CENTOGENE Provides Corporate and Business Unit Update

“This past year saw CENTOGENE realizing a number of significant milestones, including forming global partnerships with leading pharmaceutical companies, an expansion of our leadership team, significant results in the development of proprietary biomarkers, and the opening of our U.S.-based laboratory located in the heart of the Massachusetts biotech hub,” said Dr. Arndt Rolfs, CEO and founder of CENTOGENE.

“As medical companies, academia, clinicians and governments continue to focus on the potential impact of genetics in treating rare diseases, we remain focused on building a global understanding of the genetic basis and the clinical phenotype of rare hereditary diseases. For 2019, we look forward to continuing to make an impact on the identification and treatment of rare disease patients among the more than 7,000 identified rare diseases around the world.”

Pharmaceutical Business

CENTOGENE provides solutions to its pharmaceutical partners in order to help accelerate the development of orphan drugs, including early patient recruitment and identification, epidemiological and patient population sizing insights, biomarker discovery and patient monitoring, and follow-up. Highlights of 2018 strategic partnerships include:

• Collaboration with Denali Therapeutics for the global identification and recruitment of LRRK2 mutation carrier Parkinson’s disease patients.
• Global collaboration with Evotec AG to develop a strategic high-throughput platform for testing novel small molecules in rare hereditary metabolic diseases.
• Support for Orphazyme’s clinical trial efforts in India for the use of the small molecule arimoclomol, for the treatment of neuronopathic Gaucher disease.
• Collaboration with Aldeyra Therapeutics to identify patients around the world with Sjögren-Larsson Syndrome to understand the clinical spectrum of this disease.
• Strategic collaboration with Chiesi Germany in lysosomal storage disease with a special focus on Alpha Mannosidosis in Europe, a rare genetic disorder affecting approximately 1 in 1,000,000 newborns.

Research and Development

In 2018, 23 manuscripts with CENTOGENE scientific contributions were published in leading journals including Genetics in Medicine, Human Genetics, Journal of Medical Genetics, Movement Disorders and the European Journal of Human Genetics. Additional 2018 R&D highlights include:

• CENTOGENE commercialized proprietary biomarkers for use on the CentoCard^®: Niemann-Pick disease type A/B, Farber and Niemann-Pick disease type C, Gaucher disease, Fabry disease, and hereditary Angioedema. In addition to the above commercialized biomarkers, the Company has over 40 additional biomarkers currently in development.
• Large biomarker development projects have been concluded with further patent filings.

Digital Solutions

Our CentoMD^® database, which we believe is the world’s largest curated mutation database for rare diseases, offers the most complete and up-to-date information across epidemiologic, phenotypic, and genetic data, and biomaterials of more than 300,000 patients. 2018 updates to the CentoMD^® product family include:

• CentoMD^® for research/annotation purposes – now in its fourth year and version 5.3 released in December.

MyPatientApp (MyLSDApp)

• Launched in the AppStore for Android/iOS in Germany, Pakistan, Israel and U.S. – an innovative approach to patient support and measuring LysoGb1 biomarker for the treatment of Gaucher disease.

CentoPortal^®

• Two releases of the safe, simple and yet high quality solution for physician’s genetic diagnostics workflow, from test ordering to report sharing.

Clinical Diagnostics and Laboratory Operations

Through its distribution partners, physicians, labs and hospital clients, CENTOGENE offers the broadest diagnostic testing portfolio for rare diseases, covering over 3,800 genes based on Sanger sequencing and using over 9,000 different tests. 2018 highlights include:

• CENTOGENE’s extensive data repository now contains phenotypic, epidemiological and genetic and/or biochemical data from more than 350,000 patients, and a biobank which holds biomaterials from the blood samples of these patients. Patients are sourced from more than 100 countries, reflecting the genetic differences in global ethnicities.
• CENTOGENE expanded its Cambridge-based clinical studies team, which supports its own biomarker development studies, providing functional validation and therapy guidance as well as supporting biopharmaceutical collaborations. On the diagnostics front, the sample number for clinical diagnostics grew again significantly

Corporate Highlights

• Berndt Modig was appointed as a member of the Supervisory Board, and CENTOGENE expanded its senior leadership team with the appointment of Dr. Dirk Ehlers to Chief Operating Officer, Oved Amitay to Chief Business Officer, and Dr. Anton Mamin to Director of Clinical Trials.
• In June, CENTOGENE announced the opening of its first U.S. laboratory in Cambridge, Massachusetts, which will serve as the touch point for partners who wish to leverage diagnostic services in the U.S. The new CLIA accredited space features a state-of-the-art high-throughput genetic testing laboratory along with biochemical, proteomic, metabolomic and genetic analysis capabilities from various patient sample materials, such as CentoCard^® - CENTOGENE’s dried blood spot card solution, buccal swab, full blood or purified DNA.
• Notably, Dr. Arndt Rolfs was appointed to the Global Commission to end the Diagnostic Odyssey for Children, a project created by Shire, Microsoft and EURORDIS to transform the lives of children with rare diseases.

“Looking ahead at 2019, we are excited about our strategic focus on strengthening partnerships and broadening our footprint both in Europe and in the U.S., and continuing to integrate and enhance all our digital products,” added Dr. Rolfs. “We will continue to expand our artificial intelligence initiatives to discover new insights in our data that will help in the development and characterization of longitudinal biomarkers and support the development of more personalized medicines in order to accelerate the development of orphan drugs.”

About CENTOGENE

Centogene is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including our epidemiological and clinical heterogeneity, and our innovative biomarkers.

As one of the largest rare disease companies worldwide, Centogene is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families. www.centogene.com

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