance document package • Labeled “For Laboratory Use” applications • Quality controlled to help ensure lot-to-lot consistency • Ready for IVD assay development and regulatory body submission TaqPath DuraPlex 1-Step RT-qPCR Master Mix Applied Biosystems™ TaqPath™ DuraPlex™ 1-Step RT-qPCR Master Mix is a benchtop-stable reagent optimized for rapid, sensitive, and reproducible detection of viral and bacterial pathogens, even in the presence of PCR inhibitors. The automation-ready master mix comes in a 4X concentrated formulation that is capable of multiplexing up to 6 targets in a single well. Formulations are available with and without ROX passive reference dye (Figure 1). TaqPath BactoPure Microbial Detection Master Mix Applied Biosystems™ TaqPath™ BactoPure™ Microbial Detection Master Mix is for clinical customers who need a rapid method for low-level DNA pathogen detection on a variety of targets using complex samples. We offer the TaqPath BactoPure master mix which—unlike competitors’ mixes—offers the lowest limit of detection across common microbial targets of interest (e.g., bacteria, as demonstrated by a 16S rRNA assay). TaqPath BactoPure master mix is available with or without ROX dye to be compatible with higher-order multiplexed assays. TaqPath ProAmp Master Mix Applied Biosystems™ TaqPath™ ProAmp™ Master Mix is for high-throughput genotyping and copy number variation protocols requiring uncompromising reliability and accuracy, even in the presence of inhibitors commonly found in clinical samples. It is designed to deliver sensitive and confident results from genomic DNA targets on a broad range of qPCR instrument platforms. TaqPath ProAmp Master Mix is manufactured under a strong ISO 13485 quality management system and is designed to produce consistent product performance, lot after lot. TaqPath qPCR Master Mix, CG Applied Biosystems™ TaqPath™ qPCR Master Mix, CG, is a 2X formulation designed for gene expression and miRNA analysis, containing a thermostable fast DNA polymerase and dNTPs in an optimized buffer solution for maximum robustness and reproducibility. For Laboratory Use. Learn more at thermofisher.com/qpcr-taqpathmastermix 30 25 20 15 10 5 0 Lot Cq Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 B2M FN1 FZD1 GAPDH RNase P TFRC Target RNase P 30 25 20 15 10 5 0 Lot Cq Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 B2M FN1 FZD1 RNase P RNase P TFRC Target Figure 1. Three unique lots of TaqPath DuraPlex 1-Step RT-qPCR Master Mix were tested for consistency in performance. (A) Cq values for all 6 gene targets are similar in a multiplex reaction tested with the version of the product with no passive reference dye. (B) Cq values for all 5 gene targets are similar in a multiplex reaction tested with the ROX version of the product. A B 15 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics For Laboratory Use. TaqPath DuraPlex 1-Step RT-qPCR Master Mix TaqPath BactoPure Microbial Detection Master Mix TaqPath ProAmp Master Mix TaqPath qPCR Master Mix, CG Check price or order now Check price or order now Check price or order now Check price or order now Recommended applications Pathogen detection, gene expression Microbial detection SNP genotyping, copy number variation Gene expression, microRNA analysis Target RNA DNA gDNA cDNA Multiplexing and passive reference dye With ROX dye (up to 5 targets) No ROX dye (up to 6 targets) With ROX dye (up to 3 targets) No ROX dye (>3 targets) With ROX dye (up to 3 targets) With Mustang Purple dye (>3 targets) With ROX dye (up to 3 targets) Assay recommendation Applied Biosystems™ TaqPath™ qPCR assays Request a sample* Request a sample* Request a sample* Request a sample* * No purchase necessary to receive evaluation sample. Participation is open only to life science professionals in the US (excluding Puerto Rico) and Canada who are 21 years or older. Completed evaluation sample request forms must be received no later than December 31, 2024, at 6:00 p.m. PT, or until evaluation samples are depleted, whichever comes first. Limit one evaluation sample per lab. By submitting your evaluation sample request response, you warrant that you are not prohibited by employment, contract, or law from accepting one evaluation sample from Life Technologies. Cannot be combined with other discounts or promotions. Offer void where prohibited, licensed, or restricted by federal, state, provincial, or local laws or regulation or agency/institutional policy. Other restrictions may apply. 