Diatherix Eurofins' SARS-CoV-2 Test Receives FDA Emergency Use Authorization

HUNTSVILLE, Ala., April 29, 2020 /PRNewswire/ -- Diatherix Eurofins, a leader in respiratory viral and bacterial testing, announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its SARS-CoV-2 assay.  

Diatherix has been at the forefront of SARS-CoV-2 testing, launching its highly sensitive and specific assay to thousands of existing and new clients on March 17, 2020. The CAP-accredited and CLIA-certified laboratory has capacity for up to 5,000 SARS-CoV-2 tests per day and offers clients one-day results.  Diatherix Eurofins' LDT (Lab Developed Test) for SARS-CoV-2 utilizes a proprietary technology called, TEM-PCR™ (Target Enriched Multiplex Polymerase Chain Reaction).  This innovative, molecular technology was designed to overcome the challenges that exist with conventional laboratory methods. 

Diatherix works with hospitals, physicians' offices, nursing homes, and reference labs nationwide. Diatherix accepts respiratory specimen sources to detect active SARS-CoV-2 infection. Currently, Diatherix has capacity to receive additional specimens daily with results provided the same day as specimen receipt.

For more information on Diatherix's SARS-CoV-2 assay, visit: www.eurofins-diatherix-covid-19.com. 

ABOUT THE DIATHERIX COVID-19 PANEL

In addition to its single, FDA authorized, SARS-CoV-2 assay, Diatherix has also developed a COVID-19 panel.  Using a single sample, this panel can identify whether the patient has multiple infections in just one day, including: SARS-CoV-2, Chlamydophila pneumoniae, Haemophilus influenzae (Haemophilus influenzae type B), Moraxella catarrhalis, Mycoplasma pneumoniae, and Streptococcus pneumoniae. 

ABOUT DIATHERIX EUROFINS

Diatherix Eurofins 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 – a global leader in bio-analysis

Eurofins Scientific, through its subsidiaries (hereinafter "Eurofins" or "the Group"), believes it is a 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 clinical diagnostic testing. With over 47,000 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 biological substances and 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 companies 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).

SOURCE Diatherix Eurofins