The world leader in serving science

Supporting Your Molecular Diagnostic Assay Development with OEM Commercial Supply Partnerships Todd HowrenAssociate Director, Business Development

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Navigating the Challenges of Molecular Diagnostic (MDx) Development

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Manufacture products

• ISO 9001, ISO 13485, GMP certified

• Custom configuration, QC, and packaging

• Capacity and scale

• Private labeling

• Global supply chain

Licensing and supply

agreements

• Long-standing expertise in agreements

• Out-licensing

• Change control

• Security of supply

Customize products

as needed

• Comprehensive development and customization capabilities

• Process control

• Pilot lab/prototyping capabilities

Select products from our portfolio

• Extensive collection of technologies and tools for genetic analysis

• Thermo Fisher Scientific

• Applied Biosystems

• Invitrogen

• Evaluate options and alternatives

How We Work With You: One Strategic Partner

Evaluate workflow needs

• Meet with our dedicated licensing and commercial supply team

• In-depth product and capabilities knowledge

• Confidentiality

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Navigating the Challenges of Molecular Diagnostic (MDx) Development

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Molecular Diagnostic Assays with Endpoint & Real-Time PCR Platforms

Samples and controls

Enzymes, master mix and assays

Instrument & Plastics Results Analysis+ +

• Gene expression

• Genotyping

• Copy number variation

• Pathogen detection/ quantitation

• Mutation detection

• Validated according to laboratory guidelines (CLIA, CAP, ISO)

• Limited to laboratory that developed the assay

• Exempt from premarket approval

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Lyo-ready DNA Polymerases and Reverse Transcriptases

The largest selection lyo-ready enzymes:

• Glycerol-free composition for lyophilization-compatible formulation

• Available in industry-leading brands (e.g., Platinum, Phusion, SuperScript and more)

• Supplied in bulk or custom sizes

• Manufactured in ISO 13485 certified facility

• Applications:• Real-time PCR, endpoint PCR• Genotyping & NGS• Component of master mix

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Single-Use System Manufacturing of DNA-free PCR Reagents

SUS

Leveraging our expertise in enzyme development, the DNA-free DNA polymerases and reverse transcriptases are manufactured using Single-Use System (SUS) technology

• Closed, controlled and disposable system

• Validated QC methods with detection limits 100x lower than competing “DNA-free” enzymes

• Manufactured in ISO 13485 certified facility

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SUS for Enzyme Production

Closed, controlled and disposable system: • Eliminated external contamination risks from operator and environment• Superior purification techniques used to remove host cell DNA to below detection limits

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Our Ongoing Commitment to Clinical Customers

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7500 F Real-time PCR Systems

7500 F Dx Real-time PCR System

QuantStudio 6/7 Systems

QuantStudio Dx Real-time PCR System

QuantStudio 3/5 Systems

QuantStudio 5 Dx Real-time PCR System

The QuantStudio 5 Dx Real-Time PCR System is coming soon. Product not yet CE-marked. Cannot be sold or put into service.

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QuantStudio 5 Dx -- A modern diagnostic instrument for today's smart labs

Intuitive touchscreen interface

Intuitive touchscreen interface

Multi-modal software for IVD and assay development

Multi-modal software for IVD and assay development

0.2mL VeriFlex Block

White LED opticsWhite LED optics

The QuantStudio 5 Dx Real-Time PCR System is coming soon. Product not yet CE-marked. Cannot be sold or put into service.

High performance 1.5 fold detection, 9 logs of linear range

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Continuing our innovation in Sanger Sequencing and Fragment Analysis, the SeqStudio Genetic Analyzer provides you an integrated experience:

• all-in-one cartridge for easy set up and reduced hands-on time

• ease of use with plug-and-play reagents, individualized protocolsand intuitive touchscreen

• flexibility for both sequencing and fragment analysis in a single run.

• run time of as little as 30 minutes for fast turnaround time

• high performance data for oncology and inherited disease research as well as microbial pathogen identification

Introducing Applied Biosystems™ SeqStudio™ Genetic Analyzer

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Faster timeto market

• Established IVD platforms may help enable a shorter path to compliance

• Experience developingIVD products

Partner rather than vendor

• Comprehensive custom development and manufacturing capabilities

• Timely technical support

• Dedicated OEM teams

• 25+ years in OEM business

Simplified supply chain

• Unrivaled breadth and depth of the portfolio

• Change control notifications

• Reserve lots

• Special payment terms

• Convey rights for commercial use

Securityof supply

• Comprehensive raw materials and process controls

• Multiple manufacturing sites

• Company reputation

• Financial stability

• Confidentialityobligations

Sustainable Partnership to Meet Your Needs

Quality and performance

• 40+ years in life sciences

• Robust quality systems

• ISO 9001, ISO 13485

• Openness to buyer audits

• Both RUO reagents andIVD instrumentations

The world leader in serving science

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