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CENTOGENE Reaches 10,000 Participant Milestone in Global Parkinson’s Disease Study

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Centogene N.V. (Nasdaq: CNTG) has reached a significant milestone in its Rostock International Parkinson's Disease (ROPAD) Study by recruiting 10,000 participants, making it the largest genetic study on Parkinson's disease globally. With over 120 study sites worldwide, the focus is on understanding the role of genetics in Parkinson's progression, diagnosis, and treatment. The study includes a collaboration with Denali Therapeutics on targeted patient recruitment linked to LRRK2 mutations, potentially paving the way for new therapeutic options.

Positive
  • 10,000 participants recruited for ROPAD Study, enhancing the genetic understanding of Parkinson's disease.
  • Largest global study with over 120 sites, increasing diversity and data richness.
  • Collaboration with Denali Therapeutics to identify patients with LRRK2 mutations for future clinical studies.
Negative
  • None.
  • Rostock International Parkinson's Disease (ROPAD) Study aims to characterize the genetics of PD to establish a better understanding of the disease progression, diagnosis, and treatment
  • Significant milestone of 10,000 participants reached
  • With over 120 study sites around the world, CENTOGENE is leading the largest corresponding study for genetics in Parkinson’s disease ever performed

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, March 09, 2021 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, announced today a significant milestone in its Rostock International Parkinson's Disease (ROPAD) Study, with the recruitment and genetic testing of 10,000 participants. Including more than 120 study sites around the world, CENTOGENE is leading the largest study of its kind – a global observational study focusing on the role of genetics in Parkinson's disease (PD).

Prof. Peter Bauer, Chief Genomic Officer at CENTOGENE, said, "We are pleased to have reached such a pivotal point in our Parkinson’s disease study. All too often clinical studies do not provide adequate ethnic diversity, and we are proud that this study has included over 10,000 participants from around the world. Going forward, we hope to use these deep insights into Parkinson's disease genetics to diagnose patients at the earliest point possible and contribute to targeted Parkinson’s treatments.”

In 2018, CENTOGENE entered into a strategic collaboration with Denali Therapeutics for the targeted global identification and recruitment of Parkinson’s disease patients with mutations in the LRRK2 gene. Mutations in LRRK2 are one of the most commonly known genetic causes of Parkinson’s disease. Patients enrolled in ROPAD with an LRRK2 mutation may be eligible for participation in future therapeutic clinical studies, including with Denali Therapeutics, which is developing a small molecule, LRRK2 inhibitor for the treatment of Parkinson’s disease in collaboration with Biogen.

About ROPAD

The Rostock International Parkinson's Disease Study (ROPAD) is a global epidemiological study focusing on the role of genetics in Parkinson's disease (PD). The major goal of the study is to characterize the genetics of PD to establish a better understanding of the disease etiology, diagnosis, and severity.

CENTOGENE utilizes CentoCard®, the Company’s proprietary, CE-marked dried blood spot collection kit in combination with state-of-the-art sequencing technologies to screen for mutations in LRRK2 and other PD-associated genes. Throughout this study, 10,000 participants from around the world have been tested over a two-year period.

Patients with mutations in PD genes are offered further clinical assessment in a supplementary study, ‘Lübeck International Parkinson’s Disease Project (LIPAD)’, conducted at the University of Lübeck where a detailed phenotyping of participants will be performed. Participants may be offered participation in future interventional clinical studies, including with study partner Denali Therapeutics, which is developing a small molecule, LRRK2 inhibitor for the treatment of Parkinson’s disease in collaboration with Biogen.

The ROPAD Study protocol and initial findings were recently published in the journal Movement Disorders: https://pubmed.ncbi.nlm.nih.gov/33314351/

About CENTOGENE

CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 595,000 patients representing over 120 different countries as of September 30, 2020.

The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of September 30, 2020, the Company collaborated with over 40 pharmaceutical partners covering over 45 different rare diseases.

Important Notice and Disclaimer

This press release contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities, and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties, and other variable circumstances, such as negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and govern-mental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2019, on Form 20-F filed with the SEC on April 23, 2020, Form 6-K containing our financial results for the three months ended March 31, 2020, furnished to the SEC on June 15, 2020, Form 6-K containing our financial results for the three and nine months ended September 30, 2020, furnished to the SEC on December 16, 2020, and other current reports and documents furnished to or filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.


FAQ

What is the significance of the 10,000 participants in the CNTG ROPAD Study?

The recruitment of 10,000 participants marks a significant milestone, making it the largest genetic study focused on Parkinson's disease globally.

How does the CNTG ROPAD Study aim to impact Parkinson's disease treatment?

The study seeks to deepen the understanding of the genetics of Parkinson's disease to improve diagnosis and contribute to targeted treatments.

What collaboration is Centogene involved in related to the ROPAD Study?

Centogene collaborates with Denali Therapeutics to recruit Parkinson's disease patients with LRRK2 mutations, which may lead to future therapeutic clinical studies.

How many study sites are involved in the CNTG ROPAD Study?

There are over 120 study sites around the world involved in the ROPAD Study.

What role do LRRK2 mutations play in the CNTG ROPAD Study?

LRRK2 mutations are among the most common genetic causes of Parkinson's disease, and patients with these mutations may qualify for future therapeutic studies.

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