16 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Applied Biosystems™ MicroAmp™ PCR plastics have been designed and tested to work with our instruments and enable optimal performance. MicroAmp qPCR plastics are: • Verifi ed on Applied Biosystems™ thermal cyclers for optimal fi t and performance • Designed to perform on all Applied Biosystems™ IVD qPCR instruments • Designed for optimal heat transfer, with thin-walled polypropylene wells • Designed to reduce cross-contamination, with raised well rims for eff ective sealing High-performance PCR plastics for optimal qPCR results MicroAmp qPCR plastics Applied Biosystems™ MicroAmp™ EnduraPlate™ optical microplates, GPLE Formats 96-well 96-well Fast 384-well DNA-, RNase-, and PCR inhibitor–free Yes ANSI/SBS standard dimension color Clear Instrument compatibility Use our plastics selection tool Barcode Yes (3 sides) Multiple applications Yes Optical compatibility Yes Which qPCR plastic is right for you? Find the plastic format with the throughput and features for your application For Laboratory Use. 17 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Find the plastics and accessories you need for your instrument quickly Product QuantStudio 7 Pro Dx system QuantStudio 5 Dx system Cat. No. 96-well, 0.2 mL reaction plates MicroAmp Optical 96-Well GPLE Reaction Plates (10 plates) • • 4481191 MicroAmp Optical 96-Well GPLE Reaction Plates with Barcode (10 plates) • • 4481192 MicroAmp EnduraPlate Optical 96-Well GPLE Clear Reaction Plates with Barcode (20 plates) • • 4483348 MicroAmp EnduraPlate Optical 96-Well GPLE Clear Reaction Plates with Barcode (500 plates) • • 4483351 384-well reaction plates MicroAmp Optical 384-Well GPLE Reaction Plates with Barcode (50 plates) • 4481195 MicroAmp EnduraPlate Optical 384-Well GPLE Clear Reaction Plates with Barcode (20 plates) • 4483319 Seals and covers MicroAmp Optical Adhesive Covers GPLE (25 films) • • A49767 Accessories Splash-Free 96-Well Base • • 4312063 96-Well Support Base • • 4379590 For Laboratory Use. In Vitro Diagnostic Use. 18 Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics Leveraging our state-of-the-art genetic sciences tools and solutions, the Licensing and Commercial Supply (LCS) team helps our partners commercialize assays within a wide range of applications, including infectious disease and oncology. Our team is aligned to help you navigate potential speed bumps on your path to commercialization by providing you value beyond just products in our partnerships. Our team also specializes in providing support for those in the ideation and feasibility phases. We bring the right mix of solutions you need to help you on your path and combine these solutions with the quality you can expect from Thermo Fisher Scientific. Evaluate options to build in-house or partner Partner/ build decision Functional and business requirements Development and optimization Initial trial Pilot of clinical studies Design transfer through regulatory clearance Product launch and maintenance Supply chain setup Regulatory documentation and support Design lock Feasibility Development Verification Validation Regulatory clearance On the market • Commercial use rights • Compliance documentation support • Custom assay development • Custom manufacturing • Globalized footprint • High-efficiency technology transfer • Novel content and technology • Product optimization • Quality products and services • Security of supply As part of Thermo Fisher, our global regulatory team with expertise in established quality management systems; FDA-, NMPA-, CE-IVD (including IVDR)–compliant facilities; manufacturing quality standards; and global trade compliance can support your business, allowing you the freedom to focus on your priorities. Commercial supply partnerships for MDx assay developers Example client assay development process We begin working with your leadership team in the development of a value proposition to identify the solution best suited for your success. Your innovation can receive the highest benefit from partnering during the feasibility and development stages, prior to locking in your design. Our support varies depending on where you are in your development process and includes: 19 Further explore our molecular diagnostic offerings at thermofisher.com/qpcr-molecular-diagnostics For In Vitro Diagnostic Use. © 2020–2024 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Alexa is a trademark of Amazon Technologies, Inc. Microsoft, Edge, and Windows are trademarks of Microsoft Corporation. Google and Chrome are trademarks of Google LLC. Mozilla and Firefox are trademarks of the Mozilla Foundation. Apple and Safari are trademarks of Apple Inc. COL36076 0724