Eurofins Diatherix launches Flu Plus to identify SARS-CoV-2 and five additional viruses

As a leader in respiratory viral and bacterial testing, Eurofins Diatherix is pleased to announce the development of Flu Plus, a new test added to its proprietary respiratory testing portfolio. Specimens have been accepted for testing as of 10 September 2020.

Diatherix received Emergency Use Authorization from the FDA for their SARS-CoV-2 virus test on 22 April 2020. Eurofins laboratories (including Diatherix) have completed over one million COVID tests to date in the US, and are pleased to leverage extensive respiratory and infectious disease expertise to continue to assist clinicians in their response to COVID-19. To this end, Diatherix has developed the Flu Plus test which includes the unmodified EUA approved SARS-CoV-2 virus along with five additional viral pathogens which can be used to assist healthcare providers with the accurate identification of the most prevalent viruses associated with respiratory illnesses. These five viral pathogens include Influenza A, A(H1N1)pdm09, Influenza B, Respiratory Syncytial Virus (A&B), and Human Rhinovirus/Enterovirus which can be known to exacerbate the recovery for high-risk patients.

This new test complements Diatherix’s existing testing options for COVID-19, which includes the SARS-CoV-2 single target test, our unique COVID-19 test which offers the SARS-CoV-2 virus plus 5 additional synergistic bacterial organisms, and the ability to order the SARS-CoV-2 virus with our existing Respiratory, Viral Respiratory, Influenza, Upper Respiratory and Pediatric Respiratory tests.

Furthermore, Diatherix accepts six specimen collection methods including Nasal Swab, Nasopharyngeal Swab, Nasopharyngeal Aspirate/Wash, Throat Swab, Bronchial Aspirate, and Sputum Specimen Swab.

Diatherix works with hospitals, physicians’ offices, nursing homes, and reference labs nationwide. All testing will be performed pursuant to Diatherix’s one-day turnaround times – test results will be provided back to clinicians the same day of specimen receipt.

Note: at this time, Eurofins Diatherix cannot accept specimens from the state of New York.

Diatherix Eurofins SARS-CoV-2 virus has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Notes to Editors:

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About Eurofins Diatherix

Eurofins Diatherix utilizes TEM-PCR™ (Target Enriched Multiplex Polymerase Chain Reaction), an innovative proprietary molecular technology, to deliver high throughput, one-day results. TEM-PCR™ was designed to overcome the challenges that exist with conventional laboratory methods, while identifying bacteria regardless of recent antibiotic use, and difficult-to-culture pathogens. The benefits to clinicians include reduced antibiotic utilization, improved patient outcomes, cost reduction and avoidance, and improved patient satisfaction.

About Eurofins – the global leader in bio-analysis

Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 48,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.

Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.

As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.

Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

Until it has been lawfully made public widely by Eurofins through approved distribution channels, this document contains inside information for the purpose of Regulation (EU) 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse, as amended.

Important disclaimer:

This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgment of Eurofins Scientific’s management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company’s management as of the date of publication, but no guarantees can be made as to their completeness or validity.

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