Boehringer Ingelheim Biopharmaceuticals GmbH

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Collaborations Biotype GmbH

Moritzburger Weg 67 01109 Dresden Germany Dr Kathleen Clauß +49-351-8838-400 +49-351-8838-403 info@biotype.de www.biotype.de www.modaplex.biotype.de www.custom-solutions.biotype.de

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85 1999 S1, BSL-2 ISO 13485 & ISO 9001 certified

| Molecular diagnostics | In-vitro diagnostics | Contract development | Contract manufacturing

Strong network with numerous industry and academic partners Member of the Molecular Diagnostics Group (MDG); contributing solutions for healthcare, personalized medicine & digitalization

Company Profile

Biotype is a German biotechnology company that develops, manufactures, and distributes molecular in-vitro diagnostic kits for the detection and quantification of DNA- and RNA-based biomarkers. With over 20 years extensive expertise in the field of diagnostics, Biotype also provides contract development and manufacturing services. The company’s goal is to provide its customers, such as labs, pharma, and diagnostic companies with quality diagnostic tools & services.

Assays for Molecular Diagnostics

Biotype’s portfolio of molecular diagnostic kits is used in routine laboratories supporting diagnosis and therapy in various molecular applications, such as oncology, hematology, pathogen detection, forensics, and veterinary.

Proprietary Modaplex Platform

Biotype offers a unique PCR benchtop system that simplifies the complexity of molecular diagnostics. With little hands-on time and a simple workflow, the Modaplex platform can › Detect, differentiate, and quantify up to 50 DNA &

RNA targets per well › Measure up to 48 samples simultaneously › Detect all types of genetic aberrations simultaneously in a 3.5-hour run

A selection of tests on the Modaplex platform: › Gene Expression › Mutations › Polysomy › Copy Number Variations › Methylation › Gene Fusion › Micro RNA › Splicing Variants

The Modaplex System is available for co-development and out-licensing.

Contract Development and Manufacturing Services

The following points characterize Biotype’s Custom Solutions for molecular & immuno-based diagnostic tests:

Assay Development & Performance Evaluation › Extensive experience in the field of molecular diagnostics and in-vitro diagnostics › Modular development process following Design

Control Guidelines: From your idea to a marketable

CE-IVD product › Bioinformatic analyses using state-of-the-art tools including machine learning and artificial intelligence for various types of biomarkers › Flexibility in biomarkers and platform technologies › Analytical and clinical performance studies

Assay Manufacturing › Customized and cost-effective manufacturing processes (manual or high throughput automation) › Flexible batch sizes and formats to meet your needs › Production under clean room conditions › Supply chain management › Whole-process quality control › Customized packaging and kit assembly

Regulatory Affairs & Registration Services › Assay validation on multiple platforms › IVDR support › Establishment and writing of all required documents › Application and CE registration

Biotype will meet your outsourcing needs with › Rapid implementation › Flexibility › Transparency › High commitment