- September 15, 2020
- Posted by: Stratford Team
- Category: Markets
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.
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.
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