COVID-19 test receives FDA approval in the Philippines

PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt" or the "Company"), an international specialist in clinical diagnostics, announces that Primerdesign, its molecular diagnostics division, has signed a global distribution agreement for its COVID-19 test with Bruker-Hain Diagnostics, the molecular diagnostics products business unit of Bruker Corporation (Bruker).

Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test is validated for use on Bruker-Hain Diagnostics’ GenoXtract^® automated nucleic acid extraction device and associated extraction kits. It is under validation on Bruker’s new FluoroCycler^® XT PCR instrument, allowing Bruker to provide a full solution from automated extraction to result. Bruker has already initiated shipments of the Primerdesign test into Spain, France, Germany and UK.

The Company also announces that the Republic of the Philippines Department of Health Food and Drug Administration has approved the Company’s COVID-19 test for commercial use, effective immediately.

Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, commented:

“Bruker is committed to bringing innovative new diagnostics into the market and through this agreement we are joining the fight against the COVID-19 disease. In combination with our proven and validated GenoXtract (GXT) products for nucleic acid extraction, we can offer a powerful solution for preparation and detection of the SARS-CoV-2 virus. We are delighted to be partnered with Novacyt.”

Graham Mullis, Chief Executive Officer of Novacyt, added:

“This agreement is another important endorsement of our COVID-19 test and is another way in which we can ensure it is distributed to a wide range of laboratories as we continue to tackle this global pandemic. In Bruker, we have found a strong international partner with a wide reach into European laboratories and look forward to building on this relationship. We are also pleased to have received approval from the FDA in the Philippines and look forward to supporting this new market.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

About Novacyt Group

The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.

For more information please refer to the website: www.novacyt.com

About COVID-19

Researchers at the Chinese Centre for Disease Control and Prevention and their collaborators have sequenced the 2019 novel coronavirus (COVID-19) pathogen from patient samples and have found it to be genetically distinct from the severe acute respiratory syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as well as from the Middle East respiratory syndrome (MERS) virus that was detected in 2012.

About Bruker-Hain Diagnostics

Bruker-Hain Diagnostics was formed after the recent acquisition of the Hain Lifescience GmbH as a Business Unit for Molecular Diagnostics (MDx) products in Bruker's Microbiology & Diagnostics business. Hain Lifescience GmbH is the legal manufacturer of the Fluorocycler XT, MTBDR 2.0 assay and of GXT nucleic acid preparation kits. For more information, please visit, www.hain-lifescience.de.

About Bruker Corporation (Nasdaq:BRKR)

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit: www.bruker.com.

Contacts

Novacyt SA
Graham Mullis, Chief Executive Officer

Anthony Dyer, Chief Financial Officer

+44 (0)1276 600081

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson / Charlie Bouverat (Corporate Finance)

Vadim Alexandre / Rob Rees (Corporate Broking)

+44 (0)20 3470 0470

FTI Consulting (International)
Victoria Foster Mitchell / Mary Whittow

+44 (0)20 3727 1000

[email protected] / [email protected]

FTI Consulting (France)
Arnaud de Cheffontaines

+33 (0)147 03 69 47

[email protected]