CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 02, 2020 (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, today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 RT-PCR test.

Prof. Arndt Rolfs, CEO of CENTOGENE, said, “Over the past several months, we have been working tirelessly to ensure that we provide the best possible molecular diagnostic testing to prevent the further outbreak of COVID-19 and support the return to a new normal. This authorization by the FDA is another milestone for our COVID-19 testing efforts that validates the quality, precision and reliability of our tests.”

“CENTOGENE is proud to have received this accelerated authorization from the FDA, which recognizes our continued commitment to the highest quality standards amid this global pandemic,” said Ellen Karges, SVP Regulatory Compliance & Quality Management. “Molecular testing is vital in diagnosing patients as early as possible, and we are confident that our test will support a successful fight against this novel outbreak especially in collaboration with our pharmaceutical partners, educational organizations and airports.”


CENTOGENE’S SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2, the underlying virus causing COVID-19. It is intended to be used with samples of the upper respiratory tract (oropharyngeal swabs) collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.

The test is intended for use by qualified laboratory personnel to be performed in CENTOGENE’s CLIA certified high-complexity laboratories in Germany.


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 approximately 2.5 billion weighted data points from approximately 500,000 patients representing over 120 different countries as of December 31, 2019.

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 December 31, 2019, the Company collaborated with over 39 pharmaceutical partners covering over 45 different rare diseases.

